(Original title: Clinical trials of innovative oral anti-COVID-19 drugs have been approved, and good news of innovative drug research and development by Zhongsheng Pharmaceutical has been reported frequently)
On the evening of May 15, Zhongsheng Pharmaceutical (002317) issued an announcement that Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd. (hereinafter referred to as “Zhongsheng Ruichuang”), a subsidiary of the company, has taken oral anti-new coronavirus 3CL protease inhibitor RAY1216 tablets in clinical trials. The trial was approved by the State Drug Administration, and received the “Approval Notice for Drug Clinical Trials”, agreeing to conduct clinical trials of RAY1216 tablets.
It is worth mentioning that the previous announcement of Zhongsheng Pharmaceutical showed that the clinical trial registration application for RAY1216 tablets was accepted by the State Drug Administration on May 11, which also means that the clinical trial registration application for this innovative drug is within a short period of time. The approval process is completed within days.
Similar drugs have been approved overseas
According to the announcement of Zhongsheng Pharmaceutical, RAY1216 is a potent and broad-spectrum anti-new coronavirus 3CL protease inhibitor developed by Zhongsheng Ruichuang with global independent intellectual property rights. The cleavage of the viral precursor protein, thereby blocking the replication of the virus, achieves the effect of resisting the new coronavirus.
The 3CL protease cleavage site is in the “highly conserved” region of the coronavirus, and it retains a high degree of activity against the mutant strain of the coronavirus, and the probability of drug resistance is low. The data show that Paxlovid, developed by Pfizer, reduces hospitalization or mortality by 89% and 70%, respectively, whether in high-risk or low-risk groups, and has been approved by the U.S. and Chinese drug regulatory authorities for emergency authorization (EUA) or appendix. Conditionally approved for marketing, it is also the first small-molecule oral anti-new coronavirus drug included in the “New Coronavirus Pneumonia Diagnosis and Treatment Program (Trial Version 9)”.
Zhongsheng Pharmaceutical’s preclinical research shows that RAY1216 is a broad-spectrum and potent anti-COVID-19 clinical candidate compound. Omicron) have potent in vitro inhibitory activity, and the inhibitory effect is comparable to nelmatevir (PF-07321332), which has been approved by the US and my country’s drug regulatory authorities for emergency authorization (EUA) or conditionally approved for marketing.
In the K18-hACE2 mouse model infected with the new coronavirus Delta strain, RAY1216 can effectively protect mice, can significantly reduce the virus titer in lung tissue, improve lung lesions, and has a significant improvement on tissue damage caused by the new coronavirus. A good dose-response relationship was found, and its anti-coronavirus effect was comparable to that of PF-07321332 at the same dose. The safety results suggest that RAY1216 has a low risk of off-target side effects, and the results of studies on teratogenicity and mutagenesis are negative. It has a high therapeutic index and good safety.
Relevant subsidiary or spin-off listing
For Zhongsheng Ruichuang, which is engaged in the research and development of innovative drug RAY1216, the data shows that the company was established in 2018 and is an innovative drug research and development platform under Zhongsheng Pharmaceutical. In December 2020, Zhongsheng Ruichuang launched the B round of financing, and introduced many well-known investment institutions such as Yijing Capital, Huatai Zijin, Yifeng Capital, Bank of Communications International and CITIC Medical Fund to jointly invest, and the shareholding ratio of Zhongsheng Pharmaceutical was diluted to 62.51%, still the controlling shareholder.
According to the 2021 annual report of Zhongsheng Pharmaceutical, Zhongsheng Ruichuang achieved a revenue of 1,003,300 yuan and a net profit of 25,127,800 yuan.
Due to its involvement in the research and development of innovative anti-new crown drugs, the market attention of Zhongsheng Pharmaceutical has continued to increase in the past six months, and the company’s stock price has doubled since November 2021.
At the online performance briefing held on May 10 this year, the communication scene of Zhongsheng Pharmaceutical was very hot, and the company’s executives answered questions from a total of hundreds of investors.
Among them, some investors asked whether Zhongsheng Ruichuang would go public in the future, and Zhongsheng Pharmaceutical replied that Zhongsheng Ruichuang would further enhance its financing capabilities, broaden the financing channels of the capital market, and spin-off listing is also one of the company’s options. Zhongsheng Ruichuang has completed the B round of financing. At the appropriate time, Zhongsheng Ruichuang will comprehensively consider the listing issue according to the market environment at that time, the domestic and overseas securities trading market system and other factors.
Regarding the research and development progress of the company’s innovative drugs, Zhongsheng Pharmaceutical stated that as of now, the company has 6 first-class innovative drug projects and 2 improved new drug projects in different stages of clinical research. Among them, the company has deployed five innovative drugs for the treatment of non-alcoholic steatohepatitis (NASH) in the metabolic disease R&D pipeline, namely ZSP1601, ZSP0678, RCYM001, RAY001 and RAY002.
In the respiratory system R&D pipeline, ZSP1273, a class of innovative drugs used by Zhongsheng Ruichuang for the prevention and treatment of influenza A and human avian influenza, is the only potential best-inclass drug with the same target in the world that is undergoing phase III clinical research, which is expected to solve the problem. Major public health events provide new treatment options and are currently in Phase III clinical studies. In addition, ZSP1273 tablets have received the Drug Clinical Trial Approval Letter (Study May Proceed Letter) issued by the U.S. Food and Drug Administration, agreeing to conduct clinical trials of ZSP1273 tablets in the United States.
It is worth mentioning that on the evening of May 15, Zhongsheng Pharmaceutical also announced the development progress of ZSP1273 tablets. Phase III clinical trials of ZSP1273 tablets have been launched in 79 clinical research centers across the country. A total of 100 subjects have been enrolled, marking a further substantial progress in the clinical research of ZSP1273 tablets.