Novo Nordisk Launches China's First and Only Insulin GLP-1 RA Combination Injection, Xultophy® (Insulin Degludec/Liraglutide)

Novo Nordisk announced today the launch of NovoMix, the world's first basal insulin GLP-1RA injection.^®(Insulin Degludec and Liraglutide Injection) Officially Launched in China. NovoMix^®For adult patients with type 2 diabetes mellitus (T2DM) who have poor blood glucose control, to be used in combination with other oral hypoglycemic agents on the basis of diet and exercise to improve blood glucose control.¹Clinical evidence shows that the glycated hemoglobin (HbA1c <7%) achievement rate of insulin degludec and liraglutide injection can be as high as 89.9%.¹², and has been included in the "Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)"², helping patients achieve high-standard blood glucose management.

"As the world's first launched and China's only approved basal insulin GLP-1RA injection, NovoMix^®Combining the advantages of both degludec insulin and liraglutide components, with complementary mechanisms, targeted regulation, and each independently exerting hypoglycemic effects.^3,4"Directly targets the root cause of T2DM pathogenesis, simultaneously improving insulin resistance and β-cell dysfunction." NovoMix^®The leading expert of the clinical research registered in China, Professor Wang Weiqing, Director of the Department of Endocrinology and Metabolism at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, stated, "Novo Nordisk^®Is a new drug that meets the treatment needs of Chinese T2DM patients, and it is expected to create a new situation of high standards for T2DM patient management, optimizing diabetes treatment decisions.

The World's First Basal Insulin GLP-1RA Injection: NovoMix^®Officially Launched in China

Multi-target Regulation, "Enhancing Efficacy and Reducing Side Effects", Glycated Hemoglobin Achievement Rate Reaches New High

The number of Chinese adults with diabetes is approximately 140 million, ranking first among all countries globally.^5,6, but the overall blood glucose control rate is only 16.5%.⁶. The target achievement rate for patients treated with oral hypoglycemic agents alone is about 35%.⁷, the patient compliance rate after basal insulin treatment is about 40%.⁸In addition, there are still some problems with existing diabetes treatment options, such as the potential risk of hypoglycemia and the possibility of weight gain, among others.

"I am very pleased to see that, in terms of balancing efficacy and safety, Novo Nordisk^®As the world's first basal insulin GLP-1RA injection, it can meet clinical needs well." NovoMix^®Leading expert of the China-registered clinical study, Professor Mu Yiming, Director of the Endocrinology Department at the First Medical Center of the PLA General Hospital, stated, "First, from the perspective of mechanism of action, NovoMix^®The two components - insulin degludec and liraglutide - act independently and complementarily on insulin receptors and GLP-1 receptors in multiple target organs, exerting a synergistic hypoglycemic effect.^9,10,11, the proportion of patients achieving glycated hemoglobin target (HbA1c<7%) reached a breakthrough 89.9%12, and the Time in Range (TIR) was as high as 90%.¹³Moreover, the common side effects of single-component therapy can offset each other, improving blood glucose control while reducing the adverse effects of insulin treatment on hypoglycemia and weight.^13,14,15,16". This shows that the clinical effect of insulin degludec liraglutide injection is 1+1>2, which can comprehensively enhance efficacy and reduce 'side effects'."

Globally Evidence-Based, Suitable for the Entire Course of Treatment, Safely Achieving High Standards

The global phase 3 clinical trial program (DUAL series studies) for insulin degludec/liraglutide injection has been completed. The DUAL series studies confirmed that, regardless of prior OAD treatment, prior GLP-1RA treatment, or inadequate glycemic control with prior basal insulin therapy in T2DM patients, the combination or switch to insulin degludec/liraglutide injection demonstrated consistent clinical efficacy and safety. Particularly, the results of the DUAL VI study showed that in the group adjusting the dose of insulin degludec/liraglutide injection once weekly, after 32 weeks of treatment, the mean reduction in HbA1c reached 2.0%, the proportion of patients achieving HbA1c <7% was 89.9%, and the proportion of patients achieving HbA1c <7% without hypoglycemia was 85.7%12. This not only confirms the effectiveness of Novo Nordisk's Xultophy.^®The high target achievement rate of treatment also confirms that the high target is achieved without compromising hypoglycemia, ensuring safe achievement.

Figure: Novo Nordisk^®Achieved drug accessibility in multiple provinces and cities across China

In addition to traditional indicators such as HbA1c, fasting blood glucose, and postprandial blood glucose, Time in Range (TIR) has emerged as a new metric for blood glucose control. Results from the global clinical trials of Novo Nordisk's Xultophy® demonstrate high target achievement rates, largely due to effective control of blood glucose throughout the day. In the DUAL VIII study, at the end of treatment, the average TIR in the insulin degludec/liraglutide group reached 90%, with a higher proportion of patients achieving TIR ≥70% compared to the insulin glargine U100 group.¹⁷。

Zhang Kezhou, Corporate Vice President of Medicine and Quality at Novo Nordisk Greater China, pointed out: "The pathogenesis of diabetes is complex, and Novo Nordisk..."^®Unique mechanism of action, as an innovative hypoglycemic drug, it no longer targets a single point but represents a multi-target treatment approach. It is a breakthrough fusion of the dual-component advantages of degludec insulin and liraglutide, with complementary mechanisms and multi-target effects on various pathophysiological mechanisms of diabetes, effectively controlling blood glucose throughout the day with once-daily dosing.

Charlotte Zhou, Senior Vice President of Novo Nordisk Global and President of Greater China, said: "Novo Nordisk upholds its century-old original aspiration and never stops innovating. NovoMix^®"It is the world's first basal insulin GLP-1 receptor agonist injection, and its launch represents another breakthrough innovation by Novo Nordisk in the field of diabetes treatment, demonstrating our commitment to doctors and patients with type 2 diabetes in China. In the future, our pace of innovation and collaboration will only accelerate, benefiting more Chinese diabetes patients by helping them achieve disease prevention, early diagnosis, early treatment, and effective control. We are fully committed to transforming diabetes and other serious chronic diseases in China, supporting the achievement of goals outlined in the 'Healthy China 2030' plan."