Recently, the National Medical Products Administration (NMPA) officially approved the marketing application of Novogene® (insulin smegglutide injection) in China. Novogene® is the world 's first and currently only approved basal insulin/glucagon-like peptide-1 receptor agonist (GLP-1RA) weekly formulation. It consists of the world's first insulin weekly formulation, insulin smegglutide, and the globally widely used GLP-1RA weekly formulation, smegglutide[1]. It is suitable for adult patients with type 2 diabetes whose blood glucose control is poor after basal insulin or GLP-1RA treatment, and is used in combination with oral hypoglycemic drugs on the basis of diet and exercise [2] .

Multidimensional blood glucose management and

Patient treatment adherence remains high in type 2 diabetes.

Key challenges in treatment

﹀

There are approximately 589 million adults with diabetes worldwide, of whom more than 90% have type 2 diabetes [3] . Insulin therapy is the cornerstone of diabetes management [4] , but in clinical practice, insulin therapy still faces many challenges—the risk of hypoglycemia, weight gain, and the treatment burden of daily injections may affect patients' glycemic control and adherence [5-9] . In recent years, with the development of relevant clinical research, the management concept of type 2 diabetes has gradually shifted from "glycemic control-centered" to "patient-centered", and treatment plans need to comprehensively consider glycemic efficacy, safety, and adherence [10,11] .

Complementary mechanisms, taking into account

Fasting and postprandial blood glucose

﹀

Novogene® is a combination formulation of insulin icotin and smegglutide. Its mechanism of action is the synergistic effect of its two single components. The formulation retains and integrates the pharmacological effects of each single drug component [ 1] - insulin icotin provides continuous and stable basal insulin coverage to control fasting blood glucose; smegglutide regulates insulin and glucagon secretion in a glucose-dependent manner, delays gastric emptying, and improves fasting and postprandial blood glucose [12-14] . In addition, smegglutide can reduce energy intake by suppressing appetite and delaying gastric emptying, thereby achieving weight management [15,16] .

"High-quality standards met" * , multiple benefits

﹀

The two components of Novogene® , basal insulin and GLP-1RA, work together to enhance efficacy while reducing the risk of weight gain and hypoglycemia associated with insulin therapy [11] . Studies have shown that in adult patients with type 2 diabetes who were already on basal insulin therapy, the Novogene® group achieved HbA1c <7% twice as high as the basal insulin group (72% vs 36%); the incidence of hypoglycemia*# was 78% lower than that of basal insulin ** , and there was a clear weight gain †† ^ ; the proportion of patients achieving “high-quality target achievement” * in the Novogene® group was as high as 55.7%, five times that of basal insulin ** [17,18] . In addition, Novogene® is administered once a week, which reduces the number of injections compared to daily insulin formulations, helping to improve patient compliance [1,18,19] .

Furthermore, the smegglutide component of Novogene® has pleiotropic effects [20-30] , potentially helping to improve other metabolic risk factors in adults with type 2 diabetes in addition to glycemic control. Additional analyses of the COMBINE 1 and COMBINE 3 studies showed that patients treated with Novogene® experienced improvements from baseline in waist circumference, blood pressure, and lipid profiles, with greater magnitudes of improvement compared to insulin therapy †† [17,18] .

In summary, Novogene® , administered once weekly, effectively lowers blood sugar and, compared to insulin therapy †† , provides clear weight gain benefits, reduces the incidence of hypoglycemia *# , and improves metabolic risk factors. These results suggest that Novogene® may offer multiple benefits to adult patients with type 2 diabetes.

picture
Professor Ji Linong of Peking University People's Hospital stated that combination therapy is an important treatment strategy for type 2 diabetes. The complementary mechanisms of basal insulin and GLP-1RAs not only enhance blood glucose lowering effects but also reduce the risk of weight gain and hypoglycemia that may result from using insulin alone. To further simplify treatment, Novogene®, the world's first innovative weekly basal insulin/glucagon-like peptide-1 receptor agonist formulation, was developed . Novogene® balances efficacy, safety, and convenience, providing patients with multiple clinical benefits and offering a new option for combination therapy. "There's a Chinese idiom, 'like a tiger with wings.' If we consider the weekly insulin Icosine as the 'tiger,' then the weekly GLP-1RA formulation smegglutide is the 'wings' that help it soar. Novogene® is truly a 'tiger with wings.'"

picture
Dr. Zhang Kezhou, Vice President of Pharmaceuticals and Quality at Novo Nordisk Greater China, stated, “The approval of Novogene® is thanks to the contributions of every researcher and participant in the clinical trials. The COMBINE 1 study was also the first international multicenter clinical trial in Novo Nordisk's history to have a Chinese expert as the global principal investigator, demonstrating the leadership and influence of Chinese experts in the global academic field. Novogene® fully embodies a patient-centered R&D approach and treatment philosophy, innovatively combining Novo Nordisk's two breakthrough molecules, insulin icoside and smegglutide, with a synergistic mechanism to powerfully lower blood sugar while further simplifying treatment, once a week, helping more adult patients with poorly controlled basal insulin levels achieve ‘high-quality target achievement’ * .

picture
Dr. Cai Yan, Senior Vice President of Marketing, Medical and Regulatory Affairs at Novo Nordisk International Operations, stated, “We are grateful to the National Medical Products Administration and relevant government departments for their strong support and guidance in accelerating the simultaneous approval of innovative drugs in China and globally. Novogene® is another significant achievement of Novo Nordisk’s ‘China Co-creation’ program, driving simultaneous global innovation and leading the rapid development of weekly insulin therapy formulations in China. For over a century, Novo Nordisk has led research and innovation in the fields of diabetes and obesity. For more than 30 years in China, we have consistently adhered to the ‘patient-centered’ philosophy, accelerating the introduction of innovative drugs and continuously improving drug accessibility. The approval of Novogene® in China makes China the first country globally to commercially launch it, demonstrating our long-term commitment to China and enabling Chinese adults with type 2 diabetes to benefit from innovative global treatment options sooner.”
https://mp.weixin.qq.com/s/VAf5lcU4Dio108n7bSNefA