The clinical end or adjustment of the new crown drug, but the market prospect is not optimistic

According to many domestic media reports, on the evening of August 1, the National Drug Administration's Pharmaceutical Examination Center released the "Questions and Answers on the New Coronatte New Popular Pop infection with New Anti -Virus New drugs infected with new antiviral drugs." "), Guide the research and development and evaluation of new antiviral drugs infected with new pop viruses infected with new coronary virus, and the documents have made adjustments to the clinical endpoints of new coronary drugs.

Once the relevant documents are implemented, how will it affect the development of new crown drugs? A few days ago, after the first domestic new crown drugs were listed, related concept stocks collectively did not rise and fall. Does it reflect the market's concerns about the prospects of this drug?

It is recommended to adjust the clinical end

How to set the efficacy of clinical trials? The document states that for the verification clinical trials of new crown pneumonia drugs for light/ordinary subjects, domestic and foreign guidelines are mainly recommended to clinical results as the main efficacy end point. However, with the emergence of the Omicron mutant, its pathogenicity has weakened, the proportion of severe/critical illness or death is low, and the improvement of clinical return is difficult to observe. Therefore, it is recommended to choose the improvement of clinical efficacy indicators (the time from evaluation to continuous clinical recovery within the appropriate time) as the main efficacy end point, and the virus medicine indicators are the key end points of the key effect.

Wang Wenhua, a partner of CIC Burning Consultation, pointed out that compared with indicators to reduce severe rate/mortality, the technical difficulty to shorten clinical recovery time will be relatively low, and it is also adapted to the current status of the popularity of Omiko poison strains in China. Due to the timely treatment and the relatively complete medical facilities, Omikon Rongzhu's severe rate/mortality rate is extremely low. Therefore, it is difficult to clearly observe improvement in the main reference indicators in clinical clinics. It has also increased the difficulty of drug development.

"The CDE file is recommended to use clinical recovery time such as clinical recovery time, which has more practical clinical endpoints may accelerate the clinical progress of the new clinical drugs at the current clinical stage. In the past 1-2 years, it may usher in the listing of many new crown drugs. "Wang Wenhua said.

The first domestic new crown oral medication was listed, and the market fell collectively?

On July 25, the first domestic new crown oral medication -real creature Azf's fixed form is approved to be listed, but Oxiang Pharmaceutical, which has a commissioned production agreement with real creatures, suffered a limit on July 26. On July 29, Ao Xiang Pharmaceutical has fallen on the 4th, and is currently under sideways.

Except for Aoxiang Pharmaceutical, other related concept stocks have not risen. Relevant partners of real creatures such as Fosun Pharmaceutical, China Resources Shuanghe, and Xinhua Pharmaceutical have fallen to varying degrees.

In fact, from a global perspective, the medicines that have been listed have brought good returns to their respective companies.

Phaxlovid, a new crown oral drug of Pfizer in the first half of the year, was US $ 9.585 billion, of which it contributed $ 8.1 billion in global sales in the second quarter. Emergency use or approval of other markets. Pfizer is currently undergoing clinical research on Paxlovid for immune -damaged people. Molnupiravir (Mnupevir) achieved $ 4.4 billion in sales in the first half of this year. In 2021, Molnupiravir contributed $ 952 million in revenue to Merhado.

The market size of Xin Guankou medication was once considered to reach 100 billion.

Relevant concept stocks have a collective decline in collective concepts, reflecting the market's concerns about the prospects of the new crown oral medication in China? In this regard, Wang Wenhua said that there are several possibilities for the recent decline in the stock price of the new crown concept. First, the domestic epidemic has continued to improve recently. Market investors estimate that the number of applications for new crown oral medications may have declined to a certain extent. Therefore, the stock price may have fallen in the short term. Changes in epidemic prevention policies.

The second is the reason for the stock itself. There are hot air ventilation rotation in the secondary market. The new crown -related concept stocks have performed strongly in the past. Recently, the stock price decline has also been adjusted to release risks. There are also factors in the operating conditions of each company.

However, Wang Wenhua also said that the long -term "dynamic clearing" policy in China has maintained a strict attitude towards the new crown epidemic. The scope of new crown drugs in China must have certain limitations, and it is difficult to truly achieve sales results like Paxlovid.

"In the case of assuming that in the future, in the case of continuing strict epidemic prevention policies and the new crown epidemic, the main market expansion direction of domestic new crown drugs may still be overseas. At that time The design of clinical trials and end point indicators from practical perspectives also requires more clinical data to support the efficacy. "Wang Wenhua said.

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