Core Viewpoint - Innovent Biologics has received approval for its drug, Ma Shidu Peptide, for blood sugar control in adults with type 2 diabetes, following its earlier approval for weight management, marking a significant dual indication in metabolic health [1][2]. Group 1: Product Approval and Market Response - Ma Shidu Peptide has been approved for two major indications: weight management and blood sugar control, making it the first dual receptor agonist for weight loss globally [1]. - The drug was launched under the brand name Xin Er Mei in June 2023, and initial market feedback has been positive, although specific sales figures have not been disclosed [1]. - As of September 19, 2023, Ma Shidu Peptide has been distributed across four major channels: hospitals, private clinics, retail, and e-commerce, receiving favorable user feedback [1]. Group 2: Clinical Research and Efficacy - The approval for the blood sugar control indication is based on two Phase III clinical studies conducted in China: DREAMS-1, which validated the drug's efficacy and safety as a monotherapy, and DREAMS-2, which assessed its effectiveness in combination with oral hypoglycemic agents [2]. - The studies included common patient groups: those on monotherapy and those with inadequate control on oral medications, showing that Ma Shidu Peptide outperformed placebo and Dulaglutide 1.5 mg in both blood sugar control and weight management [2]. - The drug also demonstrated improvements in various cardiovascular, liver, and kidney-related metabolic indicators [2]. Group 3: Ongoing Research - In addition to the completed studies, there are currently four ongoing Phase III clinical trials for Ma Shidu Peptide, targeting populations with moderate to severe obesity, metabolic-associated fatty liver disease (MAFLD), and obstructive sleep apnea (OSA) related to obesity [3]. - A head-to-head comparison study with Semaglutide is also being conducted among patients with obesity and type 2 diabetes [3].
信达生物减重药获批2型糖尿病适应证 减重药上市3个月市场反馈如何？公司回应来了