亿帆医药:盐酸沙丙蝶呤散剂药品注册申请获受理

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has received a production registration application acceptance notice from the National Medical Products Administration for its product, Sodium Sapropterin Dihydrochloride Granules, which is intended to treat high phenylalanine levels in patients with phenylketonuria (PKU) [1] Group 1 - Yifan Pharmaceutical's wholly-owned subsidiary, Sichuan Defeng Pharmaceutical Co., Ltd., has recently received the acceptance notice for the production registration application [1] - The product is designed to lower blood phenylalanine (Phe) levels in patients with tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) [1] - The medication is applicable for adults and children over one month old [1] Group 2 - The company submitted the production registration application to the National Medical Products Administration in September 2025 and received acceptance in the same month [1]