Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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). Aankondiging • 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. Aankondiging • 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.