The long-acting GLP-1 hypoglycemic drug "Semaglutide Injection" is about to be approved

On April 20th, the Insight review timeline showed that Novo Nordisk’s GLP-1 hypoglycemic drug "Semaglutide Injection" (ie Semaglutide Injection, acceptance number: JXSS2000006/7) has left the second The round of supplementary information task, today's review status changed to "pending approval", which means this type 2 diabetes drug will be approved in the near future.

From: NMPA; the review time axis is attached at the end of the article

Semaglutide injection (Semaglutide, English trade name: Ozempic) is a long-acting GLP-1 receptor agonist developed by Novo Nordisk.

At present, 6 types of GLP-1 receptor agonists have been approved for marketing in China, which are imported exenatide (normal + long-acting), liraglutide, risnatide, and dulaglutide; domestically produced benaru Peptide, polyethylene glycol loxenatide.

After semaglutide is approved in China, it will become the seventh GLP-1 receptor agonist in China.

On December 5, 2017, the FDA approved Ozempic (Semaglutide Injection) to aid diet control and exercise to improve blood sugar control in patients with type 2 diabetes.

On September 20, 2019, Novo Nordisk's somaglutide tablets were approved by the US FDA (specifications: 7 mg and 14 mg), with the trade name "Rybelsus".

At present, Novo Nordisk has two blockbuster drugs in the GLP-1 drug market, namely liraglutide, semaglutide injection and oral preparations.

According to the Insight database, Novo Nordisk's oral semaglutide is currently in the phase III clinical stage in China, and 4 clinical trials have been carried out.

From the Insight database (http://db.

Attachment: Timeline of review of semaglutide injection