ALPHAMAB(09966)
Search documents
康宁杰瑞制药-B:JSKN003的研究进展已于2025年ESMO大会壁报展示期间公布
Zhi Tong Cai Jing· 2025-10-20 01:58
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the research progress of JSKN003, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1: Product Development - JSKN003 is a targeted HER2 bispecific ADC that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology [1] - The coupling reaction of the click reaction conjugate shows better serum stability compared to the maleimide-Michael reaction conjugate [1] - Targeting HER2 bispecificity allows JSKN003 to have stronger endocytic activity and bystander killing effect, demonstrating significant anti-tumor activity in HER2-expressing tumors [1] Group 2: Licensing and Clinical Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications [1] - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B:JSKN003再次获得CDE突破性疗法认定
Zhi Tong Cai Jing· 2025-10-20 01:58
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (1093), has received breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1: Product Development and Clinical Trials - JSKN003 has previously received breakthrough therapy designation for treating PROC, regardless of HER2 expression levels [1] - CRC is the second most common malignant tumor in China, with over 500,000 new cases annually and a rising trend [1] - There are currently no approved anti-HER2 targeted therapies for CRC in China, and existing therapies for HER2+ advanced CRC patients have a median progression-free survival (mPFS) of only 2.0-3.7 months and a median overall survival (mOS) of approximately 7-10 months, indicating a significant unmet clinical need [1] Group 2: Clinical Research Findings - A summary analysis presented at the 2025 ASCO annual meeting showed that JSKN003 monotherapy for HER2 high-expressing advanced CRC patients demonstrated significant efficacy and good safety [2] - The analysis included 50 HER2 high-expressing advanced gastrointestinal cancer patients, with 23 being CRC patients; 38% had previously received three or more lines of anti-tumor therapy [2] - Among 21 HER2 high-expressing CRC patients who underwent at least one tumor efficacy assessment, the overall response rate (ORR) was 61.9%, disease control rate (DCR) was 95.2%, mPFS was 13.77 months, and median duration of response (mDoR) was 12.06 months [2] - In a subgroup of 20 BRAF V600E wild-type CRC patients, the ORR reached 65.0% [2] - Safety data indicated that out of 43 patients who received the recommended phase II dose, only 14.0% experienced grade 3 or higher treatment-related adverse events (TRAEs) [2] Group 3: Mechanism and Collaboration - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to a recombinant humanized anti-HER2 bispecific antibody using glycosylation point coupling technology, providing better serum stability [3] - The bispecific targeting of HER2 enhances JSKN003's internalization activity and bystander killing effect, resulting in strong anti-tumor activity in HER2-expressing tumors [3] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotech to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications, with three ongoing phase III clinical trials for HER2+ breast cancer, HER2 low-expressing breast cancer, and PROC [3]
康宁杰瑞制药-B(09966):JSKN003的研究进展已于2025年ESMO大会壁报展示期间公布
智通财经网· 2025-10-20 00:54
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the research progress of JSKN003, a targeted HER2 bispecific ADC, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1 - JSKN003 utilizes glycosylation site-specific conjugation technology to link a topoisomerase I inhibitor to the KN026 antibody, enhancing serum stability compared to traditional conjugation methods [1] - The bispecific targeting of HER2 provides JSKN003 with stronger endocytic activity and bystander killing effects, demonstrating significant antitumor activity in HER2-expressing tumors [1] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. for the development, sale, and commercialization of JSKN003 in mainland China for tumor-related indications [1] Group 2 - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B(09966):JSKN003再次获得CDE突破性疗法认定
智通财经网· 2025-10-20 00:40
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (1093), has received CDE breakthrough therapy designation for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1: Product Development and Clinical Trials - JSKN003 has previously received CDE breakthrough therapy designation for treating PROC, regardless of HER2 expression levels [1] - CRC is the second most common malignant tumor in China, with over 500,000 new cases annually and a rising trend, yet there are no approved anti-HER2 targeted therapies for CRC in the country [1] - Current approved therapies for HER2+ advanced CRC patients have a median progression-free survival (mPFS) of only 2.0-3.7 months and a median overall survival (mOS) of approximately 7-10 months, indicating a significant unmet clinical need [1] Group 2: Clinical Research Findings - A summary analysis of two clinical studies presented at the 2025 ASCO annual meeting showed that JSKN003 monotherapy for HER2 high-expressing advanced CRC patients demonstrated significant efficacy and good safety [2] - The studies included 50 HER2 high-expressing advanced gastrointestinal cancer patients, with 23 being CRC patients; the overall response rate (ORR) was 61.9%, and the disease control rate (DCR) was 95.2% [2] - Among 21 HER2 high-expressing CRC patients who had at least one tumor efficacy assessment, the mPFS was 13.77 months, and the median duration of response (mDoR) was 12.06 months [2] Group 3: Mechanism and Collaboration - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology, providing better serum stability [3] - The bispecific targeting of HER2 enhances JSKN003's internalization activity and bystander killing effect, resulting in strong anti-tumor activity in HER2-expressing tumors [3] - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotech to develop, sell, and commercialize JSKN003 for tumor-related indications in mainland China, with three ongoing Phase III clinical trials for HER2+ breast cancer, HER2 low-expressing breast cancer, and PROC [3]
康宁杰瑞制药-B(09966.HK):JSKN003研究进展已于2025年ESMO大会壁报展示期间公布
Ge Long Hui· 2025-10-20 00:15
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced the research progress of JSKN003, a targeted HER2 bispecific ADC, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1: Product Development - JSKN003 is a targeted HER2 bispecific ADC that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology [1] - The coupling reaction of the click reaction conjugate shows better serum stability compared to the maleimide-Michael reaction conjugate [1] - JSKN003 exhibits stronger endocytosis activity and bystander killing effect due to its dual targeting of HER2, demonstrating significant antitumor activity in HER2-expressing tumors [1] Group 2: Licensing and Clinical Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications [1] - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [1]
康宁杰瑞制药-B(09966.HK):JSKN003再次获得CDE突破性疗法认定
Ge Long Hui· 2025-10-20 00:09
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced that its collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group (01093.HK), has led to the breakthrough therapy designation from CDE for JSKN003, aimed at treating HER2+ advanced colorectal cancer (CRC) patients who have failed prior treatments with oxaliplatin, fluorouracil, and irinotecan [1] Group 1 - JSKN003 has previously received breakthrough therapy designation from CDE in March 2025 for treating PROC, with no restrictions on HER2 expression levels [1]
康宁杰瑞制药(09966) - 自愿公告 - JSKN003於2025年ESMO大会上展示的研究进展
2025-10-20 00:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 自願公告 JSKN003於2025年ESMO大會上展示的研究進展 本公告乃由康寧傑瑞生物製藥(「本公司」,連同其附屬公司統稱「本集團」)自願作 出,以知會本集團股東(「股東」)及潛在投資者有關本集團之最新業務進展。 本公司董事(「董事」)會(「董事會」)欣然宣佈,JSKN003的研究進展已於2025年 10月17日至10月21日舉行的2025年ESMO大會壁報展示期間公佈。此研究進展概 述如下。 JSKN003治療原發性鉑難治OC患者的療效及安全性 JSKN003-102為一項在中國晚期實體瘤患者中開展的I期(劑量遞增及劑量擴展) 及II期(隊列擴展)臨床研究。截至2025年6月13日,共有26名原發性鉑難治OC患 者接受JSKN003治療(6.3mg/kg,Q3W)。患者中位年齡為54歲,其 ...
康宁杰瑞制药(09966) - 自愿公告 - JSKN003再次获得CDE突破性疗法认定
2025-10-20 00:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 自願公告 JSKN003再次獲得CDE突破性療法認定 本公告乃由康寧傑瑞生物製藥(「本公司」,連同其附屬公司統稱「本集團」)自願作 出,以知會本集團股東(「股東」)及潛在投資者有關本集團之最新業務進展。 本公司董事(「董事」)會(「董事會」)欣然宣佈,與石藥集團有限公司(股份代號: 1093)附屬公司上海津曼特生物科技有限公司合作開發的JSKN003獲得CDE突破 性療法認定,用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2+ 晚期CRC患者。此前,JSKN003已於2025年3月獲得CDE突破性療法認定,用於 治療PROC,且不限HER2表達水平。有關詳情請參閱本公司日期為2025年3月18 日的公告。 本公司曾在2025年美國臨床腫瘤學會(ASCO)年會上發表過一項JSKN00 ...
康宁杰瑞制药-B(09966):KN026的III期临床试验的最新研究成果于2025年ESMO大会以LBA口头报告形式呈列
智通财经网· 2025-10-17 14:07
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the interim analysis results of the KN026 combined chemotherapy for HER2+ GC (including GEJ) in a Phase III clinical trial, showing significant clinical benefits compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis demonstrated that KN026 combined chemotherapy achieved clinically meaningful and statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to the placebo group [2]. - The median follow-up time for the Anlotinib group was 9.7 months, while the control group had a median follow-up of 9.8 months [2]. Group 2: Patient Characteristics - The baseline characteristics of patients in both groups were generally balanced, with a median age of approximately 64 years in the Anlotinib group and 61 years in the control group [1]. - Over 80% of patients in both groups had an ECOG PS score of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment [1]. Group 3: Mechanism of Action - KN026 aims to be a next-generation HER2-targeted therapy, capable of dual binding to two clinically validated HER2 epitopes (epitopes II and IV) while retaining the wild-type Fc region [2]. - This mechanism allows KN026 to dual-block HER2-related signaling pathways, enhance binding to HER2 receptors, reduce surface HER2 protein, and improve tumor-killing effects through complete antibody-dependent cellular cytotoxicity [2]. Group 4: Ongoing Clinical Trials - Multiple Phase III clinical trials are currently underway in China, including KN026 combined with docetaxel for first-line treatment of HER2+ breast cancer, and KN026 combined chemotherapy for second-line and above treatment of HER2+ GC/GEJ [3].
康宁杰瑞制药-B:KN026的III期临床试验的最新研究成果于2025年ESMO大会以LBA口头报告形式呈列
Zhi Tong Cai Jing· 2025-10-17 13:47
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced the interim analysis results of the KN026 combined chemotherapy for HER2+GC (including GEJ) in a Phase III clinical trial, indicating significant clinical benefits in progression-free survival (PFS) and overall survival (OS) compared to the control group [1][2]. Group 1: Clinical Trial Results - The interim analysis presented at the 2025 ESMO conference showed that KN026 combined with chemotherapy demonstrated clinically meaningful and statistically significant benefits in PFS and OS compared to the placebo group [2]. - The median follow-up time for the Anlotinib group was 9.7 months, while the control group had a median follow-up of 9.8 months [2]. Group 2: Patient Characteristics - The baseline characteristics of patients in both groups were generally balanced, with a median age of approximately 64 years in the Anlotinib group and 61 years in the control group [1]. - Over 80% of patients in both groups had an ECOG PS score of 1, and nearly all patients were diagnosed with stage IVB disease at enrollment [1]. Group 3: Mechanism of Action - KN026 aims to be a next-generation HER2-targeted therapy, capable of dual binding to two clinically validated HER2 epitopes (epitopes II and IV) while retaining the wild-type Fc region [2]. - This mechanism allows KN026 to dual-block HER2-related signaling pathways, enhance binding to HER2 receptors, reduce surface HER2 protein, and improve tumor-killing effects through complete antibody-dependent cellular cytotoxicity [2]. Group 4: Ongoing Clinical Trials - Multiple Phase III clinical trials are currently underway in China, including KN026 combined with docetaxel for first-line treatment of HER2+BC, KN026 combined chemotherapy for second-line and above treatment of HER2+GC/GEJ, and KN026 combined with docetaxel for neoadjuvant treatment of BC [3].