After Novo Nordisk Smegglutide was approved for listing in China, several A-share companies have recently disclosed the clinical trial trends of Smegglutide Injection.
On February 5th, Lizhu Group announced that its holding subsidiary, New Beijiang Pharmaceutical, has received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, approving the use of Simeglutide Injection for weight management indication clinical trials in accordance with the technical requirements of biologically similar drugs.
On February 1st, Hanyu Pharmaceutical announced that it had received the "Acceptance Notice" from the National Medical Products Administration for the approval and issuance of the clinical trial application for Smegglutide Injection. Indications for this medication: As an adjunctive treatment for a low calorie diet and increased physical activity, it is used for weight management in adult patients who are obese or overweight and have at least one weight related comorbidities.
East China Pharmaceutical also disclosed on the interactive platform on January 31 that the company's Smeglutide injection diabetes indication has completed the clinical phase 3 subjects' enrollment, which is expected to be completed in 2024, and the company has not officially set up the project of Smeglutide oral preparation.
Looking overseas, yesterday, Novo Nordisk's major shareholder, Novo Nordisk Holdings, announced that it will acquire biopharmaceutical contract manufacturer Contilent in an all cash transaction, with a total corporate value of $16.5 billion in debt. As part of the transaction, Novo Nordisk will acquire three filling factories of Contalent from Novo Holdings with a prepayment of $11 billion, which will help increase the production capacity of its best-selling weight loss drugs Wegovy and Ozempic (both of which are products of Smegglutide).
Affected by this news, the US stock market of Novo Nordisk rose 4% last night; Another leading weight loss drug company, Lilly, also surged 5.77%, with both companies reaching historic highs in stock prices.
Today, A-share weight-loss drug concept stocks also saw a significant increase. As of the close, Borui Pharmaceuticals rose 16%, Puli Pharmaceuticals rose over 11%, and Jiankangyuan, Huadong Pharmaceutical, Lizhu Group and others saw significant gains.
At the end of 2022, due to its excellent therapeutic effect and the promotion of celebrities such as Musk, Smegglutide became a popular "weight loss miracle drug".
Nowadays, the weight loss market is rapidly expanding, and the Forward Industry Research Institute predicts that the market size of weight loss drugs in China will reach 15.3 billion yuan by 2030.
According to a report by Fangzheng Securities on February 2nd, the research and development enthusiasm for GLP-1 products, represented by Smegglutide, is still high. The accessibility of drugs and the necessity of long-term medication to avoid weight rebound are the main concerns.
At present, many domestic enterprises are actively conducting research on innovative drugs and generic drugs targeting GLP-1.
Among them, Hengrui Pharmaceutical has deployed oral small molecule GLP-1 receptor agonists and GLP-1/GIP dual target agonists; In the first phase III clinical study (GLORY-1) of Xinda Biologics GLP-1R/GCGR dual agonist Masalidomide in overweight or obese adult subjects in China, the primary endpoint and all key secondary endpoints were achieved; The GLP-1/GIP receptor dual agonist independently developed by Borui Pharmaceuticals has biological effects such as controlling blood sugar, weight loss, and treating NASH, demonstrating the potential for treating various metabolic diseases.
In terms of generic drugs, Qilu Pharmaceutical, Zhengda Tianqing, Huadong Pharmaceutical, Federal Pharmaceutical, Lizhu Pharmaceutical, Zhifei Biotechnology, and others are all in Phase II clinical trials.
As for other links in the domestic peptide industry chain, several listed companies have also laid out related businesses. There are a total of four registered domestic active pharmaceutical companies for Simeglutide: Tianji Biotechnology, Notai Biotechnology, Pai Peptide Biotechnology, and Jianxiang Biotechnology, all of which have been accepted; There are 14 Chinese pharmaceutical companies registered in the United States, including Hanyu Pharmaceutical, Kailaiying, and Sanuo.