The Zhitong Finance App is OK. On April 10, the official website of the Drug Evaluation Center of the State Drug Administration announced that the clinical trial application for Novo Nordisk's Class 1 new drug amycretin tablets was accepted. According to Novo Nordisk's 2023 annual report, amyCretin is a long-term combination agonist of oral GLP-1 receptor and insulin receptor, and is a next-generation weight loss therapy. In the phase 1 clinical study, patients lost 13.1% of their body weight after 12 weeks of treatment with this product (vs. 1.1% in the placebo group), showing rapid weight loss effects and good clinical application potential.

Novo Nordisk's leading weight loss drug is simeglutide. The injectable dosage may be approved for weight loss in China within this year. According to previously published test data, during the 68-week trial period, the simeglutide injection group lost 14.9% of body weight and 6% of body weight at 12 weeks. In contrast, obese patients who took amycretin orally lost approximately 13.1% of their body weight after 12 weeks.

Regardless of factors such as enrollment conditions or dosage, amycretin's weight loss effects and ease of oral administration are superior to simeglutide injections. According to public reports, in March of this year, Novo Nordisk CEO Lars Rebien Sorensen also publicly stated that this diet pill under development may become the best drug of its kind to treat obesity.

As a representative of GLP-1 drugs, simeglutide has been commercially successful. Novo Nordisk's 2023 earnings report shows that sales of the slimming version of Simeglotide Wegovy soared 406% to US$4.6 billion, far leading the global GLP-1 circuit.

Currently, GLP-1 drugs occupy leading positions in the world in terms of diabetes and diet medicine layouts, Eli Lilly and Novo Nordisk. Novo Nordisk's simeglutide is the world's first major GLP-1 drug with sales exceeding $10 billion. Eli Lilly's tiverbotide is the world's first GIPR/GLP-1R dual agonist.

It is worth mentioning that the Chinese patent for liraglutide has expired, and some Chinese companies have submitted listing applications; the Chinese patent for simeglutide will expire in 2026. This means that domestic companies are expected to catch up with industry leaders.

On April 3, the official website of the National Drug Administration (NMPA) Drug Evaluation Center (CDE) showed that the marketing application (NDA) for the Jiuyuan Gene simeglutide injection biosimilar (JY29-2) was accepted, which also became the first domestic simeglutide to be declared for marketing. Huadong Pharmaceutical is the single largest shareholder of Jiuyuan Gene. In January of this year, Jiuyuan Gene also submitted a prospectus to the Hong Kong Stock Exchange to begin an IPO.

Currently, many domestic pharmaceutical companies such as Cinda Biotech, Hanyu Pharmaceutical, Livingzhu Group, and Huadong Pharmaceutical are already developing the generic drug market for simeglutide. Among GLP-1 products approved in China, Renhui Biotech's benaglutide and Huadong Pharmaceutical's liraglutide biosimilar have also been approved for the treatment of obesity in addition to diabetes treatment.

According to data from the Nomura Orient International Securities Research Report, the domestic GLP-1 industry is about to enter the harvest period, and the market size of sugar reduction+weight reduction is expected to reach 100 billion yuan in 2030. GLP-1's market space for the three indications of diabetes, overweight, and obesity is expected to reach 43 billion yuan, 15 billion yuan, and 43 billion yuan respectively, which is huge.

Guohai Securities believes that the Blue Ocean market for weight loss drugs is vast. With Novo Nordisk and Eli Lilly's trend in the development of GLP-1 targeted weight loss drugs, the weight loss drug industry ushered in a period of breakthrough achievements. Optimistic about investment opportunities brought about by the dual trend of “R&D breakthroughs and approval for marketing+consumer commercialization” of weight loss drugs, it is recommended to focus on relevant targets where weight loss drug research and development is progressing rapidly, while also focusing on related targets such as formulations, APIs, CDMO, and drug delivery devices in the industrial chain.

Related concept stocks:

Fosun Pharmaceutical (02196): On October 17 of last year, Fosun Pharmaceutical stated on an interactive platform that the company is currently developing liraglutide (intended for use in diabetes and obesity) in China, respectively, in phase III clinical trials.

Cinda Biotech (01801): In early February, Cinda Biotech announced that the marketing application for the first new drug for weight loss was officially accepted by the China Drug Administration for long-term weight control in adult obese or overweight patients.

Federal Pharmaceuticals (03933): Sino-Thai International previously stated that the company's management indicated that the first GLP-1 agonist, liraglutide, has submitted a marketing application and is expected to be approved for listing within 2024. Furthermore, according to current progress, the company expects the long-acting insulin Tokugu Insulin to be approved for marketing in 2025. According to the bank, the company is one of the first listed companies in Hong Kong to be approved for clinical trials with simeglutide. Since simeglutide has excellent effects in reducing sugar and weight loss, it will receive financial attention if future clinical data is good.

East China Pharmaceutical (000963.SZ): For GLP-1 targets, the company has established 8 products covering oral and injectable dosage forms, including long-acting and multi-target global innovative drugs and biosimilar drugs, involving indications such as weight loss, NASH, fat loss, CKD, etc., and is one of the pharmaceutical companies with the most comprehensive layout of GLP-1 targets in China.