Core Viewpoint - The announcement highlights the acceptance of the New Drug Application (NDA) for the influenza drug, Madaxanovir Granules (Xianlinda), by the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company and the industry in pediatric antiviral treatments [1] Company Summary - The company has collaborated with Jiaxing Andikang Biotechnology Co., Ltd. for the development of Madaxanovir Granules [1] - This drug is specifically designed for treating uncomplicated Type A and B influenza in children aged 2 to 11 years [1] - Madaxanovir Granules is noted as the first innovative antiviral drug targeting pediatric patients in China to successfully complete Phase III clinical trials and submit for market approval [1] Industry Summary - The acceptance of the NDA represents a breakthrough in the antiviral drug market for children in China, addressing a significant unmet medical need [1] - The development of pediatric-specific antiviral treatments is becoming increasingly important in the healthcare landscape, particularly in response to seasonal influenza outbreaks [1]

Core Viewpoint - The announcement highlights the acceptance of the new drug application (NDA) for the influenza treatment drug, Madaxin (玛氘诺沙韦颗粒), by the National Medical Products Administration (NMPA) in China, marking a significant milestone as it is the first innovative antiviral drug targeting influenza in children to complete Phase III clinical trials and apply for market approval in China [1] Group 1: Drug Details - Madaxin is a cap-dependent endonuclease inhibitor that works by inhibiting the replication of the influenza virus, blocking the transcription of the virus's own mRNA, thereby precisely suppressing viral replication [1] - Clinical studies indicate that Madaxin shows good safety in pediatric patients, faster symptom relief and viral clearance, lower risk of resistance, oral efficacy unaffected by food, and a dosage form more suitable for pediatric patients [1]

格隆汇9月3日丨先声药业(02096.HK)公告，于2025年9月3日，集团与嘉兴安帝康生物科技有限公司("安 帝康")合作的抗流感药物玛氘诺沙韦颗粒(先林达)新药上市申请("NDA")获国家药品监督管理局(NMPA) 受理，用于治疗2至11岁儿童无并发症的甲型流感和乙型流感，为中国首个成功完成III期临床并申报上 市的针对儿童患者的抗流感病毒创新药。 玛氘诺沙韦是一款cap依赖型核酸内切酶抑制剂。玛氘诺沙韦的作用机制是通过抑制流感病毒复制所必 需的cap依赖型核酸内切酶，阻断病毒自身mRNA的转录，从而精准抑制病毒复制。 临床研究显示，玛氘诺沙韦颗粒在儿童患者中安全性良好、症状缓解与病毒清除速度更快、耐药风险更 低、具有口服药效不受食物影响、剂型更适合儿科患者等潜在临床优势。 ...