On November 10, the CDE website showed that Novo Nordisk's (Novo Nordisk) marketing application for the Class 1 new drug, camrelintide smegglutide injection, for long-term weight management, was accepted.
CagriSema is an investigational fixed-dose combination therapy consisting of the long-acting amylintide receptor agonist and the GLP-1 receptor agonist semagglutide, administered subcutaneously once weekly. The two components work synergistically through different and complementary mechanisms of action on pathways related to appetite and weight regulation.
In December 2025, Novo Nordisk submitted a New Drug Application to the FDA for CagriSema, which is designed to help obese or overweight adult patients lose weight and maintain the weight loss effect in the long term, especially for patients with at least one weight-related comorbidity, in conjunction with a low-calorie diet and increased physical activity.
Novo Nordisk stated that, if approved, CagriSema will be the first injectable combination of a GLP-1 receptor agonist and an amylin analogue. According to its latest financial report, Novo Nordisk plans to launch CagriSema in the United States in early 2027, pending regulatory approval.
The development of CagriSema for weight management is primarily driven by the REDEFINE global Phase III clinical program, which aims to evaluate the efficacy and safety of once-weekly subcutaneous injections of CagriSema for long-term weight management in overweight or obese adult patients. Key studies supporting the U.S. marketing application include REDEFINE 1 and REDEFINE 2, which respectively covered overweight or obese adults with and without type 2 diabetes.
This registration application in China is based on the REDEFINE global Phase III clinical development program, which includes the REDEFINE 6 registration study conducted in China. The REDEFINE 6 study was completed in February 2025, and the specific results have not yet been disclosed.
In the field of weight management, several GLP-1-related drugs have been approved: Smegglutide (Wegovy) and liraglutide (Saxenda) are single-target GLP-1 drugs, Zepbound is a dual-target GIP/GLP-1 drug, and Mastodextrin is a dual-target GLP-1/glucagon drug (currently approved in China). CagriSema is a fixed combination of a GLP-1 receptor agonist and an amylin receptor agonist; currently, there are no approved products with the same mechanism of action.

Source: https://www.moomoo.com/hans/news/post/1004431053?level=0&global_content=%7B%22promote_content%22%3A%22mm%3A1004431053%22%7D