Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxanovir granules (Xianlinda®), by the National Medical Products Administration (NMPA) in China, marking it as the first innovative antiviral drug targeting influenza in children aged 2 to 11 years to complete Phase III clinical trials and apply for market approval [1] Company Summary - The collaboration between the company and Jiaxing Antikang Biotechnology Co., Ltd. focuses on the development of Madaxanovir, an innovative antiviral drug for treating uncomplicated influenza in children [1] - Madaxanovir is a cap-dependent endonuclease inhibitor, which works by inhibiting the replication of the influenza virus through blocking the transcription of the virus's own mRNA [1] Clinical Research Summary - Clinical studies indicate that Madaxanovir granules demonstrate good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, and oral efficacy that is unaffected by food, making it more suitable for pediatric patients [1]

Core Viewpoint - The announcement highlights the acceptance of the new drug application for the influenza treatment drug, Madaxanovir granules, by the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company and the pediatric antiviral market in China [1] Group 1: Drug Development and Approval - The new drug application (NDA) for Madaxanovir granules, developed in collaboration with Jiaxing Andikang Biotechnology Co., has been accepted by NMPA on September 3, 2025 [1] - Madaxanovir is the first innovative antiviral drug targeting influenza in children aged 2 to 11 years in China to complete Phase III clinical trials and submit for market approval [1] Group 2: Mechanism of Action - Madaxanovir is a cap-dependent endonuclease inhibitor, which works by inhibiting the replication of the influenza virus through blocking the transcription of the virus's own mRNA [1] Group 3: Clinical Advantages - Clinical studies indicate that Madaxanovir granules demonstrate good safety in pediatric patients, faster symptom relief, quicker viral clearance, lower risk of resistance, and oral efficacy that is unaffected by food [1] - The formulation is particularly suitable for pediatric patients, enhancing its potential market appeal [1]

Simcere Pharmaceutical Group Limited 先聲藥業集團有限公司 （於香港註冊成立的有限公司） （股份代號：2096） 自願公告 瑪氘諾沙韋顆粒新藥上市申請(NDA)獲國家藥品監督管理局受理 本公告由先聲藥業集團有限公司（「本公司」），連同其附屬公司統稱（「本集團」） 自願作出，以告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年9月3日，本集團與嘉興 安帝康生物科技有限公司（「安帝康」）合作的抗流感藥物瑪氘諾沙韋顆粒（先林達®） 新藥上市申請（「NDA」）獲國家藥品監督管理局（NMPA）受理，用於治療 2至11歲兒童無併發症的甲型流感和乙型流感，為中國首個成功完成III期臨床並申 報上市的針對兒童患者的抗流感病毒創新藥。 關於瑪氘諾沙韋 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，概不對因本公告全部 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。 瑪氘諾沙韋是一款cap依賴型核酸內切酶抑制劑。瑪氘諾沙韋的作用機制是通過抑 制 ...