Happy celebration! Guangzhou Innogen Pharmaceutical Group Co., Ltd.’s independently developed innovative drug Innogen® (isupaglutide α) has been approved for marketing!

Happy celebration! Guangzhou Innogen Pharmaceutical Group Co., Ltd.’s independently developed innovative drug Innogen® (isupaglutide α) has been approved for marketing!

Beijing, China, January 26, 2025 - The National Medical Products Administration (NMPA) has approved the marketing application in China of Guangzhou Innogen Pharmaceutical Group Co., Ltd. - independently developed Innogen ® (esupaglutide α injection) for the treatment of type 2 diabetes (T2D) in adults 1 . This is the world’s new generation of human-sourced ultra-long-acting GLP-1 drug! It is expected to open a new chapter in China's metabolic health treatment, help diabetic patients lower blood sugar faster, is expected to improve metabolism, has potential weight loss and cardiovascular benefits, does not require titration, and is easy to use 2 .

Blood sugar and weight management, it’s urgent!

my country has the largest number of diabetic patients in the world, with the number of adult diabetic patients reaching 148 million 3 , of which more than 60% are overweight or obese 4 . Today, people's lifestyles have changed, and the prevalence of overweight, obesity, and diabetes are rising rapidly 4 . Surveys show that nearly 40% of Chinese patients with type 2 diabetes have abdominal obesity 4 . By 2030, it is expected that the number of overweight and obese people will reach 610 million 5 , which is a big problem because overweight and obesity will increase the risk of diabetes, hypertension and other diseases, posing a serious threat to everyone's health, and measures must be taken to improve this situation 5 .

Healthy China Action is calling!

In order to respond to this challenge, the country launched the "Healthy China Action-Diabetes Prevention and Treatment Action Implementation Plan (2024-2030)", with the goal of ensuring that more than 70% of type 2 diabetes patients are under standardized management by 2030 5 . The latest "China Diabetes Prevention and Treatment Guidelines (2024 Edition)" emphasizes that weight and blood sugar management must be integrated. When selecting medications for overweight or obese patients with diabetes, it is recommended to select medications with weight loss effects 6 . The National Health Commission also issued the "Guiding Principles for Weight Management (2024 Edition)" which recommends that overweight or obese people should first lose weight through lifestyle intervention, such as eating a reasonable diet and increasing exercise. If you still cannot achieve your weight loss goals after adjusting your lifestyle, you may consider using drugs or surgery under the guidance of your doctor. The weight loss plan should be adhered to for a long time, such as losing 24kg per month, losing 5%15% of body weight within 6 months and maintaining it 7 . Existing treatments are not enough, and we need more new treatments to deal with this health problem.

Innovative drugs bring new hope!

The generic name of Yinuoqing ® "isupaglutide α" is named in accordance with the naming principles of the International Nonproprietary Name (INN) of drugs issued by the WHO (World Health Organization) and the common names of biological products in the "Chinese Pharmacopoeia". This name reflects the complexity and rigor of drug research and development, and also shows that it complies with international standards. This drug has a unique design and is a human-derived ultra-long-acting GLP-1 receptor agonist. It is connected through a unique natural hinge and a preferred IgG2 fusion protein, which makes it have a strong affinity for the GLP-1 receptor. It is degraded by hydrolases and filtered by the kidneys more slowly in the body. Its average half-life in T2D patients is as long as 204 hours. Moreover, it has a high degree of humanization and is produced in the mammalian cell line (CHO cells) that is currently the most widely used in macromolecular protein drugs. It has strong activity and low immunogenicity 1 , 8 .

Humanization and long-lasting effects are the current trends in GLP-1 drug development. Since natural GLP-1 has a short half-life in the human body and will be degraded quickly, the R&D team of Guangzhou Innogen Pharmaceutical Group Co., Ltd. used genetic engineering recombinant protein technology to solve this problem. Therefore, Innogen ® has a longer half-life than similar long-acting GLP-1 drugs.

Yinuoqing ® clinical research shows outstanding results, leading metabolic health

1. Blood sugar drops quickly and steadily

o Yinuoqing ® has a fast onset of action and good hypoglycemic effect. Treatment with a single dose of 3 mg for 4 weeks reduced patients' glycosylated hemoglobin (HbA1c) levels by 1.1%. After 24 weeks of treatment, HbA1c was significantly reduced by 2.2% from baseline 9 , and the reduction was also as high as 1.8% when combined with metformin 10 . For patients with baseline HbA1c <8.5%, the HbA1c target rate after 24 weeks of monotherapy can reach 81.5% 11 . Moreover, for patients with new-onset type 2 diabetes, the diabetes remission rate can reach 60% 3 months after stopping the drug, and the effect is really long-lasting 1 1 .

2. Healthy weight loss is more scientific

o In terms of weight loss, the clinical data performance of Innolight ® is also excellent. Studies have shown that non-diabetic people can lose 4 kg of weight by using exupaglutide α for 4 weeks, with a weight loss of 6.2%, and 71% of people can lose more than 5% of their weight 1 1 .

3. Improvement of blood pressure and blood lipids

o Two phase III studies showed that patients’ cardiometabolic risk-related indicators were improved after treatment with Innolight ®. For example, systolic blood pressure can be reduced by 4.09 mmHg, and blood lipid levels such as total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) have also been reduced 1 1 . This shows that Yinuoqing ® can not only help control blood sugar, but also improve blood pressure and blood lipids, and reduce the risk of cardiovascular disease. In addition, the comprehensive metabolic compliance rate of Yinuoqing® can reach 31.4%, which is very helpful in reducing the occurrence of cardiovascular diseases 1 1 .

4. No need for titration, more convenient

o No drug-related severe hypoglycemia occurred with Innolight ® during the trial. The most common adverse reactions were gastrointestinal reactions, but these were mild or moderate. The incidence of adverse events such as nausea and vomiting that can easily lead to drug withdrawal is also very low. Moreover, its dosing regimen is simple, does not require dose adjustment, is well tolerated, and can reach the target dose and complete automatic injection in one step 1 1 .

It can be seen that Yinuoqing®, a GLP-1 drug independently developed by Chinese people, has made significant progress in the field of diabetes treatment 9 .

What do the experts say?

Academician Jia Weiping from the Sixth People's Hospital of Shanghai Jiao Tong University is the principal investigator of the Indications Registration Study of Yinuoqing® combined with metformin in the treatment of type 2 diabetes in China (SUPER-2). : "Controlling blood sugar and weight is the key to managing type 2 diabetes. In China, more than 60% of diabetic patients are overweight or obese, which not only makes it more difficult to control blood sugar, but also increases the risk of complications. For these patients, weight loss is important to improve the metabolism of type 2 diabetes and help achieve comprehensive treatment goals. I believe that after Yinuoqing ® is launched in China, it can help more patients with type 2 diabetes control blood sugar and weight at the same time, opening a new chapter of 'metabolic health'."

Professor Zhu Dalong from Nanjing University School of Medicine's Drum Tower Hospital Affiliated to Nanjing University School of Medicine is the principal investigator of the registration clinical study (SUPER-1) of Yinuoqin® for single drug treatment of type 2 diabetes indications in China: "The Phase III clinical study of Yinuoqin ® in the Chinese population has achieved positive research results, bringing patients one of the fast, powerful, safe and convenient treatment options. After 20 years of painstaking research and development, Yinuoqin ® has been successfully approved this time. It is very exciting."

Dr. Wang Qinghua, founder, chairman and CEO of Guangzhou Innogen Pharmaceutical Group Co., Ltd.: "The approval of Innogen ® benefits from the support of the national science and technology 'Major New Drug Creation' project and the government's good policy of accelerating approval. We have been committed to developing innovative treatments for diabetes and other metabolic diseases. Innogen ® will help more patients live a ‘metabolically healthy’ life. We are also working hard to develop solutions for obese and overweight patients to ensure that they can receive appropriate treatment. Today, as metabolic diseases have become a public health burden, we are committed to working with the government and industry partners to fully support the multiple programs of the ‘Healthy China Action’ and jointly achieve the goal of ‘metabolic health’.”

About Yinuoqing ® (isupaglutide α)

The approved indications of Yinuoqing ® (isupaglutide α injection) are: suitable for the blood sugar control of adult patients with type 2 diabetes, including monotherapy (patients with poor blood sugar control through diet control and exercise alone) and combined treatment (patients with poor blood sugar control after receiving metformin treatment on the basis of diet control and exercise), with subcutaneous injection once a week. Biweekly clinical studies are already in preparation.

The generic name of Innogen ® "Isupaglutide α" was determined by the National Pharmacopoeia Commission in accordance with the naming principles of common names of biological products in the Chinese Pharmacopoeia (2020 Edition III) and the International Nonproprietary Names for Pharmaceutical Substances (INN) issued by the WHO. "I" represents the molecule containing the human immunoglobulin Fc domain, and "Supa" represents Guangzhou Innogen Pharmaceutical Group Co., Ltd.'s scientific research team, "glutide" represents a GLP-1 analog, and "α" represents glycosylated compounds (proteins/peptides).

About Guangzhou Innogen Pharmaceutical Group Co., Ltd.

Guangzhou Innogen Pharmaceutical Group Co., Ltd. is the first company in Asia and the third company in the world to advance the original human long-acting glucagon-like peptide-1 (GLP-1) receptor agonist to the registration and approval stage. Our core product issupaglutide α (trade name: Yinuoqing ® ) has entered the commercialization stage. As a science-driven and innovation-oriented biopharmaceutical company, we are at the forefront of developing innovative treatments for diabetes and other metabolic diseases. With our integrated, one-stop R&D, production and commercialization capabilities, we strive to become the world's leading biopharmaceutical company in the field of diabetic metabolic diseases.

Dr. Wang Qinghua, founder, chairman and CEO of Guangzhou Innogen Pharmaceutical Group Co., Ltd. and inventor of isupaglutide α, is a distinguished professor at Fudan University and the person in charge of the 13th Five-Year National Science and Technology "Major New Drug Creation" project.

Yinuoqing ® (Esupaglutide α Injection) is a prescription drug and should be purchased from regular channels with a prescription from a physician or other medical and health professionals with prescribing authority, and should be used safely and rationally under the guidance of a physician, pharmacist or other qualified medical and health professional.

This article is intended for communication by healthcare professionals only. Guangzhou Innogen Pharmaceutical Group Co., Ltd. does not recommend the use of unapproved drugs/indications.

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[1] Yinuoqing ® Instructions, the State Food and Drug Administration approved the listing of isupaglutide α injection, index number: XZXK-2025-123

[2] Chinese Medical Association Diabetes Branch. CDS2023 | Evidence-based leadership, focusing on prevention and optimal treatment! New evidence from China’s diabetes research unveiled at CDS2023. 2023-11-24.

[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 for patients with diabetes (2024 edition), Chinese Journal of Diabetes, 2024, 16(9): 959-971

[5] Notice on the issuance of the Healthy China Action-Diabetes Prevention and Control Action Implementation Plan (2024-2030)

[6] China Diabetes Prevention and Treatment Guidelines (2024 Edition), Chinese Journal of Diabetes, Volume 17, Issue 1, January 2025

[7] Notice from the General Office of the National Health Commission on the issuance of the Guiding Principles for Weight Management (2024 Edition)

[8] Isupaglutide α patent International application number: WOPCT /CN2023/101978

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

[10] Diabetes 2023;72(Supplement_1):7 78 -P

[11] China Medical Tribune Endocrinology Today. The new generation of ultra-long-acting GLP-1 drug Isupaglutide α checked into the CDS again, and multiple research results have attracted heated discussion! 2024-11-29.