Visual China.
Blue Whale financial reporter Li Minghao.
Recently, Kintor Pharmaceutical announced that the Phase IB III clinical trial of KX-826 and minoxidil in combination with ** Chinese adult male androgenetic alopecia (AGA) has been approved by the National Medical Products Administration to evaluate the efficacy and safety of KX-826 and minoxidil in combination with ** Chinese adult male AGA patients.
On February 2, Kintor Pharmaceutical opened up 14%, and then continued to rise intraday, as of the same day, Kintor Pharmaceutical finally **1HK$82 shares, up 5167%。However, the rise in the share price of Kintor Pharmaceutical has not been sustained, and on February 5, Kintor Pharmaceutical opened low and went low, and the stock price of **17 throughout the day03%, and the stock price closed at 1HK$51 share.
It is worth mentioning that shortly before the approval of the clinical trial of KX-826 and minoxidil, the phase III clinical trial of KX-826 single agent of Kintor Pharmaceuticals had just failed, and the stock price of Kintor Pharmaceutical was also significantly reduced. Although the approval of the phase III clinical trial of Kintor Pharmaceutical's combination drug has played a role in stimulating the stock price to a certain extent, compared with the previous 3Judging from the stock price of HK$39 shares, it is still in "halving"**
KX-826, as the core drug of Kintor Pharmaceutical, is not only one of the fastest-advancing drug candidates, but also the first drug candidate to achieve commercialization. Therefore, after the clinical failure of the single drug, Kintor Pharmaceutical also accelerated the clinical trial of the combination drug. However, there is still a long time from phase III clinical trials to formal commercialization, and the increasingly tight cash flow has become an important problem that Kintor has to face.
Phase III clinical "curse".
KX-826 is a topical androgen receptor (AR) antagonist planned to be developed for the treatment of androgenetic alopecia and acne. In terms of alopecia, KX-826 acts directly on targeted areas of the scalp to locally block androgen-mediated signaling, rather than systematically lowering androgen levels, and its metabolites significantly reduce AR agonist activity in vivo, thus limiting it
According to Frost & Sullivan's analysis, the size of China's hair loss market is expected to reach 41.2 billion yuan in 2026, with an average annual compound growth rate of nearly 12%. In the field of androgenetic alopecia, no new drug has been launched in the world for more than 20 years, and KX-826, as one of the important pipelines of the development industry, has also been pinned on high hopes.
On May 11, 2023, Kintor announced that the Phase II clinical trial of KX-826 in the U.S. for the treatment of male androgenetic alopecia has been successfully completed, with statistically and clinically significant results and a favorable safety profile. The company has begun to prepare for a communication meeting with the U.S. FDA for the end of the Phase II clinical trial, and plans to conduct a global Phase III clinical trial in the United States.
KX-826, which was originally the closest to commercialization, never thought that there would be a gap in the phase III clinical trial in China.
On November 27, 2023, Kintor Pharmaceutical announced that the China Phase III clinical trial of KX-826 for topical** male androgenetic alopecia has read out top-line data. **After 24 weeks, KX-826 was not statistically significant compared to the placebo group.
This has also been interpreted by the industry as a failure in the phase III clinical trial of Kintor Pharmaceutical's KX-826 topical** male androgenetic alopecia. The results of the clinical trial of KX-826 also quickly spread to the secondary market, and on the same day, the stock price of Kintor Pharmaceutical fell by 3186%。
It is worth mentioning that Kintor seems to have fallen into the "curse" of phase III clinical trials, and in recent years, Kintor has been the third major pipeline in phase III clinical trials.
In 2020, Kintor Pharmaceutical's drug under development, Proxalutamide, was found to have the potential of the new crown, and it quickly became the world's leading new crown drug pipeline, and the stock price of Kintor Pharmaceutical also increased from 7HK$2 shares climbed all the way to HK$89 shares, staging a miracle of skyrocketing 11 times.
On December 27, 2021, Kintor Pharmaceutical Co., Ltd. issued an announcement stating that the results of the phase III clinical interim analysis of proxalutamide for non-hospitalized patients with new crown did not reach statistical significance. The day after the announcement, the share price of Kintor Pharmaceutical Co., Ltd. followed, and the stock price fell by 7035%。
On March 28, 2023, Kintor announced the results of the Phase III study of Proxalutamide** metastatic castration-resistant prostate cancer (MCRPC), a next-generation androgen receptor (AR) antagonist, with no significant difference in overall survival (OS) in the primary endpoint.
Cash flow is getting tighter.
At present, Kintor Pharma has 6 drugs in the clinical stage, namely AR-PROTAC compound (GT20029), proxalutamide (GT0918), HEDGEHOG SMO inhibitor (GT1708F), MTOR kinase inhibitor (GT0486), ALK-1 antibody (GT90001) and PD-L1 TGF-dual-target antibody (GT90008).
In the 12 years from 2011 to 2023, Kintor Pharmaceutical has received up to 4.2 billion yuan in financing. However, since the establishment of Kintor Pharmaceutical, there is still no drug under development that has been commercialized and has not yet recorded a profit.
According to the financial report, from 2020 to 2022, Kintor Pharmaceutical will lose 50.8 billion yuan, 84.2 billion yuan, 95.4 billion yuan, a total loss of 23 in three years0.4 billion yuan. The reason for such a high loss is not unrelated to its high R&D expenses. From 2020 to 2022, the R&D expenses of Kintor Pharmaceutical were 32.8 billion, 76.7 billion, 83.9 billion yuan, a total of 193.4 billion yuan. Among them, the expenditure on clinical research was 10.4 billion, 44.8 billion, 4100 million yuan, accounting for 49% of the total R&D expenditure74%。
In addition, the salary of R&D personnel is also the main expense of R&D expenses of Kintor Pharmaceutical. From 2020 to 2022, the salaries of Kintor Pharmaceutical's R&D personnel will be 06.9 billion, 09.7 billion, 15.6 billion yuan, a total of 32.2 billion yuan, accounting for 16 percent of total R&D expenditure6%。
As of the end of June 2023, Kintor Pharmaceuticals suffered a loss of 21.2 billion yuan, compared to 5 in the first half of 2022The loss of 1.8 billion yuan narrowed. This was mainly due to the decrease in expenses of the new crown drug proxalutamide, and the decrease in R&D expenditure and administrative expenditure.
Years of losses and high R&D expenses have made Kintor Pharmaceutical's funds more and more tight. As of June 30, 2023, there is only 69.1 billion yuan, according to the expenses of previous years, Kintor Pharmaceutical's cash is no longer enough to support its R&D expenses for one year.
Kintor Pharmaceutical's KX-826 and minoxidil combination** is also regarded by the industry as one of its "game-breaking" means, and for Kintor Pharmaceutical, the delay in commercialization of core products will inevitably affect the confidence of the entire pipeline under development.
Tong Youzhi, chairman of Kintor Pharmaceutical, also expressed his expectations for this combination of drugs, and said that the combination of clinical phase III drugs has done two large-scale corresponding experiments on animals are very good, and the efficacy of the two single drugs is very close, similar to the clinical data of the human body, but the animal efficacy after the combination has a very good superimposed effect, and I hope that it will be verified in human clinical trials in the future.