Jiangsu Hengrui Pharmaceuticals (01276): The application for the drug license for SHR7280 tablets has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that the company recently received a "Notice of Acceptance" issued by the National Medical Products Administration, indicating that the company's application for marketing approval for SHR7280 tablets has been accepted by the National Medical Products Administration. In November 2024, the Phase III clinical trial (SHR7280-302) of SHR7280 tablets reached the pre-specified primary endpoint of the protocol. This study, conducted in infertile female subjects with acetic acid ganirelix injection as the control, is a multicenter, randomized, double-blind, double-simulation, non-inferiority Phase III clinical study. The study was led by Dr. Qiao Jie, a researcher from Beijing University Third Hospital, and a total of 317 infertile female subjects were enrolled in the study. The results of the study show that in controlled ovarian stimulation with assisted reproductive technology, oral SHR7280 tablets have comparable clinical efficacy to subcutaneous injection of acetic acid ganirelix. SHR7280 can effectively prevent early LH surges, avoid premature ovulation, and have an overall good safety profile.