Yifan Pharmaceutical subsidiary's drug registration application accepted

Yifan Pharmaceutical announced that its subsidiary, Sichuan Defeng Pharmaceutical, received an acceptance notice from the National Medical Products Administration for its application to register Salbutamol Propionate Powder for injection. The application was filed in September 2025 and accepted under reference number CYHS2503557. This drug, a chemical product of category 3, is intended to lower phenylalanine levels in patients with high phenylalanine due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU) in adults and children aged 1 month and above.

Sichuan Defeng Pharmaceutical is positioned to be the first domestic company to apply for marketing authorization for this generic drug in China. Currently, Annora Pharma Private Limited has a marketing application for Salbutamol Propionate Powder in China, classified under chemical drug category 5.2. According to IQVIA data, global sales of Salbutamol Propionate Powder were approximately $100m in 2024.

Yifan Pharmaceutical has invested approximately 4.2204m yuan in the research and development of the Salbutamol Propionate Powder project. The company cautions investors that the approval timeline, results, and sales performance post-approval remain uncertain as the application proceeds through the NMPA’s review process.