自願公告 JSKN 003於中國再次獲授予突破性治療認定 用於治療HER2陽性晚期結直腸癌患者 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，概不對因本公告全部或任何部份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 在 2025 年 美 國 臨 床 腫 瘤 學 會 (ASCO ) 年 會 上 ， 一 項「 JSKN 003 單 藥 治 療 晚 期 HER2 高 表 達 （ IHC3 + ）胃腸道腫瘤患者的兩項臨床研究匯總分析」被發表。該項匯總分析包括在澳大利亞 進行的I期臨床研究(JSKN 003 -101)和在中國進行的I / II期臨床研究(JSKN 003 -102)。截至2025 年2 月 28 日 ，兩項 研究 共入組 50 例 HER2高 表達 的晚期 胃腸道 腫瘤 患者（ 其 中23 例為結 直腸 癌 ），其中38 %的患者既往接受過≥ 3線抗腫瘤治療。初 ...

Core Viewpoint - The company has received breakthrough therapy designation from the National Medical Products Administration of China for JSKN 003, a targeted HER2 bispecific antibody-drug conjugate, aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in all patient populations [1][4] Industry Summary - Ovarian cancer ranks as the third most common gynecological malignancy among women in China, with the highest mortality rate among female reproductive tract cancers, as approximately 70% of patients are diagnosed at an advanced stage [2] - Current treatment primarily involves tumor reduction surgery combined with postoperative platinum-based chemotherapy, but nearly all patients eventually develop resistance to platinum [2] - For platinum-resistant patients, non-platinum single-agent chemotherapy is the recommended treatment, but it has limited efficacy, with low objective response rates (ORR) and short median progression-free survival (PFS) and overall survival, indicating a significant unmet clinical need [2] Clinical Research Findings - A summary analysis of two clinical studies presented at the 2024 European Society for Medical Oncology (ESMO) annual meeting included 50 platinum-resistant participants treated with JSKN 003, showing an ORR of 56.8% and a disease control rate (DCR) of 95.5% [3] - Among 44 evaluable participants, 39 experienced tumor shrinkage, and the 6-month PFS rate was 44.7%, with HER2 expression levels influencing response rates [3] - The safety profile was favorable, with only 10% of participants experiencing grade 3 or higher treatment-related adverse events (TRAEs), and no treatment-related deaths reported [3] Ongoing Development - The Phase III clinical trial for this indication is currently in the enrollment stage and progressing smoothly [4] - JSKN 003 is also undergoing multiple Phase II and III clinical studies in China for the treatment of breast cancer, gastric cancer, colorectal cancer, and biliary tract cancer [4] - The breakthrough therapy designation is expected to expedite the development and review process, positioning JSKN 003 as a potential first-line anti-HER2 treatment for all platinum-resistant ovarian cancer patients [4]