Innogen’s independently developed efsubaglutide alfa approved in mainland China for adult type 2 diabetes

Good news: Innogen's independently developed Diabegone® (efsubaglutide alfa) has been approved for marketing!

Beijing, China, 26 January 2025 — China's National Medical Products Administration (NMPA) has approved Innogen's independently developed Diabegone® (Efsubaglutide Alfa Injection) for marketing in China to treat adults with type 2 diabetes (T2D)¹. This is a new-generation, human-derived, ultra-long-acting GLP-1 medicine. It has the potential to open a new chapter in metabolic health in China by helping people with diabetes lower blood glucose more rapidly, with the prospect of improved metabolism and potential weight-loss and cardiovascular benefits. It requires no dose titration and is convenient to use².

Blood-glucose and weight management cannot wait

China has the world's largest population of people with diabetes, with as many as 148 million affected adults³, more than 60% of whom also have overweight or obesity⁴. Changes in lifestyle have accompanied rapid increases in overweight, obesity and diabetes prevalence.4 Surveys indicate that nearly 40% of people with type 2 diabetes in China have abdominal obesity.4 By 2030, the number of people with overweight or obesity is expected to reach 610 million.5 This is a substantial challenge: overweight and obesity increase the risk of diabetes, hypertension and other diseases, posing a serious threat to health that calls for action.5

A call to action from Healthy China

To address this challenge, China introduced the Healthy China Action Plan for Diabetes Prevention and Control (2024–2030), which aims to bring more than 70% of people with type 2 diabetes under standardized management by 2030⁵. The latest Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 edition) emphasize integrated management of body weight and blood glucose. When selecting medicines for people with diabetes who have overweight or obesity, they recommend medicines with weight-reducing effects⁶. The National Health Commission's Guiding Principles for Weight Management (2024 edition) recommend that people with overweight or obesity first seek weight loss through lifestyle interventions, including a balanced diet and increased physical activity. If these measures do not achieve the target, medication or surgery may be considered under medical supervision. Weight-management plans require sustained effort: for example, losing 2–4 kg per month, achieving a 5%–15% reduction in body weight within six months and maintaining that loss⁷. Existing treatments are insufficient; more treatment options are needed to address this health challenge.

An innovative medicine brings new hope

Diabegone®'s generic name, efsubaglutide alfa, follows the World Health Organization's International Nonproprietary Names (INN) system and the naming principles for biological products in the Chinese Pharmacopoeia. The name reflects the complexity and rigor of drug development and adherence to international standards. This human-derived, ultra-long-acting GLP-1 receptor agonist has a distinctive design: a natural hinge linkage and a selected IgG2 fusion-protein construct give it strong affinity for the GLP-1 receptor, while slowing degradation by hydrolytic enzymes and renal filtration. Its mean half-life in patients with T2D reaches 204 hours. It is also highly humanized and is produced in CHO cells, the mammalian cell line most widely used for large protein medicines, with high activity and low immunogenicity. 1,⁸.

Humanization and longer duration of action are current trends in GLP-1 drug development. Native GLP-1 has a short half-life in humans and is rapidly degraded. Innogen's research team addressed this challenge using genetically engineered recombinant-protein technology, giving Diabegone® a longer half-life than other long-acting medicines in its GLP-1 class.

Diabegone® clinical studies report strong results in metabolic health

1. Rapid, sustained blood-glucose reduction

• Diabegone® has a rapid onset and strong glucose-lowering effects. After four weeks of monotherapy at 3 mg, glycated hemoglobin (HbA1c) fell by 1.1 percentage points. After 24 weeks, HbA1c was significantly reduced by 2.2 percentage points from baseline⁹, with a reduction of up to 1.8 percentage points when combined with metformin¹⁰. Among patients with baseline HbA1c <8.5%, 81.5% reached the HbA1c target after 24 weeks of monotherapy¹¹. In addition, 60% of patients with newly diagnosed type 2 diabetes achieved diabetes remission three months after stopping treatment, indicating a lasting effect.11

2. A scientific approach to healthy weight loss

• Diabegone® also produced strong weight-loss results in clinical studies. Research showed that people without diabetes lost 4 kg, or 6.2% of their body weight, after four weeks of efsubaglutide alfa treatment; 71% achieved a reduction of at least 5%.11

3. Improvements in both blood pressure and lipids

• Two Phase III studies showed improvements in measures associated with cardiometabolic risk after treatment with Diabegone®. Systolic blood pressure fell by 4.09 mmHg, and lipid measures including total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) also declined.11 This indicates that, alongside blood-glucose control, Diabegone® can improve blood pressure and lipids and reduce cardiovascular disease risk. In addition, 31.4% of patients receiving Diabegone® met the combined metabolic targets, which can help reduce cardiovascular disease incidence.11

4. Convenience without dose titration

• No drug-related severe hypoglycemia occurred with Diabegone® in the trials. Gastrointestinal reactions were the most common adverse reactions, and all were mild or moderate. Events such as nausea and vomiting, which can lead patients to stop treatment, occurred at low rates. The dosing schedule is straightforward, with no dose adjustment required and good tolerability; the target dose can be delivered in a single automatic injection.11

These results indicate substantial progress in diabetes treatment with Diabegone®, a GLP-1 medicine independently developed in China.9

What do the experts say?

Academician Weiping Jia of Shanghai Sixth People's Hospital, affiliated with Shanghai Jiao Tong University, principal investigator of the Chinese registration study of Diabegone® with metformin for type 2 diabetes (SUPER-2): “Managing blood glucose and weight is central to type 2 diabetes care. More than 60% of people with diabetes in China also have overweight or obesity, which makes blood glucose harder to control and increases complication risks. For these patients, weight loss is important for improving metabolism in type 2 diabetes and helps achieve broader treatment goals. I believe the launch of Diabegone® in China will help more people with type 2 diabetes manage both blood glucose and weight, opening a new chapter in metabolic health.”

Professor Dalong Zhu of Nanjing Drum Tower Hospital, affiliated with Nanjing University Medical School, principal investigator of the Chinese registration study of Diabegone® monotherapy for type 2 diabetes (SUPER-1): “Phase III studies of Diabegone® in the Chinese population produced positive results, offering patients a treatment option with rapid, strong efficacy, safety and convenience. After 20 years of dedicated research and development, its approval is very encouraging.”

Dr. Qinghua Wang, Innogen's founder, chairman and chief executive officer: “The approval of Diabegone® benefited from support under the national Major New Drug Development program and favorable government policies accelerating review. We have long been committed to developing innovative therapies for diabetes and other metabolic diseases, and Diabegone® will help more patients live with better metabolic health. We are also working on solutions for people with overweight or obesity so that they can receive suitable treatment. As metabolic diseases become a public-health burden, we are committed to working with government and industry partners to support the Healthy China Action initiatives and pursue the shared goal of metabolic health.”

About Diabegone® (efsubaglutide alfa)

Diabegone® (Efsubaglutide Alfa Injection) is approved for blood-glucose control in adults with type 2 diabetes, as monotherapy for patients inadequately controlled with diet and exercise alone, and in combination with metformin for patients whose blood glucose remains inadequately controlled despite metformin, diet and exercise. It is administered by subcutaneous injection once weekly. A clinical study of administration once every two weeks is in preparation.

The Chinese Pharmacopoeia Commission determined the generic name efsubaglutide alfa for Diabegone® using the naming principles for biological products in Volume III of the Chinese Pharmacopoeia (2020 edition) and the WHO International Nonproprietary Names for Pharmaceutical Substances (INN) system. In the Chinese name, ‘依’ (yi) denotes a molecule containing a human immunoglobulin Fc domain; ‘苏帕’ (supa) identifies the compound developed by Innogen's research team; ‘格鲁肽’ (gelutai) denotes a GLP-1 analog; and ‘α’ (alfa) denotes a glycosylated compound, such as a protein or peptide.

About Innogen

Innogen is the first company in Asia and the third worldwide to advance an original, human-derived, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist to the registration and review stage. Our core product, efsubaglutide alfa (trade name: Diabegone®), has entered commercialization. As a science-driven, innovation-oriented biopharmaceutical company, we work at the forefront of innovative therapies for diabetes and other metabolic diseases. With integrated research, development, manufacturing and commercialization capabilities, we aim to become a leading global biopharmaceutical company in diabetes and metabolic disease.

Dr. Qinghua Wang, Innogen's founder, chairman and chief executive officer and the inventor of efsubaglutide alfa, is a distinguished professor at Fudan University and a project leader in the national Major New Drug Development program under China's 13th Five-Year Plan.

Diabegone® (Efsubaglutide Alfa Injection) is a prescription medicine. It should be obtained through authorized channels with a prescription from a physician or another healthcare professional with prescribing authority, and used safely and appropriately under the guidance of a physician, pharmacist or other qualified healthcare professional.

This article is intended for exchange among healthcare professionals only. Innogen does not recommend the use of unapproved medicines or indications.

¹

[1] Diabegone® product information; NMPA approval for marketing of Efsubaglutide Alfa Injection. Index number: XZXK-2025-123.

[2] Chinese Diabetes Society, Chinese Medical Association. CDS2023: Evidence-led prevention and treatment—new evidence from Chinese diabetes research presented at CDS2023. 24 November 2023.

[3] NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in diabetes prevalence and treatment from 1990 to 2022: a pooled analysis of 1108 population-representative studies with 141 million participants. Lancet. 2024;404(10467):2077-2093. doi:10.1016/S0140-6736(24)02317-1

[4] Expert consensus on weight management in patients with diabetes (2024 edition). Chinese Journal of Diabetes Mellitus. 2024;16(9):959–971.

[5] Notice issuing the Healthy China Action Plan for Diabetes Prevention and Control (2024–2030).

[6] Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 edition). Chinese Journal of Diabetes Mellitus. January 2025;17(1).

[7] General Office of the National Health Commission. Notice issuing the Guiding Principles for Weight Management (2024 edition).

[8] International patent application number for efsubaglutide alfa: WOPCT /CN2023/101978.

[9] Diabetes 2023;72(Supplement_1):757-P

[10] Diabetes 2023;72(Supplement_1):778-P

[11] China Medical Tribune—Today's Endocrinology. New-generation ultra-long-acting GLP-1 medicine efsubaglutide alfa returns to CDS, with multiple studies attracting discussion. 29 November 2024.