Text Wang Li Editor Xu Zhe Recently, the oral version of semaglutide "Novoxin" was approved for listing in China, which once leveraged the stock prices of A-share related industrial chain companies.
The "best miracle drug" that was popular all over the world is now available in an oral version, and "Novoxin" has also become the world's first approved oral GLP-1 (glucagon-like peptide-1) receptor agonist.
Affected by the news, on January 29, **concept stocks took the trend**. Among them, Jinkai Bioscience (30159SZ) opened more than 10% higher, and Haofan Bio (301393SZ), Changshan Pharmaceutical Co., Ltd. (300255SZ) and other open more than 5%, but the domestic approved indications are only *** type 2 diabetes, and do not involve weight loss indications, this wave of ** tide quickly extinguished, on January 30, ** drug concept stocks fell at the beginning of the day, Haofan Biology fell more than 10%, Changshan Pharmaceutical fell more than 7%, Hanyu Pharmaceutical (300199SZ), Jinkai Biosciences (301509SZ), Borui Pharmaceutical (688166SH) and so on.
Although the oral version of semaglutide has not yet been approved for weight loss indications, the "miracle drug" effect of the injection is still talked about by the market.
The world's first oral GLP-1 receptor agonist was approved for marketing.
Recently, Danish pharmaceutical giant Novo Nordisk announced that its oral semaglutide tablets (product name: Novoxin) have been approved by the National Medical Products Administration (NMPA) on January 26 for the treatment of type 2 diabetes.
According to public information, semaglutide is a GLP-1 receptor agonist, and its injections were approved by the FDA in December 2017 and June 2021 respectively for type 2 diabetes and weight loss, with product names Ozempic and Wegovy, respectively.
The approved oral version of semaglutide is made with semaglutide and the absorption-enhancer SNAC, which can increase bioavailability by about 100 times.
In March 2023, Novo Nordisk announced an important study that confirmed the significant efficacy of oral semaglutide in patients with type 2 diabetes. Subsequently, they submitted a new dose label application to Europe in October of the same year.
At present, oral semaglutide has been approved for marketing in Europe, Japan and other countries and regions, expanding the scope of indications, and can be used for patients with type 2 diabetes who have never received drugs.
Although the new round of semaglutide oral version failed to be approved for weight loss indications, however, the previous experience of Elon Musk's use still has a long-tail effect in the secondary market. In October 2022, Tesla's CEO publicly mentioned his weight loss experience while using semaglutide, which sparked market attention and heated discussions. According to Musk, with regular fasting and the help of wegovy, he lost 9 kilograms in a month.
The impact of this news is also obvious, on January 29, A-share **concept stocks have **. Jinkai Biotech opened up more than 10%, while Haofan Biology and Changshan Pharmaceutical** also rose by more than 5%. However, this time, the approved indications in China are limited to type 2 diabetes and do not involve weight-loss indications, which led to a short-term setback. By January 30th, ** pharmaceutical concept stocks have fallen at the beginning of the session, Haofan Biotechnology fell by more than 10%, Changshan Pharmaceutical fell by more than 7%, and Hanyu Pharmaceutical, Borui Pharmaceutical, etc. also followed.
From the perspective of the global GLP-1 agonist market share in 2022, semaglutide has become the GLP-1 class drug with the highest market share with a proportion of 39% In recent years, Novo Nordisk's semaglutide products have continued to maintain a strong growth momentum.
According to the latest financial report data, the total sales of Novo Nordisk's semaglutide products in 2022 are as high as 7723.7 billion Danish kroner (about 108.).$8.2 billion), a year-on-year increase of 78%. In the third quarter of 2023 alone, semaglutide sales have exceeded $5 billion. Sales in the first three quarters reached 142$3.2 billion, a year-on-year increase of 86%.
In addition, it is worth mentioning that Cagrisema, another blockbuster weight-loss drug of Novo Nordisk, has entered phase 3 clinical trials. In terms of weight loss, previous studies have shown that Cagrisema injection is 15The 6% weight loss was significantly better than that of semaglutide (5.)1%) and cagrilintide (8.)1%)。
The GLP-1 drug market has set off a trend, and oral semaglutide has driven the growth of the industry.
Industry experts generally believe that with the marketing of oral semaglutide tablets, the GLP-1 drug market will usher in a new round of growth, which is bound to further expand the domestic weight loss market.
According to relevant market data, the scale of China's weight loss market has reached 20 billion yuan. According to a report released by the Toubao Research Institute, China's weight-loss drug market is expected to maintain rapid growth from 2021 to 2025, with a compound annual growth rate of 1599%。According to the report, the market for the application of GLP-1 drugs in obese patients in China will peak at more than 20 billion yuan by 2023, while the compound annual growth rate between 2026 and 2030 will be 124%。
In the face of huge market potential, many pharmaceutical companies have entered the GLP-1 field. According to the market share data of GLP-1 peptide drugs in sample hospitals in 2022, semaglutide injection occupies the largest market share, reaching 38%. According to ** data, the overall sales of GLP-1 will reach 6 billion yuan in 2022. With the expiration of the patent of Novo Nord's laglutide original drug, many domestic companies have increased the layout of related similar drugs.
According to the data of Pharmaceutical Intelligence, 13 domestic companies have invested in the R&D and production of liraglutide-related analogues, including Huadong Pharmaceutical and Fosun Pharma (600196SH), Puli Pharmaceutical (300630SZ), Hanyu Pharmaceutical, etc., in addition, including Yixintang (002727SZ), Health Yuan (600380SH), Jincheng Pharmaceutical (300233SZ), Dezhan Health (000813SZ), Puluo Pharmaceuticals (000739SZ), Livzon Group (000513SZ), Aimeike (300896SZ), China Resources Shuanghe (600062SH) and other listed companies have also disclosed their relevant business information to investors. A series of developments show that the GLP-1 market is becoming more competitive, and companies are seeking a piece of the pie in this area.
Previously, Hanyu Pharmaceutical announced that in its peptide weight loss and hypoglycemic pipeline, including tirpatide, semaglutide and liraglutide, the company is actively deploying, especially in the oral and injectable semaglutide.
As the first company to produce GLP-1 drugs in China, Huadong Medicine said in the record of investor relations activities released on January 11 that up to now, the company's liraglutide injection has entered the sales network of more than 800 large hospitals, and is expected to expand to more than 1,000 hospitals by the end of the first quarter of this year.
In terms of the out-of-hospital market, Huadong Medicine said that the main sales channels for the indication of liraglutide** include online platforms and offline pharmacies, and the company is actively promoting the relevant layout. At present, liraglutide injection has covered 20,000 terminal pharmacies, and plans to reach the target of 30,000 around the Spring Festival.
It is reported that Huadong Medicine's liraglutide injection was approved for diabetes indications in China in March 2023, and then approved for obesity or overweight indications in June of the same year, becoming the first GLP-1 drug approved for marketing in China. In addition, in July 2023, Renhui Biotech's benaglutide injection was also approved for weight loss indications.
Huadong Medicine recently disclosed that the oral small molecule GLP-1 receptor agonist HDM1002 tablets under development by the company have been approved by IND in China and the United States, and are currently undergoing phase Ib clinical trials in China.
In the previous chairman of the board of directors personally tried in one fell swoop in one fell swoop, Borui Pharmaceutical's product BGM0504 injection, its weight loss and type 2 diabetes** indications are currently in phase clinical trials.
Hengrui Pharmaceutical's HRS9531 injection was approved to carry out phase 2 clinical trials for weight loss indications. This new drug is a receptor agonist targeting GIP and GLP-1 independently developed by Hengrui, and it is also a dual-target drug with Eli Lilly's tirpatide.
In terms of raw materials, there are still a few domestic enterprises involved in the production of semaglutide APIs, which are mainly subject to high technical thresholds. According to the Center for Drug Evaluation of the State Food and Drug Administration, a total of 4 domestic companies have obtained the qualification of semaglutide API, including Papeptide Biotech, Jianxiang Biotech, Nuotai Biotech Biotech and Tianji Biotech. In addition, companies such as Puluo Pharmaceutical, Puli Pharmaceutical, Taienkang, Hanyu Pharmaceutical, Sirnaomics and Aurisco are also actively developing and applying for relevant qualifications. In addition, 14 companies, including Hanyu Pharmaceutical and Kailaiying, have been filed in the United States, and have the production capacity of semaglutide API industry chain. However, it is generally believed in the industry that domestic API manufacturers still need to strengthen their technology and qualifications to meet market demand.