Yifan Pharmaceutical: The drug registration application for Sodium Salbutamol Powder has been accepted
Yifan Pharmaceutical announced that the drug registration application for its wholly-owned subsidiary Sichuan Defeng Pharmaceutical Co., Ltd.'s sodium sapropterin dihydrochloride granules has been accepted by the National Medical Products Administration. This drug is suitable for reducing blood phenylalanine levels in patients with tetrahydrobiopterin-responsive phenylketonuria, applicable to adults and children over 1 month old. The application was submitted in September 2025 and has been accepted
According to the Zhitong Finance APP, Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary Sichuan Defeng Pharmaceutical Co., Ltd. recently received the "Acceptance Notice" for the domestic production drug registration application issued by the National Medical Products Administration (referred to as "NMPA") for the hydrochloride of sapropterin dihydrochloride granules.
The hydrochloride of sapropterin dihydrochloride granules is suitable for reducing the phenylalanine (Phe) levels in the blood of patients with hyperphenylalaninemia (HPA) caused by tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU), and can be used for adults and children over 1 month of age. The company submitted the domestic production drug registration application to the NMPA in September 2025 and received acceptance in September 2025
