On the afternoon of 25 September 2023, the session for the first presentation of clinical data at the 8th China Pharmaceutical Innovation and Investment Conference took place in Suzhou. Several investigational and new medicines featured at the session, with key results disclosed for the first time, attracting attention and positive feedback from investors and pharmaceutical professionals. Haiya Wu, Assistant Vice President and Head of Medical Affairs at Shanghai Innogen Pharmaceutical Technology Co., Ltd., presented 52-week Phase III efficacy and safety data for efsubaglutide alfa.
Independently developed by Shanghai Innogen Pharmaceutical Technology Co., Ltd., efsubaglutide alfa is a fusion protein linking GLP-1 and the Fc region of human immunoglobulin IgG2. Genetic engineering covalently joins the GLP-1 molecule to human IgG2 Fc through the immunoglobulin's natural hinge region. The source reports a longer half-life than comparable long-acting GLP-1 receptor agonists, averaging 204 hours. Phase III studies in type 2 diabetes had been completed, and the Center for Drug Evaluation had accepted the new drug application. The company expected the product, if marketed, to become China's first independently owned humanised long-acting GLP-1 receptor agonist and benefit more people with diabetes.
In the Phase III monotherapy study in type 2 diabetes, once-weekly doses of 1 mg and 3 mg reduced HbA1c from baseline by 1.73 and 2.15 percentage points, respectively, after 24 weeks, significantly more than placebo (P<0.001). Onset was rapid, with a reduction of 1.1 percentage points after four weeks. The proportions reaching HbA1c below 7% were 56% in the 1 mg group and 68% in the 3 mg group, compared with 15% on placebo. At week 24, fasting plasma glucose fell from baseline by 2.04 mmol/L and 2.49 mmol/L in the 1 mg and 3 mg groups, respectively, significantly more than placebo (P<0.001).
In the Phase III study of efsubaglutide alfa added to metformin in type 2 diabetes, the 3 mg group had a 1.8-percentage-point reduction in HbA1c from baseline at week 24, a statistically and clinically significant change (P<0.001). The proportion reaching HbA1c below 7% was 58%, significantly higher than in the placebo group (P<0.001).
The reported 52-week Phase III safety data showed favourable safety and tolerability, with no severe hypoglycaemia. The most common adverse reactions were gastrointestinal symptoms, mostly mild or moderate and transient.
About Innogen
Innogen is a science-driven biotechnology company committed to innovative, accessible, affordable and high-quality medicines for people with metabolic diseases. Its research pipeline includes diabetes, obesity and non-alcoholic steatohepatitis. All programmes are independently developed with global patents, alongside plans for international development and commercialisation.
Role and application wording in the English source
The company’s original English version identifies Haiya Wu as Vice President and Head of the Medical Department; the Chinese source identifies her as Assistant Vice President and Head of Medical Affairs. The English source also specifically calls the submission accepted by the CDE a biologics license application (BLA). These are differences in the source versions’ titles and terminology.