Zhongsheng Pharmaceutical (002317): The first case of ZSP1273II intervention involved in the development of new influenza drugs has been successfully promoted
Event: The company recently announced that the clinical trial of ZSP1273, an innovative drug for the prevention and treatment of influenza A and human avian influenza, organized by the holding subsidiary Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd. has been conducted in 25 clinical studies across the country.The center is conducting a phase II clinical trial, and the first case has been enrolled.
ZSP1273 Phase II clinical trials have smoothly advanced the research and development progress in China, and Academician Zhong Nanshan served as PI.
ZSP1273 is a small-molecule RNA polymerase inhibitor intended for the treatment of influenza A and human avian influenza. It is the first domestic small-molecule RNA polymerase inhibitor to enter clinical stage II for the treatment of influenza A.
Preclinical tests have confirmed that the drug’s anti-influenza virus activity in vitro is about 1,000 times that of the neuraminidase inhibitor oseltamivir, and about 10 times that of the same target drug VX-787.
ZSP1273 has been proven to be safe and stable in pharmacokinetics in Phase I clinical trials. Academician Zhong Nanshan is the head of the project and research work for Phase II / III clinical trials.
The first phase II lawsuit was enrolled and is expected to end in the first half of 2020.
At present, the first patient of the ZSP1273 phase II clinical trial has been enrolled. It is expected that 400-50杭州桑拿0 cases will be completed by the first half of 2020. May 2020?
Data from Phase II clinical trials were obtained in June.
If the phase II clinical trial results are positive, the drug is expected to undergo phase III clinical trials in September 2020 and obtain phase III clinical trial data in the first half of 2021.
If the phase II and III clinical trials progress smoothly, the drug is expected to be declared for marketing in 2021.
Influenza has a high global incidence, and new drugs are generally susceptible to the entire population that is clinically needed, and the global incidence is high.
Influenza is an acute respiratory infectious disease caused by influenza viruses. Influenza A and B viruses are presented annually, and influenza A viruses can cause a global pandemic.
According to data from the World 都市夜网 Health Organization, about 5% -10% of adults and 20% -30% of children worldwide develop the flu each year, and about 3-5 million people develop severe influenza every year, which leads to about 290-650,000 cases.Respiratory disease-related deaths.
Antiviral drugs are an important line of defense, and oseltamivir is a first-line medication.
Influenza vaccination is an important means to prevent influenza, but due to the highly variability of influenza viruses, the role of vaccines is often escaped by influenza viruses, so drug therapy is an important line of defense for influenza viruses.
There are currently three types of anti-influenza virus drugs on the market, namely neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers.
Neuraminidase inhibitor oseltamivir is the mainstream mainstream anti-influenza virus drug; the alternative method of paramivir is intravenous infusion, which is mainly used for severe or inability to take oral; zanamivir is taken by absorption, the market shareExtremely low.
Hemagglutinin inhibitor Abidol and M2 ion channel blocker amantadine, amantadine have not been awarded the “Influenza Diagnosis and Treatment Program (2019)” due to limited clinical data and elimination of current epidemic strains》 Mainstream recommendation.
Significance or trend, preliminary clinical demand for antiviral drugs.
The M2 ion channel blocker amantadine was marketed in 1966, and its derivative amantadine was marketed in 1987. At present, almost all popular influenza A virus strains have replaced such antiviral drugs.
The neuraminidase inhibitor oseltamivir was approved by the FDA in 1999 and has been on the market for over 20 years.
Oseltamivir was listed in China in 2001. In recent years, it has been rapidly increasing in volume, and there has also been a certain degree of recognition problems.
In this context, new anti-influenza virus drugs are clinically needed.
The market size of ZSP1273 is expected to reach 22.
There is a huge need for clinical treatment of 92 million anti-influenza virus drugs.
It can be seen that its spread is rapid, the entire population is generally susceptible, and it can cause substitution epidemics every year.
The annual incidence of adults is about 5% -10%, and the incidence of children is about 20% -30%.
In addition, the number of people at high risk of severe cases of hypertension and influenza is huge.
People suffering from chronic underlying diseases such as chronic respiratory diseases, cardiovascular system diseases, metabolic and endocrine system diseases are more likely to develop severe cases after being infected with influenza virus.
Sentinel surveillance data for inpatient SARI cases in China from 2011 to 2013 showed that 37% of patients with severe influenza had chronic underlying disease, of which cardiovascular disease (21.
5%), chronic two-year pulmonary disease (COPD) (7.
7%) and diabetes (7.
4%) is the most popular.
This type of severely high-risk group is necessary for antiviral treatment after being infected with influenza virus. It can also be administered in advance after exposure.
Based on the high incidence of the entire population and the large base of severely at-risk populations, the clinical use of recombinant anti-influenza virus drugs is in great demand.
At present, anti-influenza virus first-line treatment drugs can be used quickly and can achieve this type in 2017 and 2018 respectively.
10,000 yuan, 22.
470,000 yuan, 29 in the first half of 2019.
300,000 yuan, an annual increase of 116.
The market size of ZSP1273 is expected to reach 22.
9.2 billion yuan.
In the context of the current degree of toxicity of oseltamivir and the demand for new clinical anti-flu drugs, if the company’s new drug ZSP1273 is successfully marketed, it will gradually share the huge market of anti-flu virus drugs.
At the same time, the spread of knowledge on correcting the flu, the understanding of the difference between the flu and the common cold, and the overall rate of seeking medical treatment and antiviral treatment among people with flu have continued to increase.
With reference to the penetration rate and treatment costs of oseltamivir, Xofluza and other anti-flu drugs, we made a detailed calculation of the market space of the product.
We expect that if ZSP1273 is successfully listed, its market size is expected to reach about 22.
9.2 billion yuan.
Profit forecast and investment rating: The company’s traditional business has grown steadily, clinical trials of new drugs such as the new influenza drug ZSP1273 and NASH new drug ZSP1601 have been steadily progressing, and research and development results have gradually emerged.
The company is expected to achieve revenue of 26 in 2019, 2020 and 2021.
07 and 31.
30,000 yuan, net profit attributable to mothers is expected to reach 4 respectively.
21 and 5.
7.2 billion, EPS is 0.
64 and 0.
70 yuan, the current expected corresponding estimate is 17.
77 and 14.
36 times, maintaining the “recommended” level.
Risk warning: risk of new drug development; risk of drug price reduction.