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]

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]

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]

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]

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 於2025年ASCO年會呈列的JSKN003的最新研究成果 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的最新研究成果已於 2025年5月30日至6月3日舉行的2025年ASCO年會壁報展示期間公佈。此研究進 展概述如下。 有關JSKN003治療多項適應症的有效性及安全性的匯總分析 JSKN003-101為一項於澳大利亞晚期╱轉移性實體瘤患者中開展的首次人體、 開放性標籤和多中心的I期臨床研究，分為劑量遞增階段和劑量擴展階段。 JSKN003-102為一項於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 ...