Saisen Pharmaceuticals: Subsidiary Withdraws Dapagliflozin Tablets Registration Application

Saisen Pharmaceutical’s announcement: its subsidiary Sair Biological received the National Medical Products Administration’s “Notice of Termination of Drug Registration Application,” agreeing to its withdrawal of the registration application for Dapagliflozin Tablets. Dapagliflozin Tablets fall under Chemical Drug Category 4, with specifications of 5mg and 10mg. In March 2025, Sair Biological submitted a marketing authorization application for this drug. Due to policy and regulatory changes requiring further improvement of the filing materials, after careful consideration, it decided to voluntarily withdraw the application. This withdrawal will not have a significant impact on the company’s R&D work or operating performance. The company will promptly fulfill its information disclosure obligations according to the project’s progress.