Core Viewpoint - Heng Rui Medicine's product, injection of Rukang Trastuzumab combined with Atezolizumab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) [1] Group 1 - The orphan drug designation is aimed at drugs used for the prevention, treatment, or diagnosis of rare diseases [1] - The company will have opportunities to benefit from U.S. policy support in product development, registration, and commercialization [1]

本次注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症获得孤 儿药资格认定后，能够加快推进临床试验及上市注册的进度。同时，可享受一定的政策支持，包括但不 限于临床试验费用的税收抵免、免除新药申请费、产品获批后将享受7年的市场独占权。 恒瑞医药（600276）(01276)公布，近日，公司产品注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液和 化疗用于胃癌或胃食管结合部腺癌适应症获得美国食品药品监督管理局(以下简称"美国FDA")授予的孤 儿药资格认定。孤儿药又称罕见病药，是指用于预防、治疗、诊断罕见病的药品。本次公司获得美国 FDA孤儿药资格认定，将有机会在产品研发、注册及商业化等方面享受美国的政策支持。 ...

Core Viewpoint - Heng Rui Medicine (600276) has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Qutuzumab combined with Adebeli monoclonal antibody and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization in the U.S. [1] Group 1 - The product received orphan drug designation from the U.S. FDA [1] - The indication is for gastric cancer or gastroesophageal junction adenocarcinoma [1] - The designation allows for potential policy support in research, registration, and commercialization [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase of nearly 6%, with a cumulative rise of over 65% in the month, currently trading at 10.12 HKD with a transaction volume of 51.2966 million HKD [1] Group 1: Company Developments - Corning Jereh Pharmaceutical announced that its drug JSKN003 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and gastroesophageal junction cancer (GC/GEJ) [1] - JSKN003 is developed using Corning Jereh's proprietary glycosylation site-specific conjugation platform and is a HER2 dual-targeted antibody-drug conjugate (ADC) [1] Group 2: Regulatory and Market Implications - The ODD designation encourages the development of innovative drugs for diseases affecting fewer than 200,000 patients in the U.S. and provides various policy supports for research, development, registration, and commercialization [1] - Following the ODD recognition, JSKN003 is expected to benefit from funding for research expenses, tax reductions for clinical research costs, waivers for prescription drug user fees, and expedited review processes for market approval [1] - Upon approval, the drug is anticipated to receive a seven-year exclusivity in the U.S. market [1]

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） JSKN003獲美國FDA授予用於治療GC/GEJ的孤兒藥資格認定 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，JSKN003已獲美國食品藥品監督 管理局（「FDA」）授予孤兒藥資格認定（「ODD」），用於治療胃癌及胃食管結合部 癌（「GC/GEJ」）。 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。 自願公告 JSKN003是一種靶向人表皮生長因子受體2（「HER2」）雙表位抗體偶聯藥物 （「ADC」），其通過糖基定點偶聯技術將拓撲異構酶I抑制劑連接至抗體KN026 （重組人源化抗HER2雙特異性抗體）的N糖基化位點處。點擊反應偶聯物較馬來 醯亞胺－邁克爾反應的偶聯物具有更好的血清穩定性 ...

Core Viewpoint - Fosun Pharma's subsidiary Henlius Europe GmbH has received orphan drug designation from the European Commission for HLX22, a humanized anti-HER2 monoclonal antibody injection for gastric cancer treatment [1] Group 1: Product Development - HLX22 is developed by the company under a license from AbClon, Inc. and is intended for the treatment of solid tumors such as gastric and breast cancer [1] - As of April 2025, the company has invested approximately 310 million yuan in the research and development of HLX22 [1] Group 2: Market Potential - According to IQVIA MIDAS data, the global sales of targeted HER2 monoclonal antibody products are projected to be approximately 9.029 billion USD in 2024 [1] - The orphan drug designation will facilitate HLX22's subsequent research, registration, and commercialization in the European Union by providing policy support [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的內容概不負責，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。 本公司董事會（「董事會」）欣然宣佈，近日，本公司全資子公司Henlius USA Inc.收到美國食品藥品管理局（「美國FDA」）的函，HLX22（重組人源化抗 HER2單克隆抗體注射液）（「HLX22」）用於胃癌(GC)治療獲美國FDA孤兒藥 資格認定(Orphan-drug Designation)。 B. 關於HLX22 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 HLX22（重組人源化抗HER2單克隆抗體注射液）用於胃癌(GC)治療 獲美國食品藥品管理局(FDA)孤兒藥資格認定 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 HLX22為本公司自AbClon, Inc.許可引進，並後續自主研 ...