Zhi Tong Cai Jing·2026-02-05 09:46Core Viewpoint - Heng Rui Medicine has received acceptance for the listing application of HR091506 tablets from the National Medical Products Administration, indicating progress in the drug's approval process [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 gout patients with high uric acid levels, involving 442 participants across 73 centers [1] - The HR091506-302 study also assessed the efficacy and safety of HR091506 tablets in gout patients, with 765 participants across 71 centers [1] - Both studies showed that HR091506 tablets significantly outperformed the control group on primary endpoints and demonstrated good long-term safety and tolerability in patients [1] Group 2: Product Development - HR091506 tablets are developed using gastric retention formulation technology, featuring a pulse release characteristic with both immediate and delayed release components [2] - The immediate release part quickly achieves effective blood drug concentration, while the delayed release part maintains the concentration over an extended period [2] - The total R&D investment for HR091506 tablets has reached approximately 127 million yuan (unaudited) [2]