Recently, Jiuyuan Gene submitted an IPO application to the Hong Kong Stock Exchange for the first time.
It is reported that Jiuyuan Gene has more than 30 years of experience in biomedical R&D and production, and is highly related to East China Medicine, a large domestic listed pharmaceutical company.
Compared with these, what is more attractive is that Jiuyuan Gene was once the domestic pioneer of the world's most popular pharmaceutical industry. In 2023, the "best miracle drug" led by Musk and a number of Internet celebrities will reach a new high, and the performance in this direction exceeding expectations has made Novo Nordisk "No. 1 in Europe" in one fell swoop, and "Challenger" Eli Lilly continues to break new highs.
Therefore, the attention of the outside world to its IPO is also increasing, and for Jiuyuan Gene, this submission is a comprehensive test of its technology and business model by the market.
The growth wave has once again put pressure on the GLP-1 track
In the past two years, the performance of Jiuyuan Gene has been up and down.
The prospectus shows that in the year, Jiuyuan Gene achieved revenue of 13700 million, 112.5 billion; Net profit 11.9 billion yuan, 0600 million yuan, both down year-on-year. The main reason is that its Geo products have been selected for national centralized procurement in successive years.
According to the data, the revenue contribution of Geo stop products has increased from 21 to 188% down to 1. in Q3 '224%。
In Q3 of 2023, its revenue and operating conditions have been significantly restored, and its revenue will be 102.3 billion, net profit of 111.200 million yuan. This is mainly due to the fact that its bone repair product, bone eugenics, has begun to provoke the beam, and the demand has increased sharply. In Q3 2023, the revenue of this product will account for 54% of the total revenue6%。
However, in the medium and long term, there is still great uncertainty in the operating conditions of Jiuyuan Gene.
On the one hand, its current "fist" product, bone eugenics, is also facing the possibility of centralized procurement.
Data shows that bone injury has now become a common bone disease in China. In November 2023, the detailed rules for the centralized procurement of intraocular lenses and sports medicine consumables issued by the National Medical Consumables Joint Procurement Office pointed out that BMP products containing bone morphogenetic protein can be voluntarily joined. The bone eugenics of Jiuyuan gene accounts for 17With a market share of 2%, it ranks second. Therefore, it is not excluded that the bone eugenics of the nine-source gene will be included in the centralized procurement in the future.
It can also be seen that it is expected that once the product is included in the centralized procurement in the future, it will have a huge impact on its revenue.
On the other hand, in 2023, two drugs, Yijiajia, which is the second largest product of Jiuyuan Gene, and the new product Jifuwei, will also be newly included in the centralized procurement. The revenue of the remaining classes of drugs is still declining.
Based on this, it has become a top priority to launch the next "banner" product again.
In fact, Jiuyuan Gene is returning to the weight-loss drug track.
According to the prospectus, its current drug development spans three major fields: metabolic diseases, orthopedics and oncology. Among them, metabolic R&D accounts for nearly half, including semaglutide JY29-2 series for type 2 diabetes, obesity and overweight, JY 5, an innovative drug for obesity and overweight, and dulaglutide biosimilar JY 05 for type 2 diabetes.
Returning to the track of weight loss drugs can be described as "the right time, the right place, and the right people".
First of all, obesity has become a public health concern.
With the rapid development of social economy and the change of dietary habits, the number of obese people in the world continues to grow, and the health hazards caused by obesity are becoming more and more serious. According to the World Health Organization, the number of obese people worldwide has nearly tripled since 1975. According to other statistics, more than half of Chinese adults are overweight and obese, and it is estimated that there are more than 600 million people in China.
Because obesity is also an important cause of cardiovascular and cerebrovascular diseases, various cancers, type I diabetes, hypertension and other chronic diseases, it has been listed by the World Health Organization as the fifth leading risk factor for death.
As a result, weight-loss drugs have gradually changed from non-essential drugs to essential drugs.
In this regard, Wall Street expects that the global first-class drug market will reach more than $50 billion by 2035, of which Goldman Sachs expects that the market will be worth $100 billion by 2030.
GLP-1R is currently the mainstream R&D target of the world's most approved drugs. Among them, liraglutide, semaglutide and Eli Lilly's newly developed tirpatide have been developed for obesity due to their smaller adverse effects and better weight loss effects**.
Among them, semaglutide is the GLP-1** drug with the highest market share at present, and it is also the main route of Novo Nordisk and Jiuyuan Gene. According to CIC, the market size of such products for diabetes, obesity and overweight in China is expected to grow to 43.9 billion yuan in 2032, with a 10-year CAGR of 330%。
Under the huge demand, Novo Nordisk and Eli Lilly, which have already achieved the first development of products and production capacity, have become a high probability event for their performance to continue to grow.
According to the latest data, Novo Nordisk's revenue in the first three quarters of 2023 increased by 80% due to the increase in demand for semaglutide, of which the revenue scale of Wegovy with semaglutide injection increased by 492% year-on-year, thus successfully becoming one of the top ten biopharmaceutical companies in the world in terms of revenue. For the full year 2023, sales growth of 32% to 38% and operating profit growth of 40% to 46% are expected.
The huge profits have attracted the close attention of many eyes in the market both on and off the market. After the news that Novo Nor's semaglutide and Eli Lilly's tirzepatide are about to complete their marketing applications in China in 2023, the two companies have once again quickly gained the hot pursuit of global capital.
In the A-share market, the ** pharmaceutical sector led by Changshan Pharmaceutical also led the market at that time. In just 29 trading days, Changshan Pharmaceutical's share price has risen by 27 times.
Secondly, "geographical advantage".**The current huge demand for drugs also highlights the dilemma of insufficient product variety and production capacity. In 2023, due to the shortage of **, Novo Nordisk will stop advertising some of the advertisements for semaglutide injection in the United States in May.
And the domestic market is even more so. According to related ** reports, even if semaglutide for diabetes is out of stock in some hospitals, semaglutide online is hard to find.
At present, the global first-class drug market is mainly dominated by the two giants of Novo Nordisk and Eli Lilly. However, the production capacity of these two small molecule drugs is relatively scarce, and neither of them has been approved for weight loss indications in China. In China, only liraglutide injection launched by Zhongmei Huadong and benaglutide of Renhui Biotech will be approved for marketing as GLP-1** indication drugs in the second half of 2023.
In general,Due to the late approval of domestic regulatory indications for weight loss, the domestic market is still in its infancyThere is still room for domestic biotech companies to catch up.
However, combined with the current R&D progress of domestic biological R&D enterprises, it can also be seen from the side that the door to GLP-1 as a new drug for the first indication is about to open, and the battle in the blue ocean field is also poised to start.
Yu: Anxin**.
In this situation, Jiuyuan Gene, which has a long historical relationship with liraglutide, which is the only one approved for ** indication marketing, has come to the stage, and it is extremely eye-catching.
In fact, Jiuyuan Gene began to develop GLP-1 receptor agonists as early as 2005, and was the first to develop the first IDN-approved liraglutide biosimilar in China.
According to the prospectus, Jiuyuan Gene has a number of biosimilars suitable for diabetes under development. These drugs mainly choose the semaglutide route with the highest market share and relatively mature application. Among them, Jiyoutai for T2DM has entered the advanced stage of clinical development, and may submit NDA to the NMPA in the first half of 2024 at the earliest, which has great potential to become the first semaglutide biosimilar approved for commercialization in China.
More notably, Gillamine, whose indication is obese or overweight, has also obtained IND approval and has entered the phase III clinical trial stage. There is also an oral semaglutide** drug, and a ** innovative drug is under development.
Among them, this innovative ** drug JY 54 has great combination potential. It can be used in combination with one or more GLP-1 analogues and has the potential to further enhance the effect. So far, there is only one amylin analogue symlin on the market in the world. Jiuyuan Gene has one patent application pending and one PCT patent application pending in China for peptide derivatives and the use of JY54. JY 54 is expected to submit an IND application in the fourth quarter of 2024, and according to public clinical data, the clinical effect of the drug will be significant in the future.
On the whole, in China, Jiuyuan Gene is still relatively advanced in technological innovation and R&D progress in the direction of GLP-1 inhibitors, and the product matrix planning is relatively complete.
According to the prospectus, Jiuyuan Gene is planning to expand the production facilities of semaglutide** biosimilar products in the short term, combined with the rapid research and development progress of its semaglutide** drug, which gives investors greater imagination.
Conclusion
Small molecule ** drugs are indeed the "reddest" biomedical track so far in 2023, and their huge market prospects in the future are still relatively clear. However, from the perspective of the industry, the future of "* miracle drug" is still very long.
The huge incremental space of GLP-1** drug itself is brought about by its consumption attributes, but at present, its "Taoism seems to be shallow" and it still needs to be further researched.
At present, the obvious problem is that there is a problem after the discontinuation of GLP-1**.
In December 2023, the authoritative medical journal "Journal of the American Medical Association" released the results of a study showing that continuous use of Eli Lilly's new drug Zepbound (Eli Lilly officially said that this is beyond the existence of Novo Nordisk Semaglutide** drug) can make patients lose weight by 209%, but after stopping the drug, the weight will be **half of the previous weight loss; Patients who continue to inject zepbound for one year can lose an average of 55%。
This means that the current GLP-1 weight loss indication drug still needs to be taken by some patients for a long time or even for life to maintain its efficacy. Even some groups with particularly obvious "heterogeneity" are difficult to achieve a delayed effect even if they continue to use such ** drugs.
In addition, GLP-1** itself is still a prescription drug, and abuse may cause greater health risks.
In July 2023, two GLP-1 drugs of Novo Nordisk were warned by the regulatory authorities that people who do not meet the indications will have thyroid disease and mental health problems if they abuse it severely. Other reports, such as those published in the Journal of the American Medical Association, have repeatedly pointed out that GLP-1** may cause pancreatitis, kidney failure, and stomach problems.
Therefore, the consumption attribute of GLP-1** is still very controversial at present. This is also the main contradiction point for some groups in the market to "sing" Novo Nordisk.
In short, even under the leadership of the two giants, GLP-1 still has many mysteries to unlock if it wants to become a veritable "** miracle drug".
This is especially true for "fledgling" GLP-1 pharmaceutical domestic enterprises.
At present, domestic biotechnology companies focus on the generation of GLP-1 drugs with lower barriers to R&D and production, so as to adapt to diabetes.
In terms of bariatric indications, as mentioned above, except for Huadong Medicine and Renhui Biology, which have obtained approval for marketing authorization applications for overweight and obesity indications, most of the GLP-1 drugs for the first-class drug indications of the rest of the companies are in the R&D or clinical trial stage, and it is difficult to determine what their respective results will be in the future.
This is also why the hype in the domestic market has gradually "cooled" after receiving warning letters from Borui Pharmaceutical and Baihua Pharmaceutical. Even on January 26, Novo Nordisk approved the first oral version of GLP-1 receptor agonist in Chinese mainland to be listed on the market, and such a multi-industry chain event had a significant impact, but did not drive the sentiment of the ** drug sector, but fell.
The key is that there is a lack of authentic GLP-1 pharmaceutical biotechnology companies in China.
All in all, in short, the growth of the ** drug track is quite clear. With the advancement of Novo Nordisk, Eli Lilly China's NDA applications, and Roche, which ranks first in the global pharmaceutical biotechnology industry in terms of revenue, is also returning to the GLP-1** drug arena, and the entire competition situation at home and abroad is also obviously anxious.
At this time, whether from the perspective of competition or product demand, the R&D progress of domestic first-class drug R&D enterprises, including Jiuyuan Gene, is particularly important.
*: Hong Kong Stock Research Society.