Core Viewpoint - The announcement highlights that the core product, Isuparaglutide α, has been successfully included in the latest version of China's National Medical Insurance Drug List (2025 edition), effective from January 1, 2026, for the treatment of Type 2 Diabetes (T2D) [1][2]. Group 1: Product Details - Isuparaglutide α is the first domestically developed long-acting GLP-1 receptor agonist in China, approved for monotherapy and in combination with metformin for T2D treatment [1]. - Clinical studies have demonstrated that Isuparaglutide α has a rapid onset, strong and lasting efficacy, a long half-life, and good safety profile [1]. Group 2: Clinical Trial Results - In a Phase III clinical trial, T2D patients receiving Isuparaglutide α monotherapy (3.0 mg) showed a reduction in HbA1c levels by 1.1% after 4 weeks of treatment [1]. - In another randomized, double-blind, placebo-controlled Phase III trial, Isuparaglutide α at doses of 1.0 mg and 3.0 mg resulted in significant reductions in HbA1c levels of 1.7% and 2.2% respectively at week 24, demonstrating both statistical and clinical significance [1]. Group 3: Pharmacokinetics and Safety - Isuparaglutide α has an average half-life of 204 hours, allowing for low dosing frequency in long-term disease management [2]. - The safety profile of Isuparaglutide α is favorable, with no observed cases of drug-related grade 2 or higher hypoglycemia in clinical trials [2].
银诺医药-B(02591.HK):核心产品(即依苏帕格鲁肽α)成功纳入中国最新版《国家医保药品目录》