Sais Pharmaceuticals: Subsidiary withdraws registration application for Dapagliflozin Tablets

Sai Sheng Pharmaceutical announced that its subsidiary Sai Er Biological has received a "Notice of Termination of Drug Registration Application" from the National Medical Products Administration, agreeing to withdraw its registration application for Dapagliflozin tablets. Dapagliflozin tablets belong to Category 4 chemical drugs, with specifications of 5mg and 10mg. Sai Er Biological submitted a market approval application for this drug in March 2025, but due to changes in policies and regulations requiring further improvements to the application materials, the decision was made to voluntarily withdraw the application after careful consideration. The withdrawal of the application will not have a significant impact on the company's research and development work or business performance. The company will fulfill its disclosure obligations in a timely manner based on the project situation.