On 29 December 2021, Shanghai Innogen Pharmaceutical Technology Co., Ltd. held a national investigator meeting at the Shanghai Greenland Marriott Hotel for ‘A multicenter, randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of Efsubaglutide Alfa Injection in patients with type 2 diabetes inadequately controlled on metformin’ (protocol YN011-302).
YN011-302 plans to enroll more than 600 patients with type 2 diabetes to evaluate efsubaglutide alfa's efficacy and safety and generate pivotal clinical data for its marketing application. Dozens of major research centers nationwide were invited to participate. Shanghai Sixth People's Hospital is the lead institution, and Professor Weiping Jia, an academician of the Chinese Academy of Engineering, serves as chief clinical scientist for the efsubaglutide alfa program.
Held both in person and online, the meeting brought together more than 300 investigators, IDMC members, clinical experts and sponsor project-team colleagues from participating centers nationwide. Efsubaglutide alfa inventor and Innogen chairman and CEO Professor Qinghua Wang delivered the welcome address, followed by opening remarks from Academician Weiping Jia.
Professor Wang described the research background, development history and outlook for GLP-1 treatment. Innogen's medical team explained the Phase III protocol in detail, while the team from clinical-operations partner R&G PharmaStudies presented project implementation and the pharmacovigilance management plan. Attending experts expressed considerable interest in this new biological medicine independently designed and developed in China. They asked the sponsor about earlier development and actively discussed operational details and trial precautions.
Efsubaglutide alfa, also called Dabigang (达必刚), is China's first domestically developed, independently patented, human-derived, long-acting GLP-1 medicine for type 2 diabetes (T2DM) and related metabolic diseases. It promotes insulin secretion and pancreatic β-cell regeneration and improves β-cell quality, addressing both symptoms and underlying causes. It entered Phase III development in 2021. Compared with benchmark medicines in the same class, it has stronger efficacy, good tolerability and fewer side effects; study results show strong glucose lowering. The successful Phase III investigator meeting increased participants' confidence and enthusiasm. Innogen will work closely with investigators at all centers to complete the study efficiently and to a high standard, in strict accordance with the latest regulations. It aims to accelerate the medicine's route to market so that people with diabetes can gain earlier access to an innovative treatment with greater safety, better clinical efficacy and good value, contributing to the Healthy China strategy.
According to the Annual Report on the Status of Clinical Trials for New Drug Registration in China (2020), published by the NMPA's Center for Drug Evaluation, fewer than half of the trials registered in 2020 began recruitment within one year of approval (45.4%), indicating room to improve implementation efficiency after trial authorization in China.
With coordinated efforts by Innogen and its CRO, this study received human-genetic-resources authorization shortly after the lead institution's ethics approval and activated its first center promptly. Within two months of the first center opening, 50% of centers had been activated; within another two months, the total reached 90%. In December 2021, the study completed enrollment for the interim analysis, meeting its recruitment plan efficiently and achieving what the company called ‘Innogen speed.’
About Innogen
Founded in 2015, Innogen is an international pharmaceutical research, development and manufacturing company driven by technology and innovation. It focuses on biological medicines for diabetes and metabolic diseases. Its core management team combines recognized Chinese and international diabetes and endocrinology specialists, experienced drug-development experts and multidisciplinary business leaders. Its technology platform supports genetically engineered recombinant-protein biological medicines and manufacturing. It has several new medicines and technologies for diabetes and metabolic disease with global intellectual property, and internationally advanced capabilities in translational medicine for diabetes.