Group 1 - The company Dongyangguang Pharmaceutical has received approval from the National Medical Products Administration of China for its SGLT-2 inhibitor, Ologliptin capsules, which are intended for improving blood glucose control in adults with type 2 diabetes [1] - The approval is based on two Phase III clinical trials that demonstrated statistically significant reductions in HbA1c levels after 24 weeks of treatment, along with improvements in fasting blood glucose and postprandial blood glucose [1] - The product also showed additional metabolic benefits, including weight loss and blood pressure reduction, aligning with the current trend of comprehensive management of diabetes focusing on blood glucose, weight, and blood pressure [1] Group 2 - Diabetes is now the third most serious chronic non-communicable disease globally, with a prevalence rate of 13.79% among adults in China, translating to approximately 148 million patients [2] - The company has a comprehensive product line in diabetes treatment, including five insulin products that have been approved and are consistent in effectiveness, safety, and quality with original formulations [2] - The new product approval will enhance the company's diabetes product portfolio, and the company plans to leverage its established production system and marketing network for rapid commercialization while exploring further clinical applications for diabetes complications [2]
东阳光药:核心产品奥洛格列净胶囊获得国家药品监督管理局批准上市