Core Viewpoint - Innovent Biologics announced that its self-developed dual receptor agonist, Ma Shidu Te, has achieved primary and all key secondary endpoints in the Phase III clinical study GLORY-2 for patients with severe obesity (BMI ≥ 30 kg/m²) in China [1] Group 1: Clinical Study Results - The GLORY-2 study included 462 participants, with a baseline average weight of 94.0 kg and average BMI of 34.3 kg/m², and showed significant weight loss with Ma Shidu Te 9 mg compared to placebo [4] - At week 60, the average weight reduction in the Ma Shidu Te 9 mg group was 18.55%, while the placebo group saw only 3.02% [4] - Among participants without type 2 diabetes, the average weight loss in the Ma Shidu Te 9 mg group was 20.08%, compared to 2.81% in the placebo group [4] Group 2: Safety and Tolerability - The safety and tolerability of Ma Shidu Te 9 mg were consistent with the GLORY-1 trial, with no new safety signals identified; gastrointestinal adverse reactions were mostly mild or moderate and transient [5] - The proportion of participants who discontinued treatment due to adverse events was 2.9% in the Ma Shidu Te group and 0% in the placebo group [5] Group 3: Market Implications - Innovent plans to submit a marketing application for Ma Shidu Te 9 mg for adult weight management to the National Medical Products Administration (NMPA) [6] - The development of Ma Shidu Te 9 mg targets the significant obesity burden in China, particularly for patients with a BMI over 32.5 kg/m², who often rely on metabolic surgery for effective weight management [6][7] - The drug aims to provide a new treatment option for the severe obesity population, which has previously had limited non-surgical options [7]
大基数减重三期临床数据喜人，信达拟推大剂量规格玛仕度肽