Group 1 - The core point of the article is that Heng Rui Medicine has received acceptance for its HR091506 tablet's market approval application from the National Medical Products Administration of China [1] - The application is based on two key Phase III clinical studies, HR091506-301 and HR091506-302, which evaluated the efficacy and safety of HR091506 in patients with gout and hyperuricemia [1] - The HR091506-301 study involved 442 participants across 73 centers, while the HR091506-302 study included 765 participants across 71 centers, both showing significant efficacy over the control group [1] Group 2 - HR091506 is a self-developed oral sustained-release tablet utilizing gastric retention technology, featuring both rapid and delayed release components [2] - The rapid-release part quickly achieves effective blood drug concentration, while the delayed-release part maintains the concentration over a longer period [2] - The total R&D investment for the HR091506 project has reached approximately 127 million yuan (unaudited) [2]
恒瑞医药(01276):HR091506片的上市许可申请获国家药监局受理