亿帆医药：全资子公司收到盐酸沙丙蝶呤散剂境内生产药品注册受理通知书

Core Viewpoint - Yifan Pharmaceutical (002019) has received a production registration acceptance notice from the National Medical Products Administration for its hydrochloride sapropterin dispersible tablets, marking a significant step in the development of a treatment for phenylketonuria (PKU) [1] Company Summary - Yifan Pharmaceutical's wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has been granted the acceptance notice for the registration of hydrochloride sapropterin dispersible tablets [1] - The product is intended to lower blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) caused by tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) and is suitable for adults and children over one month old [1] - As of the report date, Yifan Pharmaceutical is the only company in China to apply for the market registration of hydrochloride sapropterin dispersible tablets, with only one other company, Annora Pharma Private Limited, having submitted a similar application [1] Industry Summary - There are currently no hydrochloride sapropterin dispersible tablets available on the market in China, indicating a potential market opportunity for Yifan Pharmaceutical as the first applicant for this generic drug [1] - The registration application is classified under chemical drug registration category 3, positioning the company as a pioneer in this segment within the domestic market [1]