Development status of the adolescent indication
This article concerns authorization for a Phase Ib clinical trial in adolescent obesity. On 28 July 2026, the company announced enrollment and dosing of the first participant. This is not marketing approval for adolescent obesity. Discussion of molecular design and immunogenicity does not replace clinical efficacy and safety results in this population.
First adolescent participant dosing announcement, 28 July 2026 ↗
Original report · translated from Chinese
Shanghai, China, 23 June 2026 — Innogen (2591.HK), a biopharmaceutical company focused on developing and commercializing innovative medicines for metabolic diseases, announced that the National Medical Products Administration (NMPA) has cleared a Phase Ib weight-loss trial of its independently developed long-acting GLP-1 receptor agonist, Efsubaglutide Alfa Injection, in adolescents aged 12–17 with obesity, or overweight accompanied by related complications. The trial is expected to begin in July 2026 and plans to enroll approximately 36 participants.
Childhood and adolescent obesity has become a global public-health challenge, with prevalence continuing to rise in China. The Report on Nutrition and Chronic Disease Status of Chinese Residents (2020) found overweight and obesity rates of 11.1% and 7.9%, respectively, among those aged 6–17, with obesity increasingly affecting younger children.1 Adolescent obesity contributes to metabolic conditions including type 2 diabetes, hypertension, fatty liver and polycystic ovary syndrome, while also substantially increasing the risk of depression, low self-esteem and social difficulties. Clinical research shows that obesity persists into adulthood in approximately 40%–80% of affected children, markedly increasing their long-term risk of cardiovascular and cerebrovascular disease.2,3 Policies including Healthy China 2030 and the Healthy Children Action Enhancement Plan (2021–2025) have made prevention and control of adolescent obesity a public-health priority.
No weight-loss medicines are currently approved in China for children or adolescents. Because adolescents are at a critical stage of growth and development, medicines must meet demanding safety requirements. For adolescents with obesity who have not responded to sustained lifestyle intervention and do not wish to undergo bariatric surgery, there is an urgent clinical need for medicines with both safety and established efficacy. This trial will systematically assess efsubaglutide alfa's safety, tolerability, pharmacokinetics and pharmacodynamics in adolescents with obesity. Its humanized design may offer lower immunogenicity than comparable recombinant-protein medicines, potentially addressing a longstanding unmet need and providing another option for clinicians and patients.
Efsubaglutide alfa is a human-derived, long-acting GLP-1 receptor agonist for which Innogen holds independent intellectual property in China and internationally. It acts through pathways shared with the GLP-1 class: modulating central appetite signals to increase satiety, delaying gastric emptying to reduce calorie intake, regulating insulin secretion in a glucose-dependent manner and increasing insulin sensitivity. These actions support simultaneous improvements in blood glucose, weight, blood lipids and liver lipids. Numerous preclinical animal models have demonstrated broader metabolic benefits. In animal models of diabetes, efsubaglutide alfa significantly reduced body weight, visceral fat and hepatic lipid accumulation, while lowering total cholesterol, low-density lipoprotein and triglycerides.
As a long-acting GLP-1 receptor agonist, efsubaglutide alfa has also shown good weight-loss effects and acceptable safety in adults with obesity. Its established mechanism and adult clinical weight-loss data provide a scientific basis for extending development to adolescents with obesity.
Efsubaglutide alfa, the company's core metabolic-disease product, is approved for adult type 2 diabetes in mainland China and Macau. Results from the Chinese Phase IIb ENLIGHT study in overweight and obesity were presented at the American Diabetes Association's 86th Scientific Sessions in 2026. After 18 weeks of treatment with 20 mg, including six weeks of titration and 12 weeks of maintenance, participants receiving once-weekly (QW) and once-every-two-weeks (Q2W) regimens lost 10.58% and 9.70% of baseline body weight, respectively. The weight loss was predominantly fat rather than muscle, increasing the muscle-to-fat ratio by 45.3% from baseline. MRI proton density fat fraction (MRI-PDFF) measurements also showed liver-fat reductions of up to approximately 52% from baseline after 18 weeks, indicating potential metabolic advantages beyond weight reduction through fat loss, muscle preservation and reduced hepatic fat deposition.
Global multicenter clinical development in obesity-related indications is progressing. The Australian Phase II trial is exploring a long-acting once-every-four-weeks (Q4W) regimen, extending the investigation of potential clinical uses.
Dr. Qinghua Wang, Innogen's founder, chairman and CEO, said that clearance of the adolescent weight-loss study is an important milestone in building a metabolic-disease pipeline across age groups. Building on the molecule's differentiated low-immunogenicity profile and its preclinical and adult weight-loss data, the company will advance adolescent clinical development efficiently. It aims to introduce a domestically developed long-acting GLP-1 weight-loss medicine suited to adolescents, support the Healthy China strategy, ease the public-health burden of adolescent obesity and strengthen its position in global metabolic-drug innovation.
References:
[1] Bureau of Disease Prevention and Control, National Health Commission. Report on Nutrition and Chronic Disease Status of Chinese Residents (2020). Beijing: People's Medical Publishing House; 2021.
[2] Bureau of Disease Prevention and Control, Ministry of Health of the People's Republic of China. Guidelines for the Prevention and Control of Overweight and Obesity in Chinese School-Age Children and Adolescents (trial edition). Beijing: People's Medical Publishing House; 2008:7–9.
［3］ Small L, Aplasca A. Child obesity and mental health: a complex interaction[J]. Child Adolesc Psychiatr Clin N Am, 2016, 25(2):269‑282. DOI: 10.1016/j.chc.2015.11.008
Note: Efsubaglutide alfa is currently approved for type 2 diabetes. Obesity and weight-loss indications remain under clinical investigation and are not approved for marketing. This content provides company R&D updates and industry information only; it does not constitute drug advertising, treatment advice or a promise of efficacy. Prescription medicines should be purchased with a physician's prescription and used under medical supervision.
About Innogen
Founded in 2014, Innogen (HK.2591) develops and commercializes innovative medicines for metabolic diseases. Its independently developed pipeline covers indications including type 1 diabetes (T1D), obesity, metabolic dysfunction-associated steatohepatitis (MASH) and Alzheimer’s disease (AD), with global intellectual property and patent coverage. Its core product, efsubaglutide alfa, is an independently developed, new-generation, human-derived, ultra-long-acting GLP-1 receptor agonist approved in mainland China and Macau for type 2 diabetes and included in the National Drug Reimbursement List for Basic Medical Insurance, Maternity Insurance and Work Injury Insurance (2025 edition). It has entered global development and registration, with the aim of providing better treatment options for patients worldwide. For more information, visit:
www.innogenpharm.com.