Source of this article: Times Business School Author: Chen Che
Source: Times Investment Research
Author: Chen Che
Edited by Sun Yiming
With the expiration of the patent of semaglutide, the "miracle drug for weight loss", the battle on the generic drug track of semaglutide in China is becoming more and more intense, and the increasingly serious problem of drug abuse has also been paid attention to by the regulatory authorities.
Hangzhou Jiuyuan Gene Engineering Co., Ltd. (hereinafter referred to as "Jiuyuan Gene") is one of the many generic drugs that have been developed for semaglutide. On July 23, Jiuyuan Gene submitted the form for the second time and applied for listing on the Hong Kong stock market, and the progress of its generic drugs was also unveiled. According to the prospectus, the generic semaglutide generic drug of Jiuyuan Gene has been in the phase III clinical trial stage and submitted an NDA (new drug marketing) application, but the listing time has not been announced.
It is understood that semaglutide is famous for being crowned by the market as a "miracle drug for weight loss". However, in recent years, due to the chaos of irregular market sales and drug abuse, semaglutide has been questioned continuously. At present, semaglutide is strictly regulated by national policies, and CCTV News's "CCTV Finance" published at the end of June this year in "Some groups of people are not applicable!" This drug should be used under the guidance of a doctor", some doctors have reported that the potential side effects are noted, suggesting that the risks of taking the drug may outweigh the benefits.
The generic drug of Jiuyuan Gene is the same kind of drug as semaglutide, and whether it will face the same strict supervision after marketing has become the focus of attention in the capital market.
The increasingly fierce market competition has also made the market worry about the market prospect of Jiuyuan gene generics. In June this year, the original drug company of semaglutide, Novo Nordisk, has been approved for marketing in China, and many domestic companies have also joined the generic drug track of semaglutide.
On July 29 and August 2, Times Investment Research sent letters and calls to Jiuyuan Gene to inquire about major issues such as the competitor's products having been approved for domestic marketing, semaglutide generic drugs or facing strict national supervision, but the other party did not explain.
The problem of drug abuse is becoming more and more prominent, and semaglutide is becoming more and more regulated
Although it is called a "miracle drug for weight loss", semaglutide is not actually specifically used for weight loss. Semaglutide is a long-acting glucagon-like peptide-1, also known as a GLP-1 analogue, which can help regulate blood sugar levels and reduce appetite, and is generally used to treat diabetes-related conditions. Because of its weight-loss effect, semaglutide is jokingly called the "miracle drug for weight loss" by the market.
However, in domestic hospital channels, the use of semaglutide is strictly regulated.
According to the official account of the National Health Insurance Administration on April 16, 2024, "Is the "Miracle Drug for Weight Loss" Entering the Medical Insurance? Two indications for semaglutide have been included in the medical insurance, but for the purpose of weight loss, the medical insurance does not reimburse. Liraglutide injection, which is the same as semaglutide, is not covered by medical insurance reimbursement even if it has been approved by the mainland drug regulatory department for weight loss.
On the same day, the "2024 Special Rectification Work Plan for Violations of Laws and Regulations in the Medical Insurance Fund" issued by the National Health Insurance Administration clearly pointed out that a number of suspicious clues should be issued for semaglutide, and all localities should investigate and deal with over-prescribing, over-scope drug use, and reselling medical insurance drugs through verification, and the use of medical insurance drug funds should be gradually standardized.
In terms of the risk of use, issues such as semaglutide abuse and adverse reactions have also attracted media attention.
CCTV News's "CCTV Finance" at the end of June this year published an article in "Some groups of people are not applicable! This drug needs to be used under the guidance of a doctor", Zhang Peng, chief physician of the bariatric and metabolic surgery center of Beijing Friendship Hospital, believes that "the drug abuse problem of semaglutide is very common, and if the indication for use is not met, do not use it blindly, the risks brought by its medication far outweigh its benefits." Patients may experience adverse reactions such as gastrointestinal upset, hypoglycemia, and acute pancreatitis."
So, will the generic semaglutide of Jiuyuan Gene also face strict supervision after it is launched? Are there similar adverse effects in its products? In this regard, consumers and the capital market have been paying close attention to the clinical trial results of the generic semaglutide of Jiuyuan Genomics to evaluate its safety and efficacy.
Competition intensifies, claiming profits or lower than expected
In addition to dealing with strict regulation of drug abuse and doubts about side effects, Jiuyuan Gene also has to deal with the pressure brought by peer competition.
According to the prospectus, as of July 23, 2024 (the disclosure date of the prospectus), the generic semaglutide generic drug of Jiuyuan Gene is in the phase III clinical trial stage and has submitted an NDA (new drug marketing) application. As for when Jiyoutai and Jikeqin will be launched on the market, Jiuyuan Gene has not given a clear answer.
However, foreign giants have accelerated their efforts to seize the market before the above-mentioned generic drugs go on the market.
The original company of semaglutide is Novo Nordisk (NVO. US), in June this year, the State Medical Products Administration approved the marketing application of "Novo Earning" developed and produced by Novo Nordisk in China. According to the data, Novowin is used for long-term weight management glucagon-like peptide-1 receptor agonist (GLP-1RA) weekly preparation, and its active ingredient is also semaglutide.
According to a report by "Sino-Singapore Jingwei", on June 28 this year, Novo Nordisk said in an interview that it had officially launched the relevant process of Novo Nordisk supply as planned, and would bring this product to the Chinese market as soon as possible.
After Novo Nordisk's products entered the Chinese market, the market share left for Jiuyuan Gene became a suspense.
At the same time, the competition in the domestic semaglutide generic drug track is also quite fierce. Jiuyuan Gene's prospectus revealed that at present, China has approved 15 GLP-1 receptor agonist products for the treatment of type 2 diabetes, including five domestic products. There are another 240 ongoing clinical trials in China to evaluate the effectiveness of GLP-1 receptor agonists in the treatment of type 2 diabetes, including 45 phase III clinical trials.
Among the domestic competitors of Jiuyuan Gene, there is also Huadong Pharmaceutical (000963. SZ), Huadong Medicine's 2023 annual report revealed that it has signed a "cooperative development contract" with Chongqing Paijin Biotechnology Co., Ltd., and actively carried out the international registration of semaglutide. The phase III clinical study of semaglutide injection for diabetes indication of East China Medicine has completed the enrollment of all subjects in the phase III clinical study, and the primary endpoint data is expected to be obtained in the fourth quarter of 2024.
Or based on the strict supervision of drug abuse and the fierce competition in the industry, in the prospectus, Jiuyuan Gene admitted that "the market opportunity of the company's products under development may be smaller than expected, resulting in lower than expected profits after the commercialization of some products under development." ”
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