The NMPA’s Center for Drug Evaluation (CDE) recently accepted the marketing application for Innogen’s first drug candidate, efsubaglutide alfa. The application covers monotherapy for type 2 diabetes inadequately controlled with diet and exercise, and combination treatment for type 2 diabetes inadequately controlled with metformin. More than 110 research centres and over 1,100 people with type 2 diabetes contributed to the two studies.
Efsubaglutide alfa is Innogen’s internally developed GLP-1 receptor agonist. The company anticipated that, if approved, it could become China’s first human long-acting GLP-1 receptor agonist with independently owned intellectual property, benefiting more patients with diabetes.
It had completed two Phase III trials: monotherapy in people whose glucose remained inadequately controlled after diet and exercise, and combination therapy in those inadequately controlled on metformin.
Efsubaglutide alfa efficacy results
— In the Phase III monotherapy study, HbA1c fell by 1.73 percentage points from baseline after 24 weeks with 1 mg weekly and by 2.15 points with 3 mg weekly, significantly more than placebo (P<0.001). The effect began rapidly: HbA1c had fallen by 1.1 points after four weeks.
— In the Phase III combination study, efsubaglutide alfa 3 mg weekly with metformin reduced HbA1c by 1.8 percentage points from baseline, a statistically and clinically significant result (P<0.001).
Safety and tolerability of efsubaglutide alfa
Fifty-two-week safety data from both Phase III studies showed no severe hypoglycaemia. The most common adverse reactions were gastrointestinal, mostly mild or moderate and transient.
Professor Qinghua Wang, Innogen’s founder, Chairman and General Manager, called the CDE’s acceptance a major milestone and recognition of its translational capabilities. He said: ‘We will actively advance efsubaglutide alfa towards commercialisation and continue innovative drug research in diabetes and metabolic disease. We also plan international R&D and commercial operations, based in China and seeking to provide best-in-class and first-in-class medicines to patients worldwide.’
Beyond type 2 diabetes, Innogen was developing efsubaglutide alfa for weight loss and non-alcoholic fatty liver disease to address substantial unmet treatment needs.
About Innogen
Innogen is a science-driven biotechnology company seeking to provide innovative, accessible, affordable and high-quality medicines for people with metabolic diseases. It has multiple internally developed programs for diabetes, obesity and non-alcoholic steatohepatitis, with global patents, and plans to expand research, development and commercial activity internationally.
Application and indication names in the English source
The company’s English body specifically calls the accepted marketing submission a biologics license application (BLA), covering monotherapy after inadequate control with diet and exercise and combination treatment after inadequate control with metformin. It also specifically names NASH (nonalcoholic steatohepatitis) among indications under further development; the corresponding Chinese paragraph uses nonalcoholic fatty liver disease. Acceptance describes the application’s status at the time.