Hengrui Medicine's fertility drug application accepted for market authorization

Jiangsu Hengrui Medicine Co., Ltd. announced that its drug, SHR7280 tablets, has received acceptance for its marketing authorization application from the National Medical Products Administration. This acceptance pertains to its use in controlling ovarian stimulation in assisted reproductive technology to prevent premature luteinizing hormone (LH) surges.

The acceptance follows positive results from a Phase III clinical trial (SHR7280-302), which met its primary endpoint in November 2024. This multi-center, randomized, double-blind, double-dummy, non-inferiority study compared SHR7280 tablets to ganirelix acetate injection in 317 infertile women. The study concluded that oral SHR7280 demonstrated comparable clinical efficacy to the injectable comparator in preventing premature LH surges and premature ovulation, with a favorable overall safety profile.

SHR7280 is an oral small-molecule GnRH receptor antagonist designed to inhibit the synthesis and release of LH and other gonadotropins. It represents a potential first-in-class oral GnRH antagonist for controlled ovarian hyperstimulation in assisted reproductive technology, with no currently approved oral GnRH antagonists available globally. Total research and development investment for SHR7280 to date stands at approximately CNY 26,351 million.