恒瑞医药(01276.HK):HR091506片上市许可申请获国家药监局受理
Ge Long Hui·2026-02-05 09:47

Core Viewpoint - Heng Rui Medicine (01276.HK) has received the acceptance notice from the National Medical Products Administration for the listing application of HR091506 tablets, indicating progress in its drug development pipeline [1] Group 1: Clinical Research - The listing application is based on two key Phase III clinical studies (HR091506-301 and HR091506-302) that are randomized, double-blind, and have a positive control with febuxostat [1] - The HR091506-301 study evaluated the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia requiring deep uric acid control, involving 442 subjects across 73 centers, led by Professors Zou Hejian and Xue Yu from Huashan Hospital, Fudan University [1] - The HR091506-302 study assessed the efficacy and safety of HR091506 tablets in patients with gout and hyperuricemia, enrolling 765 subjects across 71 centers, with Professor Zhang Zhuoli from Peking University First Hospital as the principal investigator [1] Group 2: Study Results - Results from both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints [1] - The long-term safety and tolerability of HR091506 tablets in patients with gout and hyperuricemia were found to be good [1]

Hengrui Pharma-恒瑞医药(01276.HK):HR091506片上市许可申请获国家药监局受理 - Reportify