InnoCare Pharma(INCP.F)株式概要InnoCare Pharma Limitedはバイオ医薬品会社で、中国におけるがんおよび自己免疫疾患の治療薬の発見、開発、商業化に従事している。 詳細INCP.F ファンダメンタル分析スノーフレーク・スコア評価3/6将来の成長1/6過去の実績2/6財務の健全性4/6配当金0/6報酬当社が推定した公正価値より70.2%で取引されている 収益は年間14.24%増加すると予測されています 今年は黒字化を達成 リスク分析今後3年間の収益は年平均25.1%減少すると予測されている。 高いレベルの非現金収入 株式の流動性は非常に低い すべてのリスクチェックを見るINCP.F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$1.556.2% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-2b5b2016201920222025202620282031Revenue CN¥4.9bEarnings CN¥1.4bAdvancedSet Fair ValueView all narrativesInnoCare Pharma Limited 競合他社Kiniksa Pharmaceuticals InternationalSymbol: NasdaqGS:KNSAMarket cap: US$4.1bACADIA PharmaceuticalsSymbol: NasdaqGS:ACADMarket cap: US$3.6bCatalyst PharmaceuticalsSymbol: NasdaqCM:CPRXMarket cap: US$3.8bVeracyteSymbol: NasdaqGM:VCYTMarket cap: US$3.6b価格と性能株価の高値、安値、推移の概要InnoCare Pharma過去の株価現在の株価HK$1.5552週高値HK$2.3152週安値HK$1.55ベータ0.351ヶ月の変化0%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化-58.11%最新ニュースお知らせ • May 14InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054InnoCare 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.お知らせ • May 10InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In ChinaInnoCare 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.お知らせ • Apr 29InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLEInnoCare 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.お知らせ • Apr 21InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794InnoCare 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.お知らせ • Mar 30InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026お知らせ • Mar 25+ 1 more updateInnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026InnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026.最新情報をもっと見るRecent updatesお知らせ • May 14InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054InnoCare 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.お知らせ • May 10InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In ChinaInnoCare 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.お知らせ • Apr 29InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLEInnoCare 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.お知らせ • Apr 21InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794InnoCare 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.お知らせ • Mar 30InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026お知らせ • Mar 25+ 1 more updateInnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026InnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026.お知らせ • Mar 16InnoCare Pharma Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in ChinaInnoCare 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.お知らせ • Mar 02InnoCare Pharma's Next-Generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in ChinaInnoCare 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.お知らせ • Feb 26InnoCare Pharma Announces Key Developments of Critical Clinical StudiesInnoCare 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.お知らせ • Feb 13InnoCare Pharma Announces First Patient Dosed in the Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in ChinaInnoCare 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.お知らせ • Feb 10Innocare Pharma Announces IND Approval to Initiate Clinical Trial of Vav1 Degrader Icp-538 in ChinaInnoCare 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.お知らせ • Dec 26InnoCare Pharma Limited to Report Fiscal Year 2025 Results on Mar 26, 2026InnoCare Pharma Limited announced that they will report fiscal year 2025 results on Mar 26, 2026お知らせ • Dec 18InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in ChinaInnoCare 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.お知らせ • Dec 17InnoCare Pharma Announces Achievement of Primary Endpoint in Phase 2b Study of OrelabrutinibZenas 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.お知らせ • Dec 15InnoCare Pharma Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical TrialInnoCare 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.お知らせ • Dec 11InnoCare Pharma Announces Approval of the Next-Generation TRK Inhibitor zurletrectinib in ChinaInnoCare 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.お知らせ • Dec 10InnoCare Pharma Announces over 20 Studies of its Novel BTK Inhibitor Orelabrutinib Presented at the 67th Annual Meeting of the American Society of HematologyInnoCare 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).お知らせ • Dec 09InnoCare 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.お知らせ • Nov 28InnoCare Pharma Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo NodularisInnoCare 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.株主還元INCP.FUS BiotechsUS 市場7D0%3.1%1.2%1Yn/a34.6%28.7%株主還元を見る業界別リターン: INCP.FがUS Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: INCP.F US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is INCP.F's price volatile compared to industry and market?INCP.F volatilityINCP.F Average Weekly Movementn/aBiotechs Industry Average Movement10.8%Market Average Movement7.2%10% most volatile stocks in US Market16.4%10% least volatile stocks in US Market3.1%安定した株価: INCP.Fの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のINCP.Fのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO(最高経営責任者ウェブサイト20151,176Jasmine Cuiwww.innocarepharma.comInnoCare Pharma Limitedはバイオ医薬品企業で、中国においてがんおよび自己免疫疾患の治療薬の発見、開発、商業化に従事している。同社は、再発・難治性(r/r)の慢性リンパ性白血病、r/rのマントル細胞リンパ腫、r/rのワルデンシュトレーム・マクログロブリン血症、r/rの辺縁帯リンパ腫、r/rのびまん性大細胞型B細胞リンパ腫の患者を治療するBTK阻害剤オレラブルチニブを開発している、びまん性大細胞型B細胞リンパ腫(DLBCL)-MCD、中枢神経系リンパ腫、MIL-62との併用、全身性エリテマトーデス、免疫性血小板減少性紫斑病、多発性硬化症、視神経脊髄炎スペクトラム障害。また、汎FGFR阻害剤ICP-192を開発中で、胆管癌や頭頸部癌を含む固形癌患者の治療薬として第I/II相臨床試験中である。汎TRK阻害剤ICP-723は、神経栄養性チロシン受容体キナーゼ融合陽性癌の治療薬として第I相臨床試験中である;自己免疫疾患治療薬として第I相臨床試験中の新規チロシンキナーゼ2阻害薬ICP-332、リンパ腫治療薬として二重特異性抗体ICP-B02。また、固形がん治療薬としてICP-189とICP-B03、肝がん、腎細胞がん、大腸がん、その他の固形がん治療薬としてICP-033、自己免疫疾患治療薬としてICP-488、各種がん治療薬として抗CCケモカイン受容体8モノクローナル抗体ICP-B05、血液疾患治療薬としてICP-248、血液疾患と自己免疫疾患治療薬としてICP-490を開発している。さらに、DLBCL/血液内科の治療薬としてICP-B04(Tafasitamab)を提供している。同社はArriVent Biopharma, Inc.と、進行非小細胞肺がん患者を対象にフルモナルチニブと併用したICP-189の抗腫瘍活性と安全性を評価する臨床共同研究を行っている。InnoCare Pharma Limitedは2015年に法人化され、中国の北京に本社を置いている。もっと見るInnoCare Pharma Limited 基礎のまとめInnoCare Pharma の収益と売上を時価総額と比較するとどうか。INCP.F 基礎統計学時価総額US$3.18b収益(TTM)US$107.49m売上高(TTM)US$371.22m24.2xPER(株価収益率7.0xP/SレシオINCP.F は割高か?公正価値と評価分析を参照収益と収入最新の決算報告書(TTM)に基づく主な収益性統計INCP.F 損益計算書(TTM)収益CN¥2.52b売上原価CN¥217.94m売上総利益CN¥2.30bその他の費用CN¥1.57b収益CN¥730.32m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益(EPS)0.43グロス・マージン91.36%純利益率28.95%有利子負債/自己資本比率24.3%INCP.F の長期的なパフォーマンスは?過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日(UTC時間)企業分析2026/05/23 09:27終値2026/02/23 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM(Trailing Twelve Month)またはLTM(Last Twelve Month)データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋InnoCare Pharma Limited 10 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。22 アナリスト機関Pei ChengChina Galaxy Securities Co., Ltd.Peng ZouChina International Capital Corporation LimitedJin ZhangChina International Capital Corporation Limited19 その他のアナリストを表示
お知らせ • May 14InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054InnoCare 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.
お知らせ • May 10InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In ChinaInnoCare 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.
お知らせ • Apr 29InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLEInnoCare 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.
お知らせ • Apr 21InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794InnoCare 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.
お知らせ • Mar 30InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026
お知らせ • Mar 25+ 1 more updateInnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026InnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026.
お知らせ • May 14InnoCare Pharma Announces First Subject Dosed In Phase 1 Clinical Trial of ICP-054InnoCare 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.
お知らせ • May 10InnoCare Pharma Announces Approval Of Phase II Clinical Trial Of TYK2 Inhibitor ICP-488 For Sjögren's Syndrome In ChinaInnoCare 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.
お知らせ • Apr 29InnoCare Pharma Announces First Patient Dosed In Phase III Trial Of Orelabrutinib For SLEInnoCare 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.
お知らせ • Apr 21InnoCare Pharma Unveils Preclinical Data Of Novel B7-H3 Targeted ADC ICP-B794InnoCare 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.
お知らせ • Mar 30InnoCare Pharma Limited to Report Q1, 2026 Results on Apr 24, 2026InnoCare Pharma Limited announced that they will report Q1, 2026 results on Apr 24, 2026
お知らせ • Mar 25+ 1 more updateInnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026InnoCare Pharma Limited, Annual General Meeting, Jun 16, 2026.
お知らせ • Mar 16InnoCare Pharma Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in ChinaInnoCare 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.
お知らせ • Mar 02InnoCare Pharma's Next-Generation TRKi Zurletrectinib Receives Priority Review for the Treatment of Pediatric Patients with Solid Tumors in ChinaInnoCare 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.
お知らせ • Feb 26InnoCare Pharma Announces Key Developments of Critical Clinical StudiesInnoCare 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.
お知らせ • Feb 13InnoCare Pharma Announces First Patient Dosed in the Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in ChinaInnoCare 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.
お知らせ • Feb 10Innocare Pharma Announces IND Approval to Initiate Clinical Trial of Vav1 Degrader Icp-538 in ChinaInnoCare 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.
お知らせ • Dec 26InnoCare Pharma Limited to Report Fiscal Year 2025 Results on Mar 26, 2026InnoCare Pharma Limited announced that they will report fiscal year 2025 results on Mar 26, 2026
お知らせ • Dec 18InnoCare Announces Approval of Phase II/III Clinical Trial of Novel TYK2 Inhibitor Soficitinib for Chronic Spontaneous Urticaria in ChinaInnoCare 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.
お知らせ • Dec 17InnoCare Pharma Announces Achievement of Primary Endpoint in Phase 2b Study of OrelabrutinibZenas 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.
お知らせ • Dec 15InnoCare Pharma Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical TrialInnoCare 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.
お知らせ • Dec 11InnoCare Pharma Announces Approval of the Next-Generation TRK Inhibitor zurletrectinib in ChinaInnoCare 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.
お知らせ • Dec 10InnoCare Pharma Announces over 20 Studies of its Novel BTK Inhibitor Orelabrutinib Presented at the 67th Annual Meeting of the American Society of HematologyInnoCare 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).
お知らせ • Dec 09InnoCare 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.
お知らせ • Nov 28InnoCare Pharma Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo NodularisInnoCare 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.