On April 10th, the official website of the Drug Evaluation Center (CDE) of the National Medical Products Administration of China announced that the clinical trial application for the Class 1 new oral weight loss drug Amycretin tablets submitted by Novo Nordisk has been officially accepted.
Amycretin is another heavyweight loss therapy developed by Novo Nordisk, following Smegglutide. It is a novel oral GLP-1 receptor and Amylin receptor long-acting co agonist. A small Phase 1 clinical study recently released by Novo Nordisk showed that after 12 weeks of treatment with the drug, patients experienced an average weight loss of 13.1%, surpassing the weight loss efficacy of the old version of the semaglutide medication taken in the same cycle by 6%.
Novo Nordisk stated at last month's annual investor meeting that the mid-term trial of the drug will begin in the second half of this year and is expected to yield results in early 2026.
After the huge success of GLP-1 drugs, several companies are currently developing other promising new weight loss therapies, such as Amycretin, which targets amylin in the pancreas, which affects hunger. Similar to GLP-1, amylin can also slow down gastric emptying and promote satiety.
In addition to Novo Nordisk, another pharmaceutical company, Zealand, also has two pancreatic amyloid therapies under development. The company is also collaborating with German pharmaceutical company Boehringer Ingelheim to develop weight loss drugs.
Van Lanschot Kempen, a Dutch securities firm, believes that amyloid analogues are a "differentiated asset" in the weight-loss drug industry and can provide therapies tailored to different mechanisms.
On the other hand, oral versions of weight loss drugs have more advantages from the perspective of improving patient compliance. Novo Nordisk already has advantages in the development of oral therapies. In January this year, Novo Nordisk Megglutide Tablets was approved by the National Drug Administration (NMPA) for marketing. It is the first oral GLP-1 (glucagon like peptide-1) receptor agonist approved for marketing in China, which is used to treat adult type 2 diabetes.
At present, the oral preparation of Smegglutide for weight loss indications has entered phase 3 clinical trials in China, evaluating the efficacy and safety of 50mg oral preparation once daily in overweight or obese adults in China.
It is worth noting that the patent for Smegglutide compound in China will expire in 2026. On April 3rd, the official website of the Drug Evaluation Center of the National Medical Products Administration showed that Hangzhou Jiuyuan Genetic Engineering Co., Ltd.'s application for the listing of "Jiyoutai" injection of Smegglutide was accepted, making it the first Smegglutide biosimilar drug in mainland China to apply for listing.
In this context, Novo Nordisk's clinical application for the new generation GLP-1 class of drugs in China will help the company maintain its market advantage even after the expiration of the patent for Smegglutide.
Novo Nordisk also expects that the Wegovy injection, which is used for weight loss indications, is expected to be approved for sale in mainland China this year.
With Smegglutide, the market value of Novo Nordisk has exceeded $560 billion, surpassing Tesla's market value. The reason why GLP-1 drugs have ignited the capital market is because of their broader application prospects.
According to the latest research results published in the New England Journal of Medicine (NEJM) last Saturday, such hypoglycemic drugs can also reduce the risk of heart failure of diabetes patients with obesity related ejection fraction retention.