Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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 Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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 Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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 
