Original report · translated from Chinese
Shanghai Innogen Pharmaceutical Technology Co., Ltd. announced that its team had overcome the effects of the pandemic to enrol more than 1,000 patients in two Phase III clinical studies within ten months, marking an important clinical research milestone.
YN011-301, a multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of efsubaglutide alfa injection in people with type 2 diabetes inadequately controlled with diet and exercise, was led by Nanjing Drum Tower Hospital, affiliated with Nanjing University Medical School, with Professor Dalong Zhu as lead principal investigator. YN011-302, a multicentre, randomised, double-blind, placebo-controlled efficacy and safety study in people whose type 2 diabetes was inadequately controlled with metformin, was led by Shanghai Sixth People's Hospital, affiliated with Shanghai Jiao Tong University. Its lead principal investigator was Professor Weiping Jia, a member of the Chinese Academy of Engineering. Both programmes received valuable advice from leading medical experts in China and overseas, supporting their rapid progress.
Investigators at the clinical centres, the Innogen team and the contract research organisation worked together to overcome numerous difficulties during pandemic outbreaks in Shanghai and elsewhere, completing enrolment efficiently and demonstrating what the company calls ‘Innogen speed’.
The announcement describes efsubaglutide alfa injection as China's first domestically developed, independently owned human-derived long-acting GLP-1 medicine, with potential for treating type 2 diabetes and related metabolic diseases. It states that efsubaglutide alfa promotes insulin secretion and pancreatic beta-cell regeneration and improves beta-cell quality, giving it potential to address both manifestations and underlying causes of disease. Completion of Phase III enrolment brought the candidate one step closer to marketing, with the company anticipating that it would fill a gap in independently developed diabetes medicines in this class.
At the time of the announcement, Innogen had completed an interim analysis and had been invited to present at meetings of the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA). Oral presentations and electronic posters would cover interim efsubaglutide alfa results and findings from other pipeline programmes.
What NASH means
The source expands NASH as “non-alcoholic fatty liver.” NASH means non-alcoholic steatohepatitis, which involves inflammation and liver-cell injury as well as fat accumulation. The historical wording is preserved below.
The source describes efsubaglutide alfa as a glucose-lowering candidate permitted by China's drug regulator to enter clinical studies with injections every one to two weeks. It claims greater human homology and clinical suitability than comparable imported formulations, together with a wide safety window and good efficacy. It also describes pipeline programmes targeting NASH (non-alcoholic fatty liver), obesity, type 1 diabetes and anti-ageing.
About Innogen
Founded in 2015, Innogen is an international, innovation-driven pharmaceutical research and manufacturing company focused on developing and commercialising biological medicines for diabetes and metabolic diseases. Its core management team combines prominent Chinese and international diabetes and endocrinology specialists, experienced drug developers and multidisciplinary business operators. The company has a platform for genetically engineered recombinant protein development and production, several diabetes and metabolic disease drug candidates and technologies with global intellectual property, and internationally advanced capabilities in translational diabetes medicine.