Core Viewpoint - The company has successfully included its innovative enzyme replacement therapy, CAN 103, in China's first version of the "Commercial Insurance Innovative Drug Directory," effective from January 1, 2026, marking a significant milestone for the group [1] Group 1: Product Development - CAN 103 is the first domestically developed enzyme replacement therapy in China, approved for use in adolescents aged 12 and above and adults with Type I and III Gaucher disease [1] - The drug was approved for market launch on May 13, 2025, and is recognized as the first innovative biological drug in China to pass the segmented production inspection for biological products [1] Group 2: Clinical Application - On July 2, 2025, CAN 103 was prescribed for the first time at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, indicating its official entry into clinical use [1] - The introduction of CAN 103 is expected to significantly enhance the accessibility of medication for domestic patients [1] Group 3: Market Impact - The inclusion of CAN 103 in the insurance directory ensures that Gaucher disease patients will have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [1]

Core Viewpoint - The inclusion of CAN 103 in China's first version of the "Commercial Insurance Innovative Drug Directory" marks a significant milestone for the company, ensuring broader access to effective domestic enzyme replacement therapy for Gaucher disease patients [1][2]. Group 1: Product Development and Approval - CAN 103 is the first domestically developed enzyme replacement therapy for Gaucher disease in China, approved for use in adolescents aged 12 and above and adults with Type I and III Gaucher disease [1]. - The drug was approved for market launch on May 13, 2025, and officially entered clinical application on July 2, 2025, at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine [1]. Group 2: Regulatory and Market Context - The "Commercial Insurance Innovative Drug Directory" is set to be implemented on January 1, 2026, and includes innovative drugs that exceed basic insurance coverage and have significant clinical value [1]. - In the 2025 medical insurance negotiations, 121 drug varieties applied for inclusion in the directory, but only 24 were selected for negotiation [1]. Group 3: Impact on Patients and Healthcare - The inclusion of CAN 103 in the directory will ensure that Gaucher disease patients have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [2].

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依賴該等內 容而引致的任何損失承擔任何責任。 CAN 103於2025年5月13日獲批上市，是中國首個本土自主研發生產適用於12歲及以上青少年和成人 I型和Ⅲ型戈謝病患者的長期酶替代療法，亦為中國首個通過生物製品分段生產檢查的創新生物藥。 於2025年7月2日，CAN 103在上海交通大學醫學院附屬新華醫院開出首方，標誌著該藥物正式進入 臨床應用，未來將大大提升國內患者用藥可及。 CANbridge Pharmaceuticals Inc. 北海康成製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1228） 本公司認為，CAN 103納入該目錄為本集團的里程碑成就，乃由於此舉將確保戈謝病患者用得上、 用得起安全有效的國產酶替代療法，獲得更廣泛更全面的治療保障。 自願公告 北海康成製藥有限公司（「本公司」，連同其附屬公司，統稱「本集團」）董事會欣然宣佈，本集團的國 內首個本土自主研發生產的酶替代療法一類創新藥CAN 103已成功納入中國第 ...