智飞生物子公司CA508注射液Ⅲ期临床总结报告落地 2型糖尿病治疗添本土创新选项

Core Viewpoint - Chongqing Zhifei Biological Products Co., Ltd. has achieved a significant breakthrough in the treatment of metabolic diseases with the successful completion of Phase III clinical trials for its CA508 injection, paving the way for future product registration [1][2]. Group 1: Product Development - The CA508 injection is a new generation of dual insulin formulation, combining long-acting insulin (degludec) and rapid-acting insulin (aspart), which allows for precise control of both baseline and postprandial blood sugar levels while significantly reducing the risk of hypoglycemia [2]. - The formulation is designed for ease of use, requiring only 1-2 injections per day without the need for mixing prior to use, thereby improving patient compliance [2]. Group 2: Clinical Trial Details - The Phase III clinical trial was led by Peking University People's Hospital and involved 40 research centers across China, employing a multi-center, randomized, open-label, parallel-controlled design [2]. - The trial focused on type 2 diabetes patients who had poor blood sugar control after previous treatment with basal or premixed insulin, addressing an unmet clinical need [2]. - The clinical trial summary report indicates that CA508 injection's efficacy and safety are comparable to the original drug, providing a solid basis for subsequent registration applications [2]. Group 3: Market Landscape - As of the announcement date, only one other company has a similar product approved in the domestic market, positioning CA508 injection as a promising local innovative treatment option for type 2 diabetes patients [3]. - Zhifei Biological aims to accelerate the transformation of research results into practical applications, guided by public health needs [3].