Novo Nordisk Launches China's First GLP-1 Weekly Injection with Cardiovascular Indication – Ozempic® (Semaglutide Injection)
Novo Nordisk
Insulin Developer and Manufacturer
Beijing, China, August 14, 2021 — Novo Nordisk today announced that Ozempic® (semaglutide injection), China’s first and currently only once-weekly GLP-1 receptor agonist with cardiovascular indications®(Semaglutide Injection) was officially launched in China[i]. In April this year, Ozempic®Approved in China with a "dual indication" for improving glycemic control, as an adjunct to diet and exercise, in adults with type 2 diabetes mellitus whose blood glucose remains inadequately controlled despite treatment with metformin and/or a sulfonylurea, and for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and cardiovascular disease.
China's First Once-Weekly GLP-1 with Cardiovascular Indications: Nuohetai® (Semaglutide)®Officially Launched
Ozempic®Lead expert for the China-registered clinical trial,Professor Ji Linong, Director of the Department of Endocrinology, Peking University People's Hospital, stated:“The management of type 2 diabetes mellitus in China faces challenges such as low target achievement rates for glycemic control and comprehensive control of blood glucose, blood pressure, and blood lipids, a high prevalence of cardiovascular disease, and non-standardized treatment practices. If these clinical needs remain unmet, they will adversely affect patients' quality of life and clinical outcomes. NovoThia®The launch of is expected to address this dilemma, providing physicians and patients with more comprehensive diabetes treatment options. Ozempic®®Administered once weekly, it maintains stable plasma drug concentrations for up to 7 days post-injection, making it the currently marketed GLP-1 RA with the highest glycemic target attainment rate. Meanwhile, Ozempic®It can also better comprehensively manage multiple cardiometabolic parameters, including body weight, blood pressure, and blood lipids, reduce cardiovascular events, and help patients better achieve long-term management goals.”
1、Low Glycemic Target Achievement Rate Poses a Bottleneck, High Incidence of Cardiovascular Disease Raises Concerns
In China, the number of individuals with diabetes exceeds 129.8 million, of whom only 15.8% achieve target glycemic control. One in three patients with type 2 diabetes in China has cardiovascular disease. Studies indicate that more than half of patients with type 2 diabetes are overweight or obese, nearly half have dyslipidemia, and close to two-thirds have hypertension. Patients with diabetes frequently present with multiple cardiovascular risk factors, which significantly complicates comprehensive management. In the long term, glycemic control and cardiovascular outcomes must be managed concurrently.
Prof. Mu Yiming, Director of the Department of Endocrinology, PLA General HospitalIndicates:“For patients with type 2 diabetes mellitus, treatment should not be confined to targeting a single ‘point’ within metabolic abnormalities, but must instead address the ‘surface’ of comprehensive improvement across overall metabolic parameters. It is crucial to balance glycemic control with cardiovascular outcomes while holistically managing metabolic disturbances, including blood pressure, lipid profiles, and body weight. Early initiation of GLP-1-based therapies with established cardiovascular and metabolic benefits enables the interception of multiple risk factors at their source, thereby delaying the onset and progression of complications and improving long-term clinical outcomes. Furthermore, studies have demonstrated that, compared with Caucasian populations, Asian patients derive greater cardiovascular benefits from GLP-1 receptor agonist therapy.”
2. Long-acting, Potent, and Multi-effect: Addressing the Challenges of Long-Term Diabetes Management
Ozempic®®The landmark launch will robustly address unmet clinical needs in type 2 diabetes across multiple dimensions through a long-acting, potent, and multi-faceted therapeutic profile: with a half-life extended to 7 days enabling once-weekly dosing, it delivers safe and potent glycemic control, precise target attainment "on demand," and comprehensive cardiometabolic benefits. The global, multi-center, large-scale SUSTAIN clinical trial program enrolled over 11,000 patients, including 605 from China, confirming the superior glycemic efficacy, safety, and cardiometabolic benefits of semaglutide.
To date, among the glucose-lowering drugs approved or marketed in China, most require once-daily dosing.Zhang Kezhou, Corporate Vice President, Medical and Quality Departments, Novo Nordisk ChinaIndicates:“Ozempic®Based on the native human GLP-1 molecule, innovative peptide chain optimization facilitates tight binding to albumin and resistance to DPP-4-mediated degradation, thereby enhancing stability. This significantly extends the half-life to 7 days, enabling once-weekly dosing with stable plasma concentrations, while retaining up to 94% amino acid sequence homology with human GLP-1. Ozempic®®Administered once weekly, it simultaneously addresses glycemic control and cardiovascular protection, overcoming the complexity of most treatment regimens, significantly improving patient medication adherence, and helping to enhance patients' overall quality of life.”
In diabetes management, glycated hemoglobin (HbA1c) is the "gold standard" for reflecting glycemic control status, and achieving target levels is also a crucial measure for preventing and delaying complications. Results from the SUSTAIN China study demonstrate that in the Chinese population, semaglutide significantly reduces HbA1c by 1.8%, with an HbA1c target attainment rate (<7.0%) as high as 86.1%, alongside an extremely low incidence of hypoglycemia. Another semaglutide study indicates that it can significantly improve β-cell responsiveness in patients with type 2 diabetes to levels comparable to those in healthy individuals, enabling an "on-demand" reduction in HbA1c levels and effectively helping patients achieve precise glycemic control targets.
In recent years, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), characterized by significant glucose-lowering efficacy and multiple additional benefits, have steadily risen in prominence across major clinical guidelines. Both Chinese and international authoritative guidelines consistently affirm the pivotal therapeutic role of GLP-1 RAs in patients with type 2 diabetes who have established cardiovascular disease or are at high cardiovascular risk. Furthermore, a meta-analysis revealed that within the GLP-1 RA class, Asian patients derive a significantly greater benefit in reducing major adverse cardiovascular events (MACE) compared to Caucasian patients. Results from the SUSTAIN 6 trial demonstrated that, when added to standard therapy, semaglutide significantly reduced the risk of MACE by 26% and the risk of non-fatal stroke by 39% compared with placebo.
Zhou Xiaping, Senior Vice President, Global and President, Greater China at Novo Nordisk, said: “Glad that Ozempic®The launch of this groundbreaking innovative product in China has been made possible by the support and guidance of the National Medical Products Administration (NMPA) and relevant authorities in accelerating the introduction of innovative medicines into China. We sincerely thank the investigators and clinical trial participants for their contributions. We believe that Nuohetai®It will effectively address unmet medical needs, providing healthcare professionals and patients with type 2 diabetes with a more optimal comprehensive management solution. While improving glycemic target attainment rates, its multiple benefits will help patients return to a balanced and confident life. Moving forward, we will remain patient-centric, meet diverse treatment needs through continuous innovation, improve comprehensive diabetes management target attainment rates, continue our journey to transform diabetes care in China, and contribute to the realization of the goals outlined in the ‘Healthy China 2030’ Planning Outline.”
Novo Nordisk's digital patient service platform, the “NovoCare” mini program, has launched Rybelsus.®Exclusive Version for Use with Rybelsus®Provides patients with free tailored services such as disease education, disease management, and the "Convenient Pharmacy Map for Diabetes", helping patients establish a positive medication experience and enhance self-management.
# About Ozempic®(Semaglutide Injection)
Ozempic®(Semaglutide Injection) is a novel long-acting glucagon-like peptide-1 (GLP-1) analog developed by Novo Nordisk, which has been approved for marketing in 58 countries and regions, including the United States, Europe, Canada, and Japan.
Ozempic®With a half-life of up to 7 days, it is suitable for once-weekly injection and maintains stable plasma drug concentrations. The SUSTAIN clinical trial series demonstrated that, whether used as monotherapy or in combination with other oral antidiabetic drugs or basal insulin, Ozempic®can significantly reduce glycated hemoglobin (HbA1c) by up to 1.8%, with glucose-lowering efficacy significantly superior to that of placebo, sitagliptin, canagliflozin, dulaglutide, liraglutide, once-weekly exenatide, insulin glargine, and various other antihyperglycemic agents. In registration clinical trials in China, Ozempic®®In the Chinese population, the HbA1c target attainment rate was as high as 86.1%, demonstrating robust glucose-lowering efficacy. Meanwhile, the SUSTAIN 6 trial showed that Ozempic®®It can significantly reduce the risk of MACE by 26% in patients with type 2 diabetes, and significantly improve multiple clinical parameters including body weight, blood pressure, and lipid profiles, thereby providing comprehensive cardiometabolic benefits to patients.
About Novo Nordisk
Founded in 1923, Novo Nordisk is a global leading biopharmaceutical company headquartered in Denmark. Our goal is to drive change to defeat diabetes, obesity, rare blood disorders, endocrine diseases, and other serious chronic conditions. To achieve this, we drive scientific breakthroughs, expand access to our medicines, and are committed to the prevention and eventual cure of diseases. Novo Nordisk employs approximately 45,800 people across 80 countries and regions worldwide, providing products and services to 170 countries and regions globally. Novo Nordisk China Official Website:http://www.novonordisk.com.cn
Notes:
[i] As of August 14, 2021
[1] Yongze Li, et al. BMJ. 2020, 369 :m997.
[2] Wang L, et al. JAMA. 2017, 317(24):2515-2523.
[3] Hong Tianpei., et al. CAPTURE. GW-ICC 2020 Poster: GW31 –e1199.
[4] Ji L, Hu D, Pan C, Weng J, Huo Y, Ma C, Mu Y, Hao C, Ji Q, Ran X, Su B, Zhuo H, Fox KA, Weber M, Zhang D; CCMR Advisory Board; CCMR-3B STUDY Investigators. Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients. Am J Med. 2013 Oct;126(10):925.e11-22. doi: 10.1016/j.amjmed.2013.02.035. Epub 2013 Jun 27. PMID: 23810406.
[5] Lee MMY, et al. Diabetes Care. 2021 Mar 11.
[6] Linong Ji, et al. Diabetes Obes Metab . 2020 Oct 19. doi: 10.1111/dom.14232. Online ahead of print.
[7] Lee MMY, et al. Diabetes Care. 2021 Mar 11.
[8] Marso SP, et al. NEJM 2016; 375(19) 1834-1844.