Original report · translated from Chinese
On 31 May 2024, President Ruilin Song and Secretary-General Lan Feng of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) led a delegation to Innogen in Shanghai’s Zhangjiang Pharma Valley. Founder and Chairman Dr Qinghua Wang, Chief Commercial Officer Wenjie Xu, Chief Financial Officer Fan Jiang and other members of the management team welcomed the visitors.
The delegation toured Innogen’s Zhangjiang offices and heard Dr Wang describe the company’s beginnings, the development and registration history of its first pipeline product, efsubaglutide, and future commercialisation plans. Discussion covered the burden of diabetes, unmet market needs, innovative R&D, regulation and registration, intellectual property, pricing and market access. Mr Song commended the company’s research management and internationally minded team. He noted that diabetes is managed as a chronic disease in China and said Innogen’s innovation contributes to domestic development capabilities. He expressed the view that efsubaglutide offered progress in efficacy, safety and adherence that could benefit more Chinese patients. ‘Chinese pharmaceutical innovation needs more best-in-class medicines and more encouraging developments. We look forward to the launch of Innogen’s innovative medicine. Its research and commercial planning already take an international perspective, which matters for continued industry innovation,’ he said. He added that an innovative industry would encourage innovative regulation and that PhIRDA would continue working with government, industry and experts to advance innovation and closer links between clinical practice and R&D.
Dr Wang said Innogen’s development had benefited considerably from government support for biopharmaceuticals. He highlighted the company’s inclusion in the second annual Zhangjiang Life and Health Industry Emerging Companies list as further government and industry recognition of its technical capabilities and pipeline value. He noted increasing alignment of China’s drug-development and regulatory systems with international practice and more scientific, interactive communication between industry and government. He hoped both sides would deepen exchanges and cooperation, drawing on their respective strengths to support Chinese pharmaceutical innovation.
About Innogen
Innogen is a science-driven biopharmaceutical 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. The company reports renewed government and industry recognition of its scientific capabilities and pipeline innovation.
About efsubaglutide alfa
Weight observations from a drug-interaction study
These four-week weight observations came from a single-centre, open-label, fixed-sequence study in 31 participants without diabetes. The study evaluated how efsubaglutide alfa affected the pharmacokinetics of digoxin or metformin; eligible BMI was 20–28 kg/m². The weight observations alone do not establish efficacy as an obesity treatment.
Innogen’s first pipeline product, efsubaglutide alfa, had completed Phase III research in type 2 diabetes, and its marketing application had been accepted by the CDE. The article reports good safety and strong glucose-lowering efficacy: after 24 weeks, HbA1c fell by up to 2.2 percentage points with 3 mg monotherapy and up to 1.8 points with added metformin; reductions of approximately one point were seen after four weeks. It describes good long-term tolerability and a very low risk of hypoglycaemia. In weight-loss data from people without diabetes, efsubaglutide alfa with digoxin and efsubaglutide alfa with metformin produced four-week weight reductions of 5.4% and 7.0%, from baseline BMIs of 24.42 and 24.17 kg/m², respectively. The reported average loss was 4 kg. Overall, 71% achieved weight loss of at least 5%, including 80% in the metformin combination group. The article anticipated that, upon approval, the product could become China’s first humanised long-acting GLP-1 receptor agonist with independently owned intellectual property. Innogen was also developing weight-loss and non-alcoholic fatty-liver indications to address unmet needs.
Liver indication in the English source
In describing further efsubaglutide alfa development, the company’s English source specifically names nonalcoholic steatohepatitis, while the corresponding Chinese paragraph uses the broader term nonalcoholic fatty liver disease. These statements retain their 2024 reporting context.