Novo Nordisk Announces NMPA Approval of Once-Weekly Semaglutide Injection (Ozempic®) for Type 2 Diabetes in China

On April 29, Novo Nordisk announced that the National Medical Products Administration (NMPA) had approved the marketing application in China for NovoTherapy® (semaglutide injection), developed and manufactured by Novo Nordisk.

Ozempic® (semaglutide injection) is a novel long-acting glucagon-like peptide-1 (GLP-1) analogue developed by Novo Nordisk. It has currently been approved for marketing in 52 countries and regions, including the United States, Europe, Canada, and Japan.

Ozempic® has a half-life of 7 days, supporting once-weekly injection with stable plasma drug concentrations. The SUSTAIN trial series demonstrated that Ozempic®, whether used as monotherapy or in combination with other oral glucose-lowering agents or basal insulin, significantly reduced glycated hemoglobin (HbA1c) by up to 1.8%. Its glucose-lowering efficacy was significantly superior to that of placebo, sitagliptin, canagliflozin, dulaglutide, liraglutide, exenatide once weekly, and insulin glargine. In Chinese registration clinical trials, Ozempic® achieved an HbA1c target attainment rate of 86.1% in the Chinese population, demonstrating robust glucose-lowering efficacy. Furthermore, the SUSTAIN 6 trial showed that Ozempic® significantly reduced the risk of major adverse cardiovascular events (MACE) by 26% in patients with type 2 diabetes, while also significantly improving multiple parameters including body weight, blood pressure, and lipid profiles, thereby providing comprehensive cardiometabolic benefits for patients.

In January 2020, the cardiovascular indication for Ozempic® was approved by the U.S. FDA to reduce the risk of major adverse cardiovascular events in adult patients with type 2 diabetes and established cardiovascular disease.