亿帆医药股份有限公司关于全资子公司收到药品注册受理通知书的公告

Core Points - Yifan Pharmaceutical's subsidiary Sichuan Defeng Pharmaceutical has received a drug registration acceptance notice from the National Medical Products Administration for the production of Sodium Sapropterin Dihydrochloride Powder [1][2] - The drug is intended for patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive phenylketonuria (PKU) and is applicable for adults and children over one month old [1][2] - The company has invested approximately 4.22 million yuan in the research and development of this project [4] Drug Registration Details - Acceptance Number: CYHS2503557 - Drug Name: Sodium Sapropterin Dihydrochloride Powder - Application Type: Domestic production drug registration license - Specification: 100mg (calculated as C9H15N5O3·2HCl) - Drug Registration Category: Class 3 chemical drug - Applicant: Sichuan Defeng Pharmaceutical [1][2] Market Context - As of the report date, Yifan Pharmaceutical is the only company in China to apply for the registration of Sodium Sapropterin Dihydrochloride Powder, with only one other company, Annora Pharma Private Limited, having submitted a registration for a different category [2] - There are currently no Sodium Sapropterin Dihydrochloride Powder products available on the domestic market [2] - According to IQVIA, the global sales for Sodium Sapropterin Dihydrochloride Powder are projected to be approximately 100 million USD in 2024 [3]