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。 Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 四 環 醫 藥 控 股 集 團 有 限 公 司（「本公司」或「四環醫藥」，連 同 其 附 屬 公 司，統 稱 為 「本集團」）董 事 會（「董事會」）欣 然 宣 佈，本 集 團 旗 下 非 全 資 附 屬 公 司 軒 竹 生 物 科 技 股 份 有 限 公 司（「軒竹生物」）從 臨 床 階 段 腫 瘤 公 司Akamis Bio Ltd.（「Akamis」）授 權引進的產品NG-350A獲 得 美 國 食 品 藥 品 監 督 管 理 局（「FDA」）授 予 快 速 通 道 資 格(Fast Track designation)，用 於 治 療 錯 配 修 復 功 能 完 整(pMMR)的局部晚期直腸癌 (LARC)。軒 竹 生 物 擁 有N ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in the global development of JSKN003 [1] Group 1 - JSKN003 has been granted FTD by the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, indicating its clinical potential [1] - The FDA has also approved a Phase II clinical trial for JSKN003 targeting platinum-resistant recurrent epithelial ovarian cancer with no restrictions on HER2 expression levels [1] - JSKN003 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), and orphan drug designation from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating platinum-resistant recurrent epithelial ovarian cancer is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential and importance of JSKN003 as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) regardless of HER2 expression levels [1] Group 1 - JSKN003 has been approved by the FDA to conduct a Phase II clinical trial for treating PROC with no restrictions on HER2 expression levels [1] - The drug has also received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) [1] - Additionally, JSKN003 has been granted Orphan Drug Designation by the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating PROC is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1]

Core Insights - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Fast Track Designation (FTD) from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in its global development process [1] - JSKN003 has also been approved by the FDA to conduct a Phase II clinical trial for the same indication and has received Breakthrough Therapy Designation from the National Medical Products Administration for both PROC and colorectal cancer, as well as Orphan Drug Designation for gastric/gastroesophageal junction cancer [1] - The FTD designation underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 as a new treatment candidate [1] Clinical Data Summary - The FTD for JSKN003 is based on promising clinical data, with a summary analysis presented at the 2025 American Society of Clinical Oncology Annual Meeting, which included 46 PROC patients [2] - Among these patients, 21 had HER2 IHC 0 (45.7%) and 18 had HER2 IHC 1+, 2+, and 3+ (39.1%), with an overall objective response rate (ORR) of 63.0% and a median progression-free survival (mPFS) of 7.7 months [2] - In patients with HER2 IHC 1+, 2+, and 3+, the ORR was 72.2% and mPFS was 9.4 months, indicating robust PFS benefits across different HER2 expression levels [2] Market Need - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, leading to high recurrence rates and poor prognosis [3] - Treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an ORR of only 10% to 15%, mPFS of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [3] - The FTD is expected to accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [3]