On January 26th, Red Star Capital Bureau reported that according to the latest announcement on the official website of the National Medical Products Administration, Novo Nordisk's GLP-1 analogue, Megglutide Tablets, has been approved for its new drug listing application. This also means that the drug is currently the first domestically approved oral GLP-1 receptor agonist.
According to the National Medical Products Administration
According to Novo Nordisk's previous news, the clinical trial of oral smeglutide in China has ended, mainly for patients with type 2 diabetes. Therefore, the industry believes that the approved indication of oral smeglutide is type 2 diabetes, not weight loss.
Before the oral version, Novo Nordisk's Smeglutide injection was approved for marketing in 2021, which is also used to treat type 2 diabetes.
In addition, in June 2023, the Drug Evaluation Center of the National Medical Products Administration updated Novo Nordisk's information on the acceptance of the marketing application for Smegglutide Injection. Industry analysis generally believes that Smegglutide's application for marketing in China is related to weight loss indications.