Announcement • Aug 05
Innocare Pharma Orelabrutinib in Combination with Mesutoclax Granted Breakthrough Therapy Designation in China InnoCare Pharma announced that orelabrutinib, in combination with mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy. Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy. Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax is the first BCL2 inhibitor granted BTD recognition in China for the treatment of mantle cell lymphoma (MCL) in patients previously treated with a BTK inhibitor. This is the second BTD granted to the novel BCL2 inhibitor. Data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that orelabrutinib in combination with mesutoclax achieved excellent efficacy and safety in patients with MZL who had received at least one prior therapy, with an overall response rate (ORR) of 100%. MZL is an indolent B-cell non-Hodgkin's lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with relapsed or refractory MZL lack effective treatment options. The BTD aims to accelerate the clinical development and approval of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. Announcement • Jul 27
InnoCare Pharma Limited Announces Fadeucravacitinib Phase III Registrational Trial in Moderate-To-Severe Plaque Psoriasis Successfully Meets Primary Endpoint InnoCare Pharma Limited announced that the Phase III registrational clinical trial of fadeucravacitinib (ICP-488), a potent and highly selective tyrosine kinase 2 (TYK2) allosteric inhibitor, for the treatment of patients with moderate-to-severe plaque psoriasis, has successfully met its primary endpoint. The Phase III study is a randomized, double-blind, placebo-controlled, multicenter registrational clinical trial designed to evaluate the efficacy, safety and tolerability of fadeucravacitinib (ICP-488) in adult patients with moderate-to-severe plaque psoriasis. The study demonstrated that fadeucravacitinib (ICP-488) achieved the primary endpoint with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures. Detailed efficacy and safety data from the study will be presented at upcoming international scientific congresses and submitted for publication in peer-reviewed medical journals. The safety profile of fadeucravacitinib (ICP-488) was consistent with previous clinical studies, and no new safety signals were identified. Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous plaques, scaling, and systemic inflammatory involvement, with significant long-term physical and psychological impact. Although biologic therapies have transformed disease management, limitations remain, including high treatment costs, injection-related burden, long-term safety concerns, and loss of response over time. There is a clear demand for effective oral therapies that combine strong efficacy, durable disease control, and favorable safety for chronic use. Fadeucravacitinib (ICP-488) is a small molecule inhibitor of the pseudo kinase domain JH2 of TYK2. JH2 has an important regulatory role in TYK2 kinase catalytical activity, and mutations in JH2 have been shown to be the cause of or be linked with impaired TYK2 activity. Fadeucravacitinib (ICP-488) is a potent and selective TYK2 allosteric inhibitor that, by binding to the TYK2 JH2 domain, blocks IL-23, IL-12, type I interferon and other autoimmune cytokine receptors. The company intend to develop fadeucravacitinib (ICP-488) for the treatment of autoimmune diseases such as psoriasis, CLE, Sjögren’s syndrome, etc. The Company will continue to complete the ongoing Phase III study, including the long-term safety follow-up, and plans to advance the regulatory filing process for fadeucravacitinib (ICP-488) for the treatment of moderate-to-severe plaque psoriasis following the completion of the study. Announcement • Jul 18
InnoCare Pharma Limited Reports Positive Topline Results From The Phase II Portion Of The Phase II/III Adaptive Study Of Soficitinib (ICP-332) In Non-Segmental Vitiligo InnoCare Pharma Limited made this announcement on a voluntary basis to inform shareholders and potential investors of the Company’s latest business developments. The board of directors of the Company announced that the Phase II portion of the ongoing Phase II/III adaptive clinical study of soficitinib (ICP-332), the Company’s internally discovered and developed next-generation oral tyrosine kinase 2 (TYK2) inhibitor, in adult patients with non-segmental vitiligo has successfully met its primary endpoint. The ongoing study is a Phase II/III randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical study designed to evaluate the efficacy and safety of soficitinib (ICP-332) in patients with non-segmental vitiligo. The study consists of a Phase II portion followed by a Phase III portion. The Phase II portion met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements versus placebo at Week 24. Treatment with soficitinib (ICP-332) also demonstrated consistent efficacy across multiple secondary endpoints. At Week 24, treatment with soficitinib (ICP-332) resulted in significant improvements from baseline in Facial Vitiligo Area Scoring Index (F-VASI). The least-squares mean percent change from baseline in F-VASI was 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo group. Both soficitinib (ICP-332) dose groups demonstrated statistically significant improvements versus placebo (P<0.0001). The safety profile of soficitinib (ICP-332) was consistent with previous clinical studies. The treatment was well tolerated, and no new safety signals were identified. Detailed efficacy and safety results from the Phase II portion will be presented at upcoming international scientific congresses and submitted for publication in a peer-reviewed medical journal. The ongoing Phase II/III adaptive study will continue in accordance with the study protocol. Soficitinib (ICP-332) is a next-generation, highly selective oral TYK2 inhibitor discovered and developed by the Company. TYK2 is a member of the JAK family and plays a critical role in transducing signals downstream of IL-12/IL-23 family interleukin receptors as well as type I interferon receptor. These cytokine/receptor pathways regulate the activity of T helper 17, T helper 1, B and myeloid cells, which are critical in the pathobiology of multiple autoimmune and chronic inflammatory diseases including psoriasis, inflammatory bowel disease, lupus, atopic dermatitis, etc. Soficitinib (ICP-332) was designed to be a potent and selective TYK2 inhibitor with 400-fold selectivity against JAK2 with the aim of minimizing adverse events associated with nonselective JAK inhibitors. By selective inhibition of TYK2, soficitinib (ICP-332) has the potential to provide meaningful therapeutic benefit for multiple autoimmune diseases with a potentially favorable safety profile. As of the date of this announcement, soficitinib (ICP-332) is being evaluated across five autoimmune indications, including atopic dermatitis, vitiligo, prurigo nodularis, chronic spontaneous urticaria and psoriasis, with multiple clinical data readouts expected. Announcement • Jul 16
Innocare Pharma Reports Phase Ii Study Results of Tyk2 Inhibitor Soficitinib Meet Primary Endpoint in Patients with Vitiligo InnoCare Pharma announced that the Phase II portion of the Phase II/III trial of its TYK2 inhibitor Soficitinib (ICP-332) for non-segmental vitiligo has met the primary endpoint. The study is a Phase II/III randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical trial. The study consists of a Phase II portion followed by a Phase III portion. Phase II results showed that, at Week 24, treatment with soficitinib resulted in significant improvements from baseline in Facial Vitiligo Area Scoring Index (F-VASI). The least-squares mean percent change from baseline in F-VASI was 38.8% in the 80 mg once-daily group and 41.2% in the 120 mg once-daily group, compared with 2.2% in the placebo group. The two soficitinib dose groups demonstrated statistically significant improvements versus placebo. Announcement • Jul 15
InnoCare Pharma Reports Phase III Study Results Of TYK2 Inhibitor Soficitinib Meet Primary Endpoint In Patients With Atopic Dermatitis InnoCare Pharma announced that registrational phase III clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor soficitinib (ICP-332) met the primary endpoint in patients with moderate-to-severe atopic dermatitis (AD). The Phase III study is a randomized, double-blind, placebo-controlled, multicenter registrational clinical trial designed to evaluate the efficacy, safety and tolerability of soficitinib in patients with moderate-to-severe AD. The study demonstrated that soficitinib achieved the primary endpoint with statistical significance and clinically meaningful improvement. In addition, multiple secondary endpoints were successfully met, demonstrating a consistent treatment effect across efficacy measures. Soficitinib also showed a good safety profile, which was consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data from the study will be presented at upcoming international scientific congresses and/or academic journal. Soficitinib is a potent and selective oral TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, psoriasis, nodular prurigo and chronic spontaneous urticaria, etc. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases. According to the WHO Global Burden of Disease study, AD affects as many as 230 million people globally, ranking first in disease burden among non-fatal diseases worldwide. In China, the number of patients with AD is nearly 70 million, and the prevalence is increasing year by year. Announcement • Jul 14
InnoCare Pharma Publishes Phase 3 Results Demonstrating Orelabrutinib Significantly Prolongs Progression-Free Survival In Treatment-Naïve CLL/SLL InnoCare Pharma announced that Signal Transduction and Targeted Therapy (STTT), a Nature Portfolio journal, published a paper titled "Orelabrutinib versus chemoimmunotherapy in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma: a randomized, phase 3 trial." The paper concludes that orelabrutinib significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death by 68%. Orelabrutinib achieves deeper and more durable responses, demonstrates a higher overall response rate (ORR), and exhibits an excellent safety profile, positioning it as an effective first-line treatment option for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The primary endpoint was PFS as assessed by independent review committee (IRC). Secondary endpoints included overall response rate (ORR) and duration of response (DoR) assessed by both IRC and investigators, safety, etc. Results assessed by the IRC demonstrated that orelabrutinib significantly prolongs PFS, with a hazard ratio (HR) of 0.32 (p < 0.0001). The research team observed consistent trends across all prespecified subgroups. Orelabrutinib showed superior survival benefits over the control group in patients with advanced age, Rai stage III/IV, or presented with high-risk factors such as del(11q), unmutated IGHV, or bulky disease. The ORR in the orelabrutinib group reached 90.1%, significantly higher than the 79.2% in the control group. A post-hoc updated analysis at 30-month follow-up showed a complete response (CR) rate of 12.1% in the orelabrutinib group. The DoR in the orelabrutinib group was also significantly longer than in the control group, with an HR of 0.30. From a safety perspective, the incidence of any-grade treatment-related adverse events (TRAEs) with orelabrutinib was comparable to that of the control group, despite a median treatment duration in the orelabrutinib group (nearly 19.3 months) being nearly four times longer than that in the control group (5.2 months). Orelabrutinib demonstrated an excellent safety profile, with most TRAEs being Grade 1-2. The incidence of Grade=3 TRAEs was significantly lower in the orelabrutinib group than in the control group, and no treatment-related atrial fibrillation, major bleeding, or second primary malignancies were observed. Patients-reported quality of life (Qol) data indicated that the overall health status of the orelabrutinib group was superior to that of the control group. From cycle 16 onward, more patients had clinically meaningful improvement with orelabrutinib versus the control group, with the numerical difference increasing over time. Orelabrutinib has been approved for the first-line treatment of CLL/SLL in China and included in the National Reimbursement Drug List in 2025, benefiting more patients. Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia in adults. In the last few years, the advent of BTK inhibitors has revolutionized the treatment landscape of CLL/SLL, replacing highly intensive and toxic chemoimmunotherapy regimens as the standard-of-care. Signal Transduction and Targeted Therapy (STTT) is a Nature Portfolio journal, publishing original research, reviews, and clinical advances. The SCI impact factor released in June 2026 reached 81.2. Announcement • Jul 06
InnoCare Pharma Doses First Patient In Clinical Trial Of Novel CDH17 Targeted ADC ICP-B208 In China InnoCare Pharma announced that the first patient has been dosed in the clinical trial of novel CDH17 targeted ADC, ICP-B208, in China. Developed from InnoCare’s in-house ADC platform, ICP-B208 is a novel ADC comprising a humanized anti-CDH17 monoclonal antibody conjugated to a potent, in-house invented payload via a protease-cleavable linker. This design enables significantly enhanced tumor-killing effects with improved stability and safety. CDH17 is a calcium-dependent cell adhesion protein that plays a key role in tumor cell proliferation, migration, and metastasis. Its tumor-restricted expression and functional role in cancer biology make CDH17 an attractive and differentiated target for the ADC therapy, which can be developed for the treatment of gastrointestinal cancers, including colorectal, gastric, pancreatic ductal adenocarcinoma, and biliary tract cancer. Currently, there are no approved CDH17 targeted ADCs globally. Announcement • Jun 30
InnoCare Pharma Limited to Report First Half, 2026 Results on Aug 25, 2026 InnoCare Pharma Limited announced that they will report first half, 2026 results on Aug 25, 2026 Announcement • Jun 15
InnoCare Pharma Presents over 40 Clinical Studies of Orelabrutinib At EHA 2026 Congress InnoCare Pharma announced that over 40 clinical studies of the Company's novel BTK inhibitor orelabrutinib were presented at the European Hematology Association 2026 Congress. Clinical data on the efficacy and safety of orelabrutinib in treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma patients from the United States and Europe was released for the first time. A series of clinical studies on orelabrutinib covered multiple hematological malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, and primary central nervous system lymphoma. These findings further support the excellent efficacy and safety of orelabrutinib. This study is to evaluate the safety and efficacy of orelabrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma from the United States and Europe. Results are consistent with the prior report in Chinese patients, confirming the efficacy and safety of orelabrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma in a global population. In evaluable treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma patients (median follow-up 38.1 months), overall response rate was 100%, with 36-month progression-free survival rate at 94.4% and 36-month overall survival rate at 100% respectively. In evaluable relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma patients (median follow-up 36.8 months), overall response rate was 86.7%, with 36-month progression-free survival rate 77.9% and the 36-month overall survival rate 80.1% respectively. Orelabrutinib demonstrates high kinase selectivity, alleviates off-target inhibition, and reduces cardiovascular, bleeding, and hematologic adverse events. With long-term follow-up, orelabrutinib demonstrated rapid and durable responses, indicating sustained therapeutic benefit in patients with relapsed/refractory marginal zone lymphoma. Importantly, no new safety signals were observed during extended follow-up. At a median follow-up of 36.8 months, the investigator-assessed overall response rate was 58.9%, median progression-free survival was 44.4 months, and the 36-month overall survival rate was 84.7%. This is a prospective, phase II, multicenter study. The preliminary results demonstrated encouraging efficacy and a manageable safety profile in patients with previously untreated marginal zone lymphoma. Patients with an MZL-IPI score of 0–2 received obinutuzumab plus orelabrutinib (O2 regimen). Those with a score of 3–5 received obinutuzumab, orelabrutinib and lenalidomide (RO2 regimen). In patients who completed six cycles of induction therapy, the complete response rate was 85.7% and overall response rate was 95.3% in the O2 group, and the complete response rate was 71.4% and overall response rate was 85.7% in the RO2 group. The study is ongoing, and updated efficacy and safety data will be reported in due course. Results support the polatuzumab vedotin combined with orelabrutinib and rituximab (PRO regimen), which includes orelabrutinib, as a feasible strategy for vulnerable patients. Patients had a median age of 78 years. At the completion of combination therapy, the complete response rate was 91.7%. With a median follow-up of 7.0 months, neither the median progression-free survival nor the median overall survival has been reached. The estimated 9-month progression-free survival rate was 92.8%. Most other hematologic and non-hematologic toxicities were confined to Grade 1-2 and were clinically manageable with supportive care. This analysis aims to evaluate the efficacy of Bruton’s tyrosine kinase inhibitors like orelabrutinib plus high-dose methotrexate-based chemotherapy regimens as induction treatment for newly diagnosed primary central nervous system lymphoma patients in a real-world cohort. The results show that the overall response rate after induction treatment was 88.6% and the complete response rate was 81.1%. There was no significant difference in progression-free survival among the three Bruton’s tyrosine kinase inhibitors, but a significant improvement in overall survival was observed in the orelabrutinib group (hazard ratio 0.26, P = 0.016). These results support the use of Bruton’s tyrosine kinase inhibitor-containing treatment regimens as a first-line therapy for primary central nervous system lymphoma in clinical practice. More studies on orelabrutinib have been accepted for poster presentations at the 2026 European Hematology Association Congress. Additionally, more than 20 studies on orelabrutinib were selected for online presentation. Announcement • Jun 05
InnoCare Pharma Presents Phase IIb Study Results For Orelabrutinib In Systemic Lupus Erythematosus InnoCare Pharma announced that study results of its novel BTK inhibitor orelabrutinib in Phase IIb Study for systemic lupus erythematosus (SLE) were presented at the EULAR 2026 European Congress of Rheumatology in London. The Phase IIb clinical study of orelabrutinib for SLE met its primary and secondary endpoints, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. The study also showed that orelabrutinib can significantly reduce disease activity and Glucocorticoid (GC) dosage, and exhibited a favorable trend toward SLE relapse delay and biomarkers improvement. Orelabrutinib was safe and well tolerated in participants with SLE. The study aimed to evaluate the efficacy and safety of orelabrutinib in patients with moderate to severe SLE. A total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinib 75 mg once-daily (QD), orelabrutinib 50 mg QD, and placebo. The primary endpoint of this study was the SLE Response Index-4 (SRI-4) response rate at week 48. The secondary endpoints were the SLE Response Index-6 (SRI-6) and the British Isles Lupus Assessment Group (BILAG 2004)-based Composite Lupus Assessment (BICLA) Response at week 48. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p = 0.01 vs placebo), meeting the primary endpoint. At week 48, the orelabrutinib 75 mg QD group demonstrated higher SRI-6 and BICLA response rates compared to the placebo group (p < 0.05), meeting the secondary endpoints. 71.1% of patients in the 75 mg group achieved steroid reduction to =7.5 mg, compared with 43.6% in the placebo group. Mean cumulative corticosteroid exposure through 48 weeks was reduced by 301.0 mg in the 75 mg QD group versus placebo. Orelabrutinib was safe and well tolerated. The overall safety profile of TEAEs was consistent with previous studies, and no new safety signals were identified. The Company has been accelerating the patient enrollment of the registrational Phase III clinical trial of orelabrutinib for the treatment of SLE. Announcement • Jun 03
InnoCare Pharma Limited Releases Updated Data From Oral Presentation Of Mesutoclax In MDS And AML InnoCare Pharma Limited announced that updated data from the Company's novel BCL2 inhibitor mesutoclax in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) has been released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation titled “Safety, tolerability, and efficacy of mesutoclax (ICP-248) in combination with azacitidine in patients with myeloid malignancies”, demonstrating outstanding efficacy and safety. As of April 20, 2026, among evaluable treatment-naïve (TN) MDS patients, the overall response rate (ORR) per IWG 2006 criteria was 100%, including a complete response (CR) rate of 40%, and marrow CR rate of 60%. The composite CR rate was 90% per IWG 2023 criteria, including a CR rate of 60%. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi), and 86.5% were MRD (Minimal Residual Disease) negative. Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remissions. In the 125mg mesutoclax group, the 6-month duration of response (DOR) rate and overall survival (OS) rate were 93.3% and 90.5% respectively. In TN AML patients with TP53 mutations, the cCR rate was 71.4% and the 6-month DOR rate exceeded 50%. No dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Most non-hematologic adverse events were grade 1 or 2. Due to the robust efficacy of the regimen, patients achieved rapid cytopenia recovery. Among TN AML patients, the mortality rate was 0% at both 30 or 60 days. IWG criteria refers to International Working Group (IWG) response criteria in myelodysplasia. CRi refers to complete response with incomplete hematologic recovery. Announcement • May 28
InnoCare Pharma Announces Acceptance of New Drug Application for Orelabrutinib in Primary Immune Thrombocytopenia in China InnoCare Pharma announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with primary immune thrombocytopenia (ITP) in China. This marks the first NDA acceptance for orelabrutinib in the field of autoimmune diseases. ITP represents an important expansion of orelabrutinib beyond hematologic malignancies into autoimmune diseases. With its high target selectivity and a favorable safety profile, orelabrutinib is well positioned to become a preferred BTK inhibitor for the treatment of ITP. Currently, no BTK inhibitors have been approved in China for ITP. ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet counts, resulting in an increased risk of bruising and bleeding. With over 200,000 new cases globally each year, including 60,000 in China, ITP represents a significant unmet medical need. Orelabrutinib has demonstrated favorable efficacy and safety in the field of autoimmune diseases. In addition to ITP, Phase III registrational clinical trials for orelabrutinib in systemic lupus erythematosus (SLE), primary progressive multiple sclerosis (PPMS), and secondary progressive multiple sclerosis (SPMS) are currently underway in China and globally. Announcement • May 14
InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054 InnoCare Pharma announced that the first subject has been dosed in the Phase 1 trial of ICP-054 (ZB021), a novel potentially best-in-class oral IL-17AA/AF inhibitor. The Phase 1 trial is supported by robust preclinical data demonstrating a desirable pharmacology and toxicology profile. In addition to potent inhibition of IL-17AA/AF signaling, and anti-inflammatory activity demonstrated in preclinical animal models, excellent oral bioavailability was observed across multiple preclinical species, including non-human primates. Together, these data support the potential of ICP-054 to be a differentiated oral therapy for autoimmune and inflammatory diseases associated with dysregulated IL-17 signaling. The Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of single ascending doses (SAD) and multiple ascending doses (MAD) of ICP-054 in healthy volunteers and is being conducted in partnership with Zenas BioPharma in China. These data are expected by year-end 2026. Upon completion of the study, InnoCare plans to advance clinical development of ICP-054 to establish its proof-of-concept in the field of autoimmune diseases. ICP-054 is a novel potentially best-in-class oral small molecule IL-17AA/AF inhibitor being developed by InnoCare in partnership with Zenas BioPharma. ICP-054 is designed to selectively block the signal transduction pathways of both the IL-17AA homodimer and IL-17AF heterodimer, inhibiting downstream pro-inflammatory cytokine and chemokine release. Preclinical studies have demonstrated potent anti-inflammatory activity, a favorable safety profile, and excellent Absorption, Distribution, Metabolism, and Excretion (ADME) properties. The IL-17 pathway has demonstrated broad utility across many rheumatic and dermatologic indications. Currently, no oral IL-17 inhibitors have been approved or are in late-stage development globally. ICP-054's oral, small molecule profile may offer meaningful advantages over currently approved biologic IL-17 therapies in terms of convenience, compliance, and accessibility. Zenas BioPharma licensed the exclusive rights from InnoCare Pharma to develop, manufacture, and commercialize ICP-054 in all fields of use worldwide, excluding greater China and Southeast Asia. Announcement • May 10
InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In China InnoCare Pharma announced the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II clinical trial of its novel TYK2 inhibitor ICP-488 for the treatment of Sjögren's syndrome. ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the TYK2 JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. As Sjögren's syndrome is associated with the aberrant activation of TYK2 pathways, ICP-488 is expected to provide a novel therapeutic option for patients. Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphoproliferation and progressive exocrine gland injury. Its main clinical manifestations include salivary and lacrimal gland dysfunction, as well as multisystem and multi-organ involvement, which significantly impacts patients’ quality of life. In China, the prevalence of Sjögren's syndrome ranges from 0.33% to 0.77%, with an estimated population of 5 million. Currently, there are no approved targeted therapies for Sjögren's syndrome globally. Announcement • Apr 29
InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLE InnoCare Pharma announced that the first patient has been dosed in the registrational Phase III clinical trial of novel BTK inhibitor orelabrutinib for the treatment of systemic lupus erythematosus (SLE). This is a randomized, double-blind, placebo-controlled, multicenter Phase III study evaluating the efficacy and safety of orelabrutinib in patients with SLE, with the SRI-4 response rate at Week 52 as the primary endpoint. The Phase IIb clinical study of orelabrutinib met its primary endpoint, making orelabrutinib the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE. Under stringent steroid-tapering requirements, orelabrutinib 75 mg once daily (QD) achieved a statistically significant improvement in SLE Response Index-4 (SRI-4) rate compared with placebo at Week 48 (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. In a higher disease activity subgroup (BILAG =1A or =2B; SLEDAI-2K score =4), the 75 mg QD group achieved SRI-4 response rate of 68%, representing a 43% absolute improvement over placebo. Notably, 71.1% of patients in the 75 mg group achieved steroid reduction to =7.5 mg, compared with 43.6% in the placebo group. SLE is a systemic autoimmune disease that often leads to multi-organ damage, particularly affecting the kidneys, musculoskeletal system, nervous system, skin, blood, and respiratory systems, with nearly all organ systems potentially involved. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the "China SLE Development Report 2020", there are approximately 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management for years or even decades, resulting in huge unmet medical needs. Announcement • Apr 21
InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794 InnoCare Pharma presented preclinical data of its novel B7-H3 targeted ADC ICP-B794. The research results were presented in the form of a poster at the AACR Annual Meeting (Abstract Code: LB355). ICP-B794 is a B7-H3 targeted ADC with a novel linker-payload. It demonstrated potent anti-tumor activity in preclinical tumor models and a significantly larger safety window compared to similar drugs. A Phase I dose-escalation clinical trial is undergoing. ICP-B794, derived from the company's proprietary ADC platform, employing an irreversible connector, a highly hydrophilic linker and a novel and potent payload, resulted in significantly enhanced tumor-killing effects and improved stability and safety. ICP-B794 exhibited excellent drug-to-antibody ratio (DAR) value stability and low payload release in human plasma. In the in vitro cellular assays, ICP-B794 demonstrated significantly improved cell killing activity compared to similar drugs. It also demonstrated superior in vivo efficacy to B7H3-ADCs generated from other platforms, achieving therapeutic outcomes even at low dose. ICP-B794 has shown the potential to overcome the drug resistance of other B7-H3 ADCs. In terms of safety evaluation, results of the GLP toxicology study were highly encouraging, with a safety window exceeding 200 folds. Announcement • Mar 30
InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026 InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026 Announcement • Mar 16
InnoCare Pharma Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China InnoCare Pharma announced that the first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China and the second globally. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally. Degradation of VAV1 can effectively inhibit T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, thereby exerting anti-inflammatory and immunomodulatory effects and alleviating autoimmune and inflammatory pathological processes. Preclinical studies have shown that ICP-538 induces deep degradation of VAV1, leading to a significant reduction in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins. Announcement • Mar 02
InnoCare Pharma's Next-Generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in China InnoCare Pharma announced that its next generation TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), for the treatment of pediatric patients (aged 2 to 12) with solid tumors harboring NTRK gene fusions. Priority review is one of the key policies introduced by the CDE to accelerate drug approval. Zurletrectinib has also been included in the "SPARK Program" by the CDE, a pilot initiative to encourage the development of pediatric anti-tumor drugs. In December 2025, zurletrectinib received approval for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboringNTRK gene fusions in China. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinIB demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively. In October 2025, the data from the Phase I/II clinical trial of zurletrectinib for the treatment of pediatric and adolescent patients with advanced solid tumors were released at the Congress of International Society of Pediatric Oncology (SIOP) 2025 as an oral presentation. Zurletrectinib demonstrated a well-tolerated safety profile and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors. The results highlight zurletrectinib's strong potential as a next-generation therapy for NTRK/ROS 1-driven malignancies, with the ability to overcome resistance to first-generation TRK inhibitors. NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%. It is estimated that there are about 6,500 new cases of NTRK fusion-positive Solid tumors diagnosed in China each year. There are significant unmet clinical needs in this area due to the lack of effective treatment options. Announcement • Feb 26
InnoCare Pharma Announces Key Developments of Critical Clinical Studies InnoCare Pharma announced key clinical development progress, including the completion of patient enrollment of multiple Phase III registrational trials. The Company completed patient enrollment of a Phase III registrational clinical trial of BCL2 inhibitor mesutoclax (ICP-248) in combination with BTK inhibitor orelabrutinib for treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Mesutoclax is a novel, highly selective oral BCL2 inhibitor. BCL2 is an important regulatory protein in the adoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. The fixed-duration treatment of mesutoclax in combination with orelabrutinIB will provide deeper remission for treatment-naive CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naive CLL and treatment-naive CLL-SLL patients. In addition, InnoCare also accelerated the clinical development of two novel TYK2 inhibitors. The company has completed patient enrollment in the Phase III registrational trial of soficitinib (ICP-332) for the moderate to severe atopic dermatitis (AD) and in the Phase III registrational trials of ICP-488 for the treatment of psoriasis recently. These important milestones mark a crucial step forward in addressing the huge unmet needs in AD with soficitinib and in psoriasis with ICP-488. Meanwhile, InnoCare has also completed patient enrollment in the Phase II clinical trial of soficitinIB for the treatment of vitiligo. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including AD, vitiligo, prurigo nodularis, CSU, and psoriasis. ICP-488 is an oral, potent, and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction pathways of IL-23, IL-12, type 1 IFN, and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. Announcement • Feb 13
InnoCare Pharma Announces First Patient Dosed in the Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China InnoCare Pharma announced that the first patient has been dosed in the Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU). Currently, patient enrollment has been completed in the Phase III registrational clinical trial of soficitinib for the treatment of moderate to severe atopic dermatitis (AD), and in the Phase II clinical trial for the treatment of vitiligo. In addition, clinical trials of soficitinib For the treatment of psoriasis and nodular prurigo are also progressing rapidly. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases. Soficitinib blocks signaling pathways such as lL-4, IL-13, IL-31, and other cytokines that drive mast cell activation and inflammation, reducing itch and wheals in CSU. CSU is characterized by recurrent wheals and itch, with a disease course typically lasting two to five years, and in some patients, even exceeding five years. China has a large population of CSU patients, and the condition is prone to recurrent episodes. Intense nighttime itching can severely disrupt patients' daily lives. Long-term, systematic, and standardized treatment is therefore essential for disease control. There are approximately 50 million CSU patients worldwide, and the global CSU treatment market is expected to reach $3 billion in 20292. Announcement • Feb 10
Innocare Pharma Announces IND Approval to Initiate Clinical Trial of Vav1 Degrader Icp-538 in China InnoCare Pharma announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to conduct clinical trials of ICP-538, a VAV1-directed molecular glue degrader (MGD). This is the first VAV1 degrader approved to enter clinical trials in China and the second globally. ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors, for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of aternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. Currently, there are no approved VAV1-targeted therapies globally.egradation of VAV1 can effectively inhibit T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, thereby exerting anti-inflammatory and immunomodulatory effects and alleviating autoimmune and inflammatory pathological processes. Preclinical studies have shown that ICP-538 induces deep degradation of VAV1, leading to a significant reduction in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins. Announcement • Dec 26
InnoCare Pharma Limited to Report Fiscal Year 2025 Results on Mar 26, 2026 InnoCare Pharma Limited announced that they will report fiscal year 2025 results on Mar 26, 2026 Announcement • Dec 18
InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in China InnoCare Pharma announced the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct a Phase II/III clinical trial of novel TYK2 inhibitor soficitinib (ICP-332) for the treatment of chronic spontaneous urticaria (CSU). Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, CSU, and more. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases. Soficitinib blocks signaling pathways such as lL-4, IL-13, IL-31, and other cytokines that drive mast cell activation and inflammation, reducing itch and wheals in CSU. CSU is characterized by recurrent wheals and itch, with a disease course typically lasting two to five years, and in some patients, even exceeding five years. China has a large population of CSU patients, a condition that is prone to recurrent episodes. The intense nighttime itching severely disrupts daily life. Long-term, systemic, and standardized treatment is therefore essential for disease control. Announcement • Dec 17
InnoCare Pharma Announces Achievement of Primary Endpoint in Phase 2b Study of Orelabrutinib Zenas BioPharma Inc. announced that its partner, InnoCare Pharma announced the achievement of the primary endpoint in a Phase 2b study of orelabrutinib, a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor, in patients with Systemic Lupus Erythematosus (SLE). InnoCare also received approval from China's Center for Drug Evaluation (CDE) to conduct a Phase 3 regulatory clinical trial as InnoCare develops orelabrutinabrutinib for the treatment of SLE in China. Announcement • Dec 15
InnoCare Pharma Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial InnoCare Pharma announced that the phase IIb clinical study of novel BTK inhibitor orelabrutinib has met the primary endpoint in patients with systemic lupus erythematosus (SLE). InnoCare has also received approval from the Center for Drug Evaluation (CDE) to conduct a phase III registrational clinical trial. Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had received 48 weeks of treatment in the phase IIb study. A total of 187 patients were enrolled and randomized (1:1:1) into three groups: orelabrutinabrutinib 75 mg once-daily (QD), orelabrut inib 50 mg QD, and placebo. The primary endpoint of this study was the SLE Response Index-4 (SRI-4) response rate at week 48. At week 48, the orelabrutinIB 75 mg QD group achieved a statistically significant improvement in SRI-4 response rate compared with placebo (57.1% vs. 34.4%, p < 0.05), meeting the primary endpoint. Additionally, the efficacy of the orelabrut in QD group was better than that of the 50 mg QD group, indicating a dose-dependent improvement trend in efficacy. At week 48, theOrelabrutinib75 mg QD group demonstrated significantly higher SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates compared to the placebo group (p < 0.05), meeting the secondary endpoint. In the subgroup of patients with baseline BILAG 1A or 2B, the placebo-adjusted difference in SRI-4 response rates for orelabrutinbib 75 mg QD was 35%. In the subgroup of patients With baseline BILAG 1 A or 2B and a clinical SLEDAI-2K score 4, the placebo-adjusted difference InnoCare-4 response rate for orelabrut InnoCare. The study showed that orelabrutin Fib was well tolerated in SLE patients. The safety profile was consistent with the mechanism of action of BTK inhibition and the underlying disease biology of SLE. Orelabrut inib is the first BTK inhibitor to demonstrate significant efficacy in a phase II clinical trial for SLE. Phase IIa clinical data on orelabrutinip for SLE was previously presented as a late breaking oral presentation at the European Union Congress of Rheumatology (EULAR). OrelabrutinIB is expected to become a first-in-class oral BTK inhibitor for the treatment of SLE. SLE is a systemic autoimmune disease that often leads to damage to multiple organs, particularly the kidneys and musculoskeletal system, nervous system, skin, blood system, and respiratory system; almost all systems can be affected. According to Frost & Sullivan, there are approximately 8 million people with SLE worldwide. According to the "China SLE Development Report 2020", there are approximately 1 million SLE patients in China, ranking first globally in total number and second in incidence rate. Most SLE patients are young and middle-aged women, requiring long-term management for years or even decades, resulting in huge unmet medical needs. Announcement • Dec 11
InnoCare Pharma Announces Approval of the Next-Generation TRK Inhibitor zurletrectinib in China InnoCare Pharma announced that its next-generation TRK inhibitor, zurletrectinib (ICP-723), has received approval from the China National Medical Products Administration (NMPA) for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurlet rectinib demonstrated outstanding efficacy and a favorable safety profile. The study results showed an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, and 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively. As a next-generation TRK inhibitor., zurletrectinib demonstrated superior efficacy compared to first-generation TRK inhibitors. It delivered durable deep remissions and exhibits strong brain penetration activity with a good safety profile. Moreover, it was also shown to overcome acquired resistance to the first-generation TRK inhibitor. The once-daily, two-tablet oral dosing has brought great convenience to patients. Zurletrectinib has demonstrated remarkable efficacy, particularly in achieving an ORR of 100% in adolescent patients. Clinically, zurletrect inib responds faster than traditional chemotherapy, with many patients showing substantial tumor shrinkage within one or two treatment cycles, providing a critical therapeutic window for patients in critical conditions. From a molecular mechanism perspective, the unique structure of zurletrectinib allows it to cross the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing new treatment options for patients with brain metastases. Announcement • Dec 10
InnoCare Pharma Announces over 20 Studies of its Novel BTK Inhibitor Orelabrutinib Presented at the 67th Annual Meeting of the American Society of Hematology InnoCare Pharma announced that over 20 studies of its novel BTK inhibitor orelabrutinib were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Mid-treatment CSF ctdna and MYD88 clearance outperform PET-CT in predicting response and survival toorelabrutinib-based induction in newly diagnosed PCNSL: A prospective biomarker study (Publication No.: 59). The orelabrutinabrutinib, rituximab, and high-dose methotrexate (ORM) induction is effective and well tolerated in newly diagnosed PCNSL. Preliminary study results of orelabrut in combination with rituximab for treatment-Naive marginal zone lymphoma: A prospective single-arm clinical trial (Publication No.: 3580). Orelabrutinib combined with rituximab demonstrates promising preliminary efficacy in treatment-naive MZL patients who failed or were unsuitable for local therapy, with an ORR of 81.8% and a CRR of 72.7%. Updated survival and safety data will be presented. The other studies selected for poster presentation are as follows: Efficacy and safety of orelabrutinIB, obinutuzumab, and lenalidomide in previously untreated marginal zone lymphoma: Preliminary results from a prospective, single-arm, multicenter, Phase II study (Publication No.: 5383). Orelabrut in bendamustine-rituximab or obinutuzumab followed by orelabrutinbib maintenance in untreated marginal zone lymphoma (Optimize): A multicenter, single-arm, phase II study (Publication No: 3596). Real-world efficacy and safety of orelabRutinib-based regimens in the treatment of marginal zone lymphoma (Publication No.: 1817) Single-cell transcriptomic profiling reveals tumor-intrinsic heterogeneity and immunemicro environment dynamics in the order trial for mantle-cell lymphoma (Publication No: 1792) Orelabrut in first-line treatment of diffuse large Bcell lymphoma with high-risk CNS-IPI (Publication No.: 5460) Preliminary result of first-line orelabrutinim plus R-CHOP in CD5-positive diffuse large B-cell lymphoma (Rocket trial): A single-arm, phase II trial (Publication No.: 3690). Exploration of optimal high-dose methotrexated-based therapy for patients with primary CNS lymphoma: A real-world study in China (Publication No.: 3693) Chemotherapy-free induction with pomalidomide, orelabrutinob, and rituximab (POR) followed by high-dose methotrexate,rituximab and orelabrutinin (ROM) in newly diagnosed primary CNS lymphoma: Interim analysis of a phase II study (Publication no.: 5471). Orelabrut Inib plus anti-PD-1 antibody and fotemustine for newly diagnosed primary central nervous system lymphoma: Phase I/II results (Publication No.: 5465) OrelabrutinabRutinib, ritiximab, and thiotepa (ORT) in combination with or without high-dose methotrexates in untreated primary central nervous system lymphoma (Publication No): 1911). Primary efficacy and safety of first-line R-MTO regimen (rituximab, methotrexate, thiotepa, andorelabrutinib) followed by autologous hematopoietic stem cell transplantation in PCNSL (Publication No.: 3687) Orelabrut InnoCare No.: 3687) O Relabrutinib, sintilimabrutinib, and temozolomide (Publication No.: 35 80). Announcement • Dec 09
InnoCare Pharma Announces Latest Data of InnoCare's Novel BCL2 Inhibitor Presented at the 67th Annual Meeting of the American Society of Hematology (ASH) InnoCare Pharma announced that three studies of its novel BCL2 inhibitor, Mesutoclax (ICP-248), were presented at the 67th Annual Meeting of the American Society of Hematology (ASH). Mesutoclax demonstrated remarkable efficacy and a favorable safety profile in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and acute myeloid leukemia (AML). The study of mesutoclax in the treatment of relapsed andrefractory MCL was selected for oral presentation, while the CLL/SLL and AML studies were chosen for poster presentations. The clinical data from mesutoclax (ICP -248) monotherapy demonstrated potential best in class efficacy in MCL patients, particularly in heavily treated patients with BTK inhibitors refractory. The overall response rate (ORR) of MCL patients treated with 125 mg mesutoclax monotherapy was 87.5%, with a complete response rate (CRR) of 46.9%. Among MCL patients who were BTK inhibitor refractory, the ORR was 84.0% and the CRR was 36.0%. Mesutoclax was well tolerated through all dose levels (50-150mg), with no dose-limiting toxicities (DLTs) observed, and maximum tolerated dose (MTD) not reached. The clinical data of mesutoclax monotherapy showed promising safety and potential Best-in-class efficacy in MCL patients, especially for those who had received multiple prior treatments and were resistant to BTK inhibitors. Mesutoclax monotherapy or in combination with orelabrutinib demonstrated a tolerable safety profile across all dose levels tested. 82.6% of the patients achieved uMR. Most CR+CRi in TN AML was achieved by the end of cycle 1. Notably, 44% of the treatment naive AML were classified as adverse risk group and median age is 68 years old. The combination of mesutoclax and AZA also demonstrated well tolerated safety profile. There is no DLT or TLS events during the whole study. The mortality rate within 90 days was 0%. Mesutoclax further strengthens InnoCare's pipeline of hematologic oncology products. Two registrational clinical trials are ongoing: one is the combination of mesutoclax & orelabrutinIB for the treatment of TN CLL/SLL; the other is for the treatment of MCL that is refractory to BTK inhibitors. In addition, the clinical study of mesutoclax as first-line treatment for AML has entered the dose expansion phase in China and globally, and the clinical study for the treatment of myelodysplastic syndrome (MDS) is being launched globally. Announcement • Nov 28
InnoCare Pharma Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo Nodularis InnoCare Pharma announced that the first patient has been dosed in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with prurigo nodularis in China. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The Current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, urticaria, and more. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases. Prurigo nodularis is a chronic inflammatory skin disease characterized by severe itching and skin nodules, which significantly impairs patients' quality of life. Soficitinib alleviates symptoms by blocking the signaling pathways of cytokines related to itching and inflammation, such as IL-4, IL-13, and IL-31, thereby reducing neurogenic itch responses and inhibiting skin inflammation. Announcement • Nov 01
InnoCare Pharma Announces First Patient Dosed in Clinical Trial of Novel ADC ICP-B794 in China InnoCare Pharma announced that the first patient has been dosed in the clinical trial of its novel B7-H3 targeted ADC, ICP-B794, in China. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer,esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. ICP-B794 has demonstrated superior anti-tumor activity in animal models compared with other ADCs, and exhibited significant tumor-killing effects even in large tumors. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed across multiple solid tumor types. Due to its tumor-specific expression, it is considered a highly promising anti-tumor target. The ADC platform developed by InnoCare is positioned to target hard-to-treat cancers. Through its innovated platform technology, it can achieve stronger tumor killing effects and a better safety profile when developing novel ADC drugs, which will offer better treatment option for cancer patients globally. Announcement • Oct 30
InnoCare Pharma Releases Latest Data of its Next Generation Pan-TRK Inhibitor Zurletrectinib for the Treatment of Pediatric and Adolescent Patients with Advanced Solid Tumors InnoCare Pharma announced that the latest data of its next generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of pediatric and adolescent patients with advanced solid tumors. The data from the phase I/II clinical trial has been released at the Congress of International Society of Paediatric Oncology (SIOP) 2025 as an oral presentation. In this study, zurletrectinib demonstrated favorable/well-tolerated safety and promising antitumor activity in pediatric/adolescent patients with NTRK/ROS1-altered solid tumors, The results/data highlight zurletrectinib's strong potential as a next-generation therapy for NTRK/ROS 1-driven malignancies, with the ability to overcoming resistance to first-generation TRK inhibitors. The predominant tumor types included NTRK-rearranged spindle cell tumors and primary central nervous system tumors. The Recommended Phase 2 Dose (RP2D) was determined to be 7.2 mg/m2 for pediatric patients and 8 mg for adolescents. Pharmacokinetic (PK) profiles at the RP2D showed comparable exposer levels between pediatric/adolescent and adult patients. As of July 31, 2025, the objective response rate (ORR) was 90% in NTRK fusion patients, as assessed by the Independent Review Committee (IRC). Among the patients who completed full efficacy evaluations, all of those who were resistant to first-generation TRK inhibitor achieved partial responses. No dose-limiting toxicities were observed. Treatment related adverse events (TRAEs) were predominantly grade 1 to2, indicating a favorable safety profile. Announcement • Sep 30
InnoCare Pharma Limited to Report Q3, 2025 Results on Nov 14, 2025 InnoCare Pharma Limited announced that they will report Q3, 2025 results on Nov 14, 2025 Announcement • Sep 08
InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore InnoCare Pharma announced that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL). Orelabrutinib is a novel BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy. Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with R/R MZL lack effective treatment options. In April 2025, orelabrutinib received approval in China for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL). Orelabrutinib has been also approved for the treatment of three other indications in China, including relapsed and refractory (R/R) CLL/SLL, r/r mantle cell lymphoma (R/R MCL) and r/r marginal zone lymphoma (R/R MZL), all of which have been covered in China’s National Reimbursement Drug List. Announcement • Jul 04
InnoCare Pharma Announces Approval of Clinical Trial of A Novel ADC ICP-B794 in China InnoCare Pharma announced the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of a novel B7-H3 targeted ADC ICP-B794. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target. With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare's proprietary ADC technology platform, alongside promising precision medicine candidates like TRK inhibitor zurletrectinib (ICP-723), positions the Company to establish a strong presence in the field of solid tumor treatment. Announcement • Jul 03
InnoCare Pharma Limited to Report First Half, 2025 Results on Aug 20, 2025 InnoCare Pharma Limited announced that they will report first half, 2025 results on Aug 20, 2025 Announcement • Jun 13
Data of InnoCare's Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress latest data of InnoCare's robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported. Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by OrelabrutinIB Maintenance in untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898) The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. Updated outcomes on efficacy, safety, and biomarker analysis will be reported. Pomalidomide, Rituximab, Orelabrutinabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No: PF950) The results further support Pomalidomide, R ituximab, O Relabrutinib, & MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to theomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy. A total of 32 patients were enrolled in this study, of whom 26 patients completed 3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively. Announcement • Jun 03
InnoCare Announces Latest Data of Robust Oncology Pipelines Presented at the 2025 ASCO Annual Meeting InnoCare's robust oncology pipelines were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, involving the anti-CCR8 antibody ICP-B05 (CM369), the BCL2 inhibitor mesutoclax (ICP-248) and the pan-TRK inhibitor zurletrectinib (ICP-723). The current study is the first and only report on the preliminary efficacy data of anti-CCR8 targeted therapy for CTCL patients. The efficacy of ICP-B05 was supported by the PD effects in both skin lesions and peripheral blood in the depletion of CCR8+ cells. ICP-B05 is safe and well tolerated and its safety profile made it a good candidate for combo therapies for CTCL patients with lymph node and other organ involvement. As of Jan. 6, 2025, a total of 13 patients with R/R CTCL were treated. There were 12 patients received at least one skin lesion assessment followed the mSWAT. 33.3% of patients achieved PR, and 58.3% of patients were assessed as SD with reduction in skin lesion. The 6-month PFS rate was 82.5%, and the median PFS was 11.4 months. Among the five patients with CCR8+ levels exceeding 10%, four (80%) achieved PR. PK analysis showed that serum exposure (Cmax and AUC0-14D) increased with dose escalation. PD analysis demonstrated significant depletion of CTCL-expressing cells in CTCL skin lesions. In line with previously reported results, zurletrectinib continued to demonstrate a deep and durable responses in adult patients with NTRK+ advanced solid tumors with or without brain metastasis. Zurletrectinib was also well-tolerated and showed favorable safety profile in adult patients with various tumor types. As of Nov. 23, 2024, a total of 49 TRK inhibitor naive adult patients were evaluable for efficacy representing 12 different solid tumor types. Among the efficacy population, the distribution of NTRK1, NTRK2 and NTRK3usions was 53.1%, 2.0% and 44.9% respectively. The confirmed ORR by IRC was 83.7%, with CR of 10.2%. Median duration of response (DOR) and median progression-free survival (PFS) by IRC were not reached. The DOR rate and PFS rate by IRC at 12 months was 92.0% and 90.5% respectively. Two of the three patients who had brain metastasis at the baseline achieved intracranial ORR, which is consistent with the good brain penetration and strong intracranial activity of zurletrectinib. The 2025 ASCO Annual Meeting is held from May 30 to June 3, 2025 in Chicago, U.S. The ASCO annual meeting is the most important and professional academic event in the global oncology field, which showcases the international cutting-edge clinical oncology research results and tumor treatment technologies. Announcement • May 29
InnoCare Pharma Announces Approval of Clinical Trial of BCL2 Inhibitor Mesutoclax for Myelodysplastic Syndromes in China InnoCare Pharma announced the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndromes (MDS). Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China. The Company is accelerating patient enrollment of a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as a clinical trial of mesutoclax for the treatment of acute myeloid leukemia (AML). Announcement • May 21
Innocare Announces the Approval of Minjuvi®? (Tafasitamab) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China InnoCare Pharma announced that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi®? (tafasitamab), a humanized Fc- modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidOMide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo'ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomides have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamib is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), anditionally approved by the European Medicines Agency (EMA), in combination with lenalidomIDE for the treatment of relapsed and refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases1. Tafasitamamab is a humanized Fc- modify cytolytic CD19 targeted monoclonal antibody. Tafasitam ab is a humanized Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tAFasitamab globally. In August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamib in hematology and oncology in Greater China. In the United States, Monjuvi®? (tAFasitamab-cxix) received accelerated approval by the U. S. Food and Drug Administration (FDA), and previously approved by the European Medicines agency (EMA), in combination withlenalidomide for the treatment of relapsedor refractory DLBCL adults patients who are not eligible for AsCT. DLBCL is The most common type of non- Hodgkin lymphoma (NHL), and its incidence accounts For 31% to 34% to 34% of NHL worldwide. In China, DLBC Lymphoma (DLBCL accounts for 45. 8% of all NHL cases. Announcement • May 16
InnoCare Pharma Announces First Patient Dosed in the Phase II/IIII Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Vitiligo in China InnoCare Pharma announced that the first patient has been dosed in the Phase II/III clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with non-segmental vitiligo in China. Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders, including vitiligo, atopic dermatitis (AD), prurigo nodularis, etc., with broad market potential. TYK2 is a non-receptor tyrosine kinase and a member of the JAK kinase family. It plays a key role in the JAK-STAT signaling pathway and is critically involved in the pathogenesis of inflammatory diseases. Vitiligo happens when skin melanocytes are destroyed, leading to loss of pigment, and leaving white patches on the skin. Vitiligo affects approximately 0.5%-2%1 of the global population. It is a chronic condition that requires long-term treatment. The goals of therapy include disease stabilization, repigmentation, and maintenance treatment to prevent recurrence of depigmentation. In addition to vitiligo, the clinical development of soficitinib for other autoimmune diseases is also progressing, including the Phase III registrational trial for atopic dermatitis. Announcement • May 12
InnoCare Pharma's Mesutoclax Receives Breakthrough Therapy Designation from China's NMPA InnoCare Pharma announced that its B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China! Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin's lymphomas (NHLs), and as well as acute myeloid leukemia (AML). BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Clinical trials of mesutoclax are ongoing both in China and globally, including a Phase III registrational trial of mesutoclax in combination with orelabRutinib as a first line therapy for the treatment of CLL/SLL patients, as well as a clinical trial of mesutoclax for the treatment of AML. The Breakthrough Therapy Designation (BTD) by the CDE aims to accelerate the clinical development of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials. Announcement • May 02
Innocare Pharma's Zurletrectinib Receives Priority Review from China's Nmpa InnoCare Pharma announced that its new generation pan-TRK inhibitor zurletrectinib (ICP-723) has been granted priority review by the Center for Drug Evaluation of the China National Medical Products Administration, which accepted the New Drug Application of zurletrectinib for the treatment of patients with advanced solid tumors harboring NTRK gene fusions recently. Priority review is one of the key policies introduced by the CDE to accelerate drug approval. In the registrational trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Announcement • Apr 25
Innocare Pharma Announces Approval of Orelabrutinib for the First-Line Treatment of Cll/Sll in China InnoCare Pharma announced that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL). The approval of the first-line CLL/SLL treatment will enable orelabrutinabrutinib to benefit an even broader population of lymphoma patients. Orelabrutinib has been approved for the treatment of three indications in China, including relapsed and refractory (R/R) CLL/SLL, r/r mantle cell lymphoma (R/R MCL) and r/r marginal zone lymphoma (R/R MZL), all of which have been covered in the National Reimbursement Drug List. Announcement • Apr 16
InnoCare Pharma Announces the Acceptance of New Drug Application for Pan-TRK Inhibitor Zurletrectinib in China InnoCare Pharma announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a New Drug Application (NDA) for its new generation pan-TRK inhibitor zurletrectinib (ICP-723) for the treatment of adult and adolescent patients (12 to 18 years old) with advanced solid tumors harboring NTRK gene fusions. In the registrational trial for adult and adolescent patients with NTRK fusion-positive solid tumors, zurletrectinib demonstrated outstanding efficacy with a good safety profile. Zurletrectinib was also shown to overcome acquired resistance to the first-generation TRK inhibitors. Meanwhile, the Company is accelerating the registrational trial for pediatric patients (2 to 12 years old). NTRK fusion genes occur in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland carcinoma, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK gene fusion exceeds 90%. It is estimated that there are about 6,500 new cases of NTRK fusion-positive Solid tumors are diagnosed, in China each year. There are highly unmet clinical needs in this area due to lack of effective treatment options. Announcement • Mar 27
InnoCare Pharma Limited, Annual General Meeting, Jun 20, 2025 InnoCare Pharma Limited, Annual General Meeting, Jun 20, 2025. Announcement • Mar 20
InnoCare Pharma Announces First Patient Dosed in the Phase III Registrational Trial of ICP-488 for the Treatment of Psoriasis in China InnoCare Pharma announced that the first patient has been dosed in the Phase III registrational trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-488, for the treatment of moderate-to-severe plaque psoriasis in China. This is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study, designed to evaluate the efficacy and safety of ICP-488 monotherapy in adult patients with moderate-to-severe plaque Psoriasis. ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines, thereby inhibiting the pathological processes of autoimmune and inflammatory diseases. According to the data presented at the Late-breaking Research session of the 2025 American Academy of Dermatology (AAD) Annual Meeting, the Phase II study results demonstrated that ICP-488 is highly effective in treating psoriasis at both 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for patients with moderate-to- severe psoriasis. Announcement • Mar 10
InnoCare Pharma Limited Announces Presentation of ICP-488 Phase II Clinical Data for Moderate-To-Severe Plaque Psoriasis at 2025 AAD Annual Meeting InnoCare Pharma Limited announced that the data from phase II study of ICP-488 for the treatment of moderate-to-severe plaque psoriasis has been presented at the 2025 American Academy of Dermatology Annual Meeting, the most influential international event in dermatology, as a late-breaking oral presentation. Efficacy and Safety of a Highly Selective Oral TYK2 Inhibitor, ICP-488, in Patients with moderate-to-Severe Plaque Psoriasis: A Phase II, Randomized, Double-blinded, Placebo-Controlled Trial (S040, Late-Breaking Research: Session 2). The study results demonstrated that ICP-488 is highly effective in treating psoriasis patients at both 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients. A total of 129 psoriasis patients were randomized into three groups to receive once daily oral doses of ICP-488 at 6 mg, 9 mg, or placebo for twelve weeks. The primary endpoint was the percentage of subjects who achieved at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI 75) at week 12. At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%) (P<0.0001); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-4886 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%) (P<0.001). All treatment emergent adverse events and treatment-related adverse events and were mild or moderate. Announcement • Feb 26
InnoCare Pharma Limited Announces Release of Phase II Results of Orelabrutinib for the Treatment of Relapsing-Remitting Multiple Sclerosis At 2025 ACTRIMS Forum InnoCare Pharma announced that the phase II results of orelabrutinib for the treatment of relapsing-remitting multiple sclerosis (RRMS) was released at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, which will be also presented as the on-site poster on Feb. 27 U.S. Eastern Time. The Forum is held from February 27 to March 1 in West Palm Beach, Florida of the United States. As a premier global event in neuroimmunology, ACTRIMS gathered scholars and experts specializing in neuroimmunology from around the world to jointly explore the cutting-edge developments in multiple sclerosis and related disorders. Positive Phase 2 Results of Orelabrutinib in Patients with Relapsing-Remitting Multiple Sclerosis: Orelabrutinib was shown to be highly effective for the treatment of relapsing-remitting multiple sclerosis (RRMS) patients. The 80 mg once daily (QD) dose showed the best efficacy and safety profile, thus being selected for phase III progressive MS studies. In this double-blind, phase II trial, 158 eligible RRMS subjects were randomized in a 1:1:1:1 ratio to one of four treatment groups: placebo, orelabrutinib 50 mg QD, orelabrutinib 80 mg QD, and orelabrutinib 50 mg twice daily (BID). The subjects in the placebo group were switched to orelabrutinib 50 mg QD at Week 13. The primary endpoint was the cumulative number of new gadolinium-enhancing (Gd+) T1 brain lesions at Week 12 (based on Gd+ T1 lesions at Weeks 4, 8, and 12) compared to placebo. At Week 12, all three treatment groups showed statistically significant reductions in the cumulative number of new Gd+ T1 lesions and new/enlarging T2 lesions compared to the placebo group (p < 0.05), while the 80 mg QD and 50 mg BID groups showed statistically significant reductions throughout 24 weeks compared to the placebo/50 mg QD group (p < 0.05). The 80 mg QD group demonstrated the highest reductions of 90.4% at Week 12 compared to placebo and 92.3% at Week 24 compared to the placebo/50 mg QD group. The new lesion control by each orelabrutinib group occurred at the earliest assessment timepoint of 4 weeks and was sustained throughout 24 weeks. BTK regulates the functions of B cells and myeloid cells, which are implicated in the pathogenesis of MS. Orelabrutinib is a highly selective, brain-penetrant BTK inhibitor that not only inhibits B cell and macrophage activation peripherally, but also inhibits B cell, microglia, and macrophage activation in the central nervous system. Announcement • Feb 17
InnoCare Pharma Limited Announces Approval of Registrational Phase III Study of B-Cell Lymphoma-2 Inhibitor Icp-248 (Mesutoclax) in Combination with Orelabrutinib as First-Line Therapy for Treatment of Cll/Sll Patients in China The board of directors of InnoCare Pharma Limited announced the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the registrational Phase III clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with BTK inhibitor Orelabrutinib as a first-line (1L) therapy for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients in China. ICP-248 (MESutoclax) is a novel, orally bioavailable BCL2-selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. ICP-248 (Mesutoclax) exerts anti-tumor activity by selectively inhibiting BCL2 protein and restoring the normal apoptosis process in cancer cells. The fixed-duration treatment of ICP-248 (Melabrutinib will provide deeper remission for treatment-naive CLL/SLL patients without drug-resistant mutations, bringing hope of clinical cure to treatment-naive CLL-SLL patients and becoming a treatment option with considerable potential. ICP- 248 (Mesutoclax), has demonstrated promising efficacy and a favorable safety profile in Phase II trial in treatment-naive CLL /SLL patients. Market approval of the combination therapy will provide better treatment options for treatment-naive Cll/SLL patients. The Company is rapidly advancing multiple clinical trials of ICP-248 (mesutoclax) globally, including the treatment of non-Hodgkin's lymphoma (NHL), and acute myeloid leukemia (AML). hemato-oncology pipeline is designed for strong synergy, especially with the combination of BTK inhibitors and BCL2 inhibitors, which has the potential to deliver improved outcomes for patients. Announcement • Jan 21
InnoCare Pharma Limited Appoints Kunliang Guan as an Independent Non-Executive Director The board of directors of InnoCare Pharma Limited announced that Prof. Kunliang Guan has been appointed as an independent non-executive Director with effect from January 21, 2025. Prof. Guan is primarily responsible for supervising and providing independent judgement to the Board. Prof. Guan, aged 61, has been serving as a chair professor and Ph.D. mentor of School of Life Sciences at Westlake University since August 2023. Prof. Guan was a faculty at the University of Michigan between May 1992 to September 2007; served at University of California San Diego from October 2007 to June 2023 (Distinguished Professor from July 2013). Prof. Guan has been studying signal transduction in cell growth regulation and tumorigenesis for over thirty years. As a postdoctoral fellow, Prof. Guan discovered the dual specific protein phosphatase family and a novel thio-phosphate intermediate in biocatalysis. Early works from his laboratory led to the cloning of human MEK1/2 and elucidation of the mechanism of MEK activation. Over the last twenty years, Prof. Guan's group has been studying mTOR and Hippo pathways. Prof. Guan's group has made major contributions to the establishment of the mTORC1 signaling network, including identification of TSC1/2-Rheb, Rag, and AMPK as mTORC1 upstream regulators in response to growth factor, nutrient, and energy, respectively, as well as elucidation of ULK1 and VPS34 as downstream effectors of mTORC1 in autophagy. As such, Prof. Guan is the second most cited investigator in the mTOR field. Recently, Prof. Guan's group has been focusing on the Hippo pathway and its role in cancer. The group has been playing a leading role in advancing the Hippo field as Prof. Guan is the most cited investigator in the Hippo field. Prof. Guan have co-authored over 300 research papers and is one of the most highly cited researchers in molecular biology and genetics (with over 150,000 academic citations and an h-index of 179). Professor Guan's group's future research will focus on molecular mechanisms of cellular regulation, upstream signals, physiological functions, and their roles in cancer. Prof. Guan received his bachelor's degree in biology from Zhejiang University (formerly Hangzhou University) in June 1982 and his Ph.D. in biochemistry from Purdue University in December 1989; from December 1989 to September 1991, Prof. Guan conducted postdoctoral research on biochemistry at Purdue University. Prof. Guan's appointment was recommended by the nomination committee of the Board after taking into account his current and previous work experience, professional qualification, and his expected devotion to the Company in terms of time and effort. The Board is satisfied that Prof. Guan is of such character, integrity and experience commensurating with the office of an independent non-executive Director. Announcement • Dec 27
InnoCare Pharma Limited to Report Fiscal Year 2024 Results on Mar 28, 2025 InnoCare Pharma Limited announced that they will report fiscal year 2024 results on Mar 28, 2025 Announcement • Oct 10
InnoCare Pharma Limited Announces Phase II Clinical Study of Icp-488 for the Treatment of Moderate-To-Severe Plaque Psoriasis InnoCare Pharma Limited announce the positive results from the phase II randomized, double-blind, placebo-controlled study of ICP-488, a once-daily oral TYK2 (tyrosine kinase 2) allosteric inhibitor, in patients with moderate-to- severe plaque psoriasis. ICP-488 is a potent and highly selective TYK2 allosteric inhibitor. By binding the TYK2- JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. The phase II study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ICP-488 in patients with moderate to severe plaque psoriasis. The primary endpoint of the study was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index score (PASI 75 response) at week 12. Study results demonstrated a significant improvement in PASI 75 at week 12 for patients receiving both 6mg and 9mg (QD) of ICP-488, compared to patients receiving placebo. Additionally, a statistically significant greater proportion of patients also reached PASI 90, PASI 100 and static Physician Global Assessment (sPGA) scores of 0/1 in the ICP-488 dosing arms compared to placebo. · A significantly greater proportion of patients treated with ICP-488 for 12 weeks achieved PASI 75 (77.3%, 78.6%; 6mg, 9mg, respectively) versus placebo (11.6%; p<0.0001), meeting the study's primary endpoint. · A significantly greater proportion of patients treated with ICP-488 for 12 weeks achieved PASI 90 (36.4%, 50.0%; 6mg, 9mg, respectively) versus placebo (0%; p<0.0001), and PASI 100 (11.4%, 11.9%; 6mg, 9mg, respectively) versus placebo (0%; p<0.05). · A significantly greater proportion of ICP-488 treated patients achieved sPGA scores of 0/1 (70.5%, 71.4%; 6mg, 9mg, respectively) versus placebo (9.3%; p<0.0001) at 12 weeks. A sPGA score of 1 indicates almost clear skin and 0 indicates totally clear skin. In this study, most treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were mild or moderate in severity and self-limited. The Company will continue to evaluate the potential of ICP-488 in patients with plaque psoriasis in phase III study while also exploring its application in other autoimmune diseases. Announcement • Oct 09
InnoCare Pharma Announces Phase II Study Results of TYK2 Inhibitor ICP-488 Meet Primary Endpoint in Psoriasis Patients InnoCare Pharma announced that phase II clinical study results of novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-488 met the primary endpoint in adult patients with moderate-to-severe plaque psoriasis. ICP-488, in psoriasis patients treated for 12 weeks, demonstrated an excellent efficacy and safety profile. ICP-488 achieved multiple efficacy endpoints including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (improvement of at least 75%, 90% and 100% in PASI score from baseline) and static Physician’s Global Assessment (sPGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) in both the 6mg and 8mg dosing group respectively. Following the 12-week treatment with 6mg or 9mg once-daily dosing of ICP-488, PASI 75 reached 77.3% and 78.6% respectively, compared to 11.6% for patients receiving placebo (p<0.0001); PASI 90 reached 36.4% and 50.0% respectively, compared to 0% for patients receiving placebo (p<0.0001); PASI 100 reached 11.4% and 11.9% respectively, compared to 0% for patients receiving placebo (p<0.05); sPGA 0/1 reached 70.5% and 71.4% respectively, compared to 9.3% for patients receiving placebo (p<0.0001). ICP-488 demonstrated good tolerability and a favorable safety profile, with most treatment emergent adverse events (TEREs) and treatment-related adverse events (TRAEs) being mild or moderate. This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment. ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding to the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. Recent data indicates that approximately seven million people in China are currently living with psoriasis1, and this number is on the rise2. Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications. Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether. Announcement • Sep 30
InnoCare Pharma Limited to Report Q3, 2024 Results on Nov 12, 2024 InnoCare Pharma Limited announced that they will report Q3, 2024 results on Nov 12, 2024 Announcement • Sep 25
InnoCare Pharma Limited Announces Board and Committee Changes InnoCare Pharma Limited announced that Mr. Ming Jin (Mr. Jin) has tendered his resignation as a non-executive director with effect from 25 September 2024, to devote more time on his primary responsibilities as a partner in Beijing Hankang Venture Capital Management Co. Ltd. The board also announced that Dr. Kaixian Chen (Dr. Chen) has tendered his resignation as an independent non-executive director, a member of each of the audit committee (the Audit Committee), the compensation committee (the Compensation Committee) and the nomination committee (Nomination Committee) of the board with effect from 25 September 2024, as he needs more time for his dedication in academic research as an academician of the Chinese Academy of Sciences. The board further announced that, concurrent with the resignation of Dr. Chen as a member of each of the Audit Committee, the Compensation Committee and the Nomination Committee, Dr. Dandan Dong, an independent non-executive Director, has been appointed as a member of each of the Audit Committee, the Compensation Committee and the Nomination Committee. Following the resignation of Dr. Chen, the company has in place two independent non-executive Directors, which results in the need for the Company to fulfil the minimum number of independent non-executive Directors required under Rule 3.10(1) of the Rules Governing the Listing of Securities on the Stock Exchange (the Listing Rules) within three months from the date of resignation of Dr. Chen. Announcement • Sep 19
InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 for Acute Myeloid Leukemia in China InnoCare Pharma announced the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China. Acute myeloid leukemia (AML) is a malignant hematological disease originating from hematopoietic stem/progenitor cells, accounting for about 80% of acute leukemia in adults. The risk of developing AML increases with age and is more common in middle-aged and elderly people. AML is also not uncommon in individuals under 18 years old, representing about 15-20% of pediatric leukemia and 80% of leukemia in neonates and infants. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. It has anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. Announcement • Sep 10
InnoCare Pharma Limited Announces End of Phase 2 Meeting with the U.S. Food and Drug Administration Regarding the Clinical Development of Orelabrutinib for the Treatment of Multiple Sclerosis The board of directors of InnoCare Pharma Limited announced that the company have successfully held an End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development of orelabrutinib for the treatment of multiple sclerosis (MS). The FDA and the Company has reached an agreement on the initiation of a phase 3 study of orelabrut in patients with Primary Progressive Multiple Sclerosis (PPMS). This is a significant milestone in ongoing commitment to develop innovative and effective treatments to address unmet medical needs in patients with MS. The U.S. FDA also encouraged to initiate a second phase 3 clinical trial of Orelabrutinib in Progressive Multiple Sclerosis (PMS) in the Secondary Progressive Multiple Sclerosis (SPMS) population. The company fully committed to accelerating the progress of these projects and bringing the much needed therapies to patients. Together, company are one step closer to improving the lives of those living with MS. Announcement • Jul 24
InnoCare Pharma Announces First Subject Dosed in Clinical Trial of TYK2 Inhibitor ICP-332 in the U.S InnoCare Pharma announced that the first subject has been dosed in clinical trial of the Company's novel TYK2 (Tyrosine Kinase 2) inhibitor ICP-332 in the United States. ICP-332 is a potent and selective TYK2 inhibitor. ICP-332 achieved multiple efficacy endpoints in the China Phase II study for the treatment of patients with moderate-to-severe atopic dermatitis (AD), demonstrating an outstanding efficacy and safety profile. ICP-332 showed better efficacy profile across different classes/MoAs of therapies for the treatment of AD patients (not a head-to-head comparison). The detailed data was presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation. Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD anywhere in the world. As a non-receptor tyrosine kinase, TYK2 is a member of the JAK kinase family, which is an important kinase on the JAK-STAT signaling pathway and plays an important role in the pathogenesis of inflammatory diseases. Announcement • Jun 28
InnoCare Pharma Limited to Report First Half, 2024 Results on Aug 21, 2024 InnoCare Pharma Limited announced that they will report first half, 2024 results on Aug 21, 2024 Announcement • Jun 20
InnoCare Pharma Announces the Acceptance of Biologics License Application for Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Adult Patients in China InnoCare Pharma announced that China National Medical Products Administration (NMPA) has accepted and granted priority review to a biologics license application (BLA) for tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide has already been approved for the treatment of eligible DLBCL patients in Hong Kong. Furthermore, under the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide were issued at the Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients. Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditional approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT. DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHLs. Announcement • May 16
InnoCare Pharma Announces the Completion of Patient Enrollment in the Phase II Clinical Trial of ICP-488 for the Treatment of Psoriasis InnoCare Pharma announced the completion of patient enrollment for the phase II clinical trial of ICP-488, a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, for the treatment of psoriasis. This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study aimed at evaluating the efficacy, safety, PK and PD characteristics of ICP-488 in Chinese adult patients with moderate to severe plaque psoriasis. A total of 129 patients were enrolled in this study. Patients were randomly assigned to one of three treatment groups in a 1:1:1 ratio, a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment. ICP-488 is an oral, potent and selective TYK2 allosteric inhibitor. By binding the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases. ICP-488 has demonstrated good efficacy and safety in the phase I study of treating psoriasis patients. Recent data indicates that approximately seven million people in China are currently living with psoriasis, and this number is on the rise. Existing treatment options do not fully address the needs of those affected by this condition, highlighting a significant gap in available therapies. There is a particularly acute demand for new, oral medications. Many patients, especially those with moderate-to-severe psoriasis, continue to be persistently undertreated or remain untreated altogether. Announcement • Mar 13
InnoCare Pharma Limited Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China InnoCare Pharma announced the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination withuton's tyrosine kinase (BTK) inhibitor orelabrutinib as first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China. This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinIB versus immunochemotherapy in treatment-naive patients with CLL/SLL. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. The preliminary result has demonstrated a good efficacy and safety profile. Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications related to lymphoma have been included in the National Reimbursement Drug List (NRDL) in China. In the treatment of relapsed/refractor CLL/SLL patients with orelabrut inib, the overall response rate and complete response rate reached 93.8% and 30% respectively, demonstrating an outstanding efficacy and safety profile. Announcement • Jan 29
InnoCare Pharma Limited Provides Earnings Guidance for the Year Ended 31 December 2023 InnoCare Pharma Limited provided earnings guidance for the year ended 31 December 2023. Based on a preliminary estimate by the finance department, the net loss attributable to owners of the parent company in 2023 is expected to be approximately RMB 656 million, representing a decrease in loss of approximately 26% as compared with the corresponding period of the previous year. The net loss after excluding non-recurring gains or losses attributable to owners of the parent company was approximately RMB 654 million, representing a decrease of approximately 32% as compared with the corresponding period of the previous year. Announcement • Jan 24
InnoCare Announces First Pediatric Patient Dosed in Clinical Trial of pan-TRK Inhibitor Zurletrectinib in China InnoCare Pharma announced that the first pediatric patient has been dosed in clinical trial with its second generation pan-TRK inhibitor zurletrectinib at Sun Yat-sen University Cancer Center. This is the first time that zurletrectinib will be evaluated in a clinical study of pediatric (2 to 12 years old) patients, after demonstrating good safety and efficacy in adult and adolescent patients (12 to 18 years old). Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C. Zurletrectinib could overcome acquired resistance to the first-generation TRK inhibitors. InnoCare has been advancing the registrational trial of zurletrectinib in China and is expecting to submit the new drug application in the second half of 2024. An overall response rate (ORR) of 80-90%, indicating favorable efficacy, was observed in adult patients with various cancers carrying NTRK gene fusion who received dosages of 8 mg or more. Announcement • Jan 16
InnoCare Pharma Announces Clearance of Clinical Trial of BCL2 Inhibitor ICP-248 by U.S. FDA InnoCare Pharma announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Company's B-cell lymphoma-2 (BCL2) inhibitor, ICP-248. This is InnoCare's fifth innovative drug to enter the clinical stage in the U.S. This is a Phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ICP-248 in hematologic malignancy patients. ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. The Phase I dose escalation trial of ICP-248 is ongoing in China, and the preliminary results demonstrated good efficacy and safety profiles. ICP-248 exhibits its anti-tumor effects by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death. Announcement • Dec 11
InnoCare Pharma Announces Latest Data of Oncology Pipelines Presented at the 65th Annual Meeting of ASH InnoCare Pharma announced that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting. The study of orelabrutinib’s regimen in patients with untreated mantle cell lymphoma (MCL) was selected as an oral presentation. A Prospective Multicenter Phase II Study of Orelabrutinib-Lenalidomide-Rituximab (OLR) in Patients with Untreated Mantle Cell Lymphoma (MCL) in China (POLARIS Study): Preliminary Analysis on Efficacy, Safety, Mutation Spectrum and Impact of Mutation Profiling on Treatment Responses: The POLARIS study is a single arm, multicenter, open-label phase II study that uses a combination regimen of orelabrutinib, lenalidomide and rituximab to treat untreated MCL patients, with a maximum duration of 24 cycles. As of July 10, 2023, a total of 28 patients were enrolled. The overall response rate (ORR) was 100%, and the complete response rate (CRR) was 76.2%. The median time to response (TTR) was 3 months, with the estimated 12-month duration of response (DOR) rate and progression-free survival (PFS) rate of 90.9% and 92.3%, respectively. The preliminary findings show that the Orelabrutinib-Lenalidomide-Rituximab exerted synergistic anti-tumor activity, with manageable toxicity in untreated MCL. The first author and corresponding author of the abstract is Professor Huilai Zhang from the Tianjin Medical University Cancer Institute and Hospital. Preliminary Safety, Pharmacological, and Efficacy Data from Patients with Relapsed or Refractory B-cell Malignancies Treated with the ICP-248, a Next Generation BCL2 Inhibitor: This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ICP-248 in patients with relapsed or refractory B-cell malignancies. ICP-248 demonstrated a favorable PK profile, with approximate dose proportionality observed across the ramp-up stage. No dose-limiting toxicities (DLTs) were observed. All the AEs were grade 1 to 2 without dose interruption or modifications. No TLS including laboratory TLS was observed. As of data cutoff date, three patients had been completed tumor assessment. Two patients were assessed as complete response (CR) at the end of cycle 2 with undetectable MRD, and another patient was assessed as stable disease (SD). Preliminary results suggest that ICP-248 is safe and well tolerated in relapsed or refractory B-cell malignancies. Preliminary efficacy data demonstrated good response with deep remission. Further assessment of safety and efficacy with additional dose levels and dosing strategies will be pursued in expanded patient population and in the combination with orelabrutinib. The first author and corresponding author of the abstract is Professor Shuhua Yi from the Chinese Academy of Medical Sciences and Peking Union Medical College. Effectiveness and Safety of Orelabrutinib Combined with Rituximab As First-Line Treatment in Marginal Zone Lymphoma: The retrospective study evaluated the effectiveness and safety of orelabrutinib combined with rituximab as first-line treatment in marginal zone lymphoma (MZL). The primary endpoint was the overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. The ORR was 90%. After a median follow-up of 13.0 months, the median PFS was not reached and a 6-month PFS rate was 100%. Off-target related AEs such as atrial fibrillation, diarrhea, and major hemorrhage were not reported. This retrospective data suggests that orelabrutinib in combination with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile. These results provide a potential first-line treatment strategy in MZL. Further verification in prospective clinical trials of orelabrutinib in first-line MZL is warranted. Announcement • Oct 27
InnoCare Pharma Announces First Patient Dosed in the Phase III Registrational Trial of Orelabrutinib for the Treatment of ITP in China InnoCare Pharma announced that the first patient has been dosed in the Phase III registrational trial of the Company’s BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib for the treatment of primary immune thrombocytopenia (ITP) in China. According to the data presented at the European Hematology Association (EHA) 2023 Hybrid Congress (abstract number: S299), the Phase II study results showed that both 50mg QD and 30mg QD of orelabrutinib were safe in the treatment of patients with ITP, with 40% of patients at the 50mg arm meeting the primary endpoint. Orelabrutinib, a novel BTK inhibitor developed by InnoCare, has high target selectivity and a good safety profile, which makes it suitable for the development of various autoimmune diseases. Currently, there are no BTK inhibitors approved for the treatment of ITP in the world. ITP is an acquired immune mediated disorder characterized by a decrease in peripheral blood platelet counts, resulting in an increased risk of bruising and bleeding. The annual incidence rate of adult ITP is about 2-10 per 100,000 people. Only about 70% of patients respond to first-line treatment. Therefore, it is necessary to explore new therapies. It is expected that orelabrutinib has potential to provide a better treatment option for ITP patients. Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment of r/r MZL in China. In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL). Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of Phase II registrational trial for R/R MCL was completed in the U.S. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024. In addition, the Company has achieved proof of concept (PoC) of orelabrutinib for the treatment of primary immune thrombocytopenia purpura (ITP) and the Phase III registrational trial is ongoing in China. Orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China. Announcement • Oct 12
Innocare Pharma Limited Announces the Appointment of Dandan Dong as Independent Non-Executive Director InnoCare Pharma Limited announced that Dr. Dandan Dong has been appointed as an independent non-executive Director with effect from 11 October, 2023. Dr. Dong is primarily responsible for supervising and providing independent judgement to the Board. Dr. Dong, aged 39, currently serves as the chief business officer of ArriVent Biopharma Inc. Prior to joining ArriVent Biopharma Inc., Dr. Dong worked at Vivo Capital LLC from August 2011 to July 2021, and has held various positions there, including the managing director of Vivo Capital LLC and a managing member of the general partner of Vivo PANDA Fund and Vivo Innovation Fund II, Vivo Capital's early-stage investment vehicles. Since November 2018, Dr. Dong has been serving as a director of VISEN Pharmaceuticals which as of the date of this announcement is in the course of seeking listing of its shares on the Main Board of the Stock Exchange of Hong Kong Limited. Dr. Dong obtained her Bachelor's degree in life science from Sichuan University in July 2006. She completed the Pre-doctoral Fellowship program in infectious disease at New York University in July 2008, and obtained her Ph.D. degree in molecular microbiology from Fudan University in July 2011. Dr. Dong has entered into a service contract with the Company for a term of three years from 11 October, 2023, subject to retirement by rotation and re-election at the annual general meeting in accordance with the articles of association of the Company. In line with the remuneration policy and the recommendation of the remuneration committee of the Company (the "Remuneration Committee"), Dr. Dong will receive a monthly director's service fee of RMB 30,000 upon the effective date of her appointment. Under the terms of the service contract, she is entitled to bonus of such amount as the Board may determine in light of the Company's business performance and the Director's individual performance after confirmation by the Remuneration Committee. Announcement • Sep 22
InnoCare Pharma Limited (SEHK:9969) commences an Equity Buyback Plan for 149,967,323 shares, representing 8.5% of its issued share capital, under the authorization approved on June 2, 2023. InnoCare Pharma Limited (SEHK:9969) commences share repurchases on September 20, 2023, under the program mandated by the shareholders in the Annual General Meeting held on June 2, 2023. As per the mandate, the company is authorized to repurchase up to 149,967,323 shares, representing 8.5% of its issued share capital. The repurchases will lead to an enhancement of the net asset value per share and/or earnings per share for the company. The repurchases will be made out of the funds legally available for such purpose in accordance with its memorandum of association and Bye-laws and the applicable laws and regulations of Cayman Islands. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is varied or revoked in a General Meeting. As of June 2, 2023, the company had 1,764,321,452 shares in issue including 1,499,673,235 Hong Kong Shares and 264,648,217 RMB Shares.
On September 8, 2023, the company announced a share repurchase program. Under the program, the company will repurchase HKD 200 million worth of shares. The share will be repurchased from company's own financial resources. The repurchased shares will be cancelled. Announcement • Sep 14
InnoCare Pharma Announces Approval of Clinical Trial of SHP2 Inhibitor ICP-189 in Combination with EGFR Inhibitor Furmonertinib InnoCare Pharma announced the approval of the Investigational New Drug (IND) to conduct the clinical trial of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor, in China. In mid-July, InnoCare and ArriVent announced the clinical development collaboration to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR or HER2 mutations, including exon 20 insertion mutations and other uncommon EGFR mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCL C with EGFR exon 19 insertion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Shanghai Allist Pharmaceuticals Co. Ltd, who discovered furmonertinib. ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. In the dose escalation study, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK and safety profile has been demonstrated. Preliminary efficacy was observed in ICP-189 monotherapy. One patient with cervical cancer in the 20 mg dose cohort achieved confirmed partial response. Announcement • Sep 13
InnoCare Announces Study Result of Orelabrutinib in Patients with r/r MZL Published by American Journal of Hematology American Journal of Hematology recently published the study result of BTK (Bruton Tyrosine Kinase) inhibitor orelabrutinib in patients with relapsed or refractory (r/r) Marginal Zone Lymphoma (MZL), which investigated the efficacy and safety of orelabrutinib in r/r MZL. The journal concluded that orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in patients with relapsed or refractory MZL. The majority of the enrolled patients had late-stage disease. After a median follow-up duration of 24.3 months, the overall response rate (ORR) assessed by an Independent Review Committee (IRC) ORR was 58.9%. Tumor reduction was observed in 92.2% of patients. The IRC-assessed median duration of response (DOR) was 34.3 months and median progression-free survival (PFS) was not reached. The 12-month PFS rate and overall survival (OS) rate was 82.8% and 91.0% respectively. Due to the high target selectivity and fewer off-target effects, orelabrutinib demonstrated a good safety profile in the treatment of patients with r/r MZL. In China, orelabrutinib was the first and only approved BTK inhibitor for the treatment of r/r MZL. Orelabrutinib has been also approved in China for the treatment of r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL). Marginal zone lymphoma (MZL) is a type of non-Hodgkin lymphoma (NHL) of indolent nature originating from B cells in the marginal zones of the spleen, lymphatic tissue, and lymph nodes. MZL accounts for 7%-8% of NHL cases and is the second most prevalent lymphoma among elderly adults. The annual incidence of MZL has increased globally. The journal concluded that orelabrutinib produced a robust response and was well tolerated in r/r MZL patients. High response rates were consistent among patients with different MZL subtypes and those with negative disease prognostic factors at baseline. The results of this study support the use of orelabrutinib as an effective and tolerable oral treatment option for r/r MZL patients. The American Journal of Hematology is an academic journal focusing on hematology, which was founded in 1976 and published monthly by WILEY publisher. The journal has been included in SCIE and SCI databases, with an impact factor of 13.268 in 2022. Announcement • Jul 15
Innocare Pharma Limited Announces Board Changes The board of directors of InnoCare Pharma Limited hereby announced that Dr. Zemin Jason Zhang has tendered his resignation as an independent non-executive Director, a member of the Audit Committee, a member of the Compensation Committee and a member of the Nomination Committee of the Company with effect from 14 July 2023 as he needed more time for his dedication in academic research as a tenured professor at the School of Life Sciences of Peking University. The Board also announces that subsequent to, and concurrent with the resignation of Dr. Zhang as a member of each of the Compensation Committee, the Nomination Committee and the Audit Committee: Dr. Kaixian Chen, an independent non-executive Director, has been appointed as a member of the Compensation Committee; Ms. Lan Hu, an independent non-executive Director, has been appointed as a member of the Nomination Committee; and Mr. Ronggang Xie, a non-executive Director, has been appointed as a member of the Audit Committee. Announcement • Jun 28
InnoCare Pharma Limited to Report First Half, 2023 Results on Aug 30, 2023 InnoCare Pharma Limited announced that they will report first half, 2023 results on Aug 30, 2023 Announcement • Jan 30
InnoCare Pharma Limited Provides Earnings Guidance for the Year Ended 31 December 2022 InnoCare Pharma Limited provided earnings guidance for the year ended 31 December 2022. The net profit attributable to owners of the parent company in 2022 is expected to be RMB 910 million, representing an increase in loss of approximately 1,309.8% as compared with that of the corresponding period of the previous year. The net profit after excluding non-recurring gains or losses attributable to owners of the parent company in 2022 is expected to be RMB 950 million, representing an increase in loss of approximately 1,670.4% as compared with that of the corresponding period of the previous year. Announcement • Jan 28
InnoCare Pharma Limited Announces the Latest Clinical Result of FGFR Inhibitor Gunagratinib (ICP-192) for the Treatment of Cholangiocarcinoma Was Presented At 2023 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium InnoCare Pharma Limited announced that the latest clinical result of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma was presented at 2023 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium. As of September 5, 2022, 18 cholangiocarcinoma patients were treated orally with gunagratinib 20 mg QD. The median age of the patients was 52 with 44.4% male. Among 17 patients who have completed at least one tumor assessment, the overall response rate (ORR) was 52.9%, the disease control rate (DCR) was 94.1% and median progression free survival (mPFS) was 6.93 months (not reached at cutoff). Gunagratinib showed a well-tolerated safety profile. Announcement • Dec 28
InnoCare Pharma Limited Announces Approval of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Hong Kong InnoCare Pharma Limited announced the approval of tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) by the Department of Health, the Hong Kong Special Administrative Region, China. Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient. Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation. Announcement • Dec 21
InnoCare Announces Approval to Conduct a Phase II Clinical Trial of Orelabrutinib in Combination with Tafasitamab + Lenalidomide in China InnoCare Pharma announced that the Company has received approval from the Center for Drug Evaluation (CDE) to conduct a single-arm, open-label, multi-cohort phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with tafasitamab + lenalidomide for the treatment of patients with relapsed or refractory Non-Hodgkin's lymphoma (NHL). Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filled in July at the Ruijin Hainan Hospital for an eligible DLBCL patient. Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT). Orelabrutinib received conditional approval from the NMPA in two indications: the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and the treatment of patients with relapsed or refractory mantle cell lymphoma. Orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore. NHL is one of the most common cancers in China, including DLBCL, follicular lymphoma, etc. Data shows that there were 92,834 new cases of NHL with 54,351 deaths in 2020 in China. Announcement • Nov 22
InnoCare Pharma Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Mantle Cell Lymphoma in Singapore InnoCare Pharma announced that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL). On December 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with R/R chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with R/R MCL. At the end of 2021, orelabrutinib was included into National Reimbursement Drug List (NRDL) in China. In June 2021, orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of R/R MCL by U.S. Food and Drug Administration (FDA). Mantle cell lymphoma (MCL) is a unique subtype of B-cell non-Hodgkin's lymphoma (NHL), which is invasive and incurable, with increasing incidence rate year by year. MCL is usually in the late stage when diagnosed, facing the challenges of limited treatment and poor prognosis. Announcement • Nov 02
InnoCare Pharma Limited to Report Nine Months, 2022 Results on Nov 11, 2022 InnoCare Pharma Limited announced that they will report nine months, 2022 results on Nov 11, 2022 Announcement • Oct 31
InnoCare Announces First Adolescent Patient Dosed in Clinical Trial of pan-TRK Inhibitor ICP-723 in China InnoCare Pharma announced that the first adolescent patient has been dosed in clinical trial with its second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients. ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors. Among the adult patients with NTRK fusion treated at the recommended Phase II dose (RP2D), ICP-723 showed good efficacy and safety. After the clinical study performed in adolescent patients for the first time, InnoCare will also expand ICP-723 to treat pediatric patients (2 to 12 years old). Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States. Currently there was no dose-limiting toxicities (DLTs) observed at the first dose group. 
