The first domestic new crown oral medication was submitted to the domestic listing application, and the data of prevention prevention was still lacking.

15.07.2022

Number of this text: 1963, reading time for about 3 minutes

Guide: If you cannot prove that taking antiviral drugs can prevent severe illnesses and only shorten the virus turning time, then even if the clinical trials are very strict, its importance will be greatly reduced.

Author | First Financial Qian Tongxin Lin Zhiyin

Domestic new crown antiviral small molecules have made new breakthroughs recently. On July 15th, Henan Real Biotechnology Co., Ltd. announced that the results of Azf's Azf's fixed tablet for the treatment of new coronary virus pneumonia were applied to the forecast of phase III clinical trials. Recently, it has officially submitted a listing application to the State Drug Administration.

The real creature has also become the first Chinese pharmaceutical company to submit a new crown small molecule in China in China.

Azf was originally a oral anti-AIDS drug under the real creature. In July 2021, it was approved by adult HIV-1 infection patients for the treatment of high virus loads. Since the emergence of the new crown epidemic, real creatures have also launched clinical research used in the treatment of new crown indications. As early as March of this year, the medicine had completed the third phase of clinical trials for the treatment of new coronary virus pneumonia at home and abroad.

The clinical trial design of multi -center, random, double -blindness, and placebo -controlled clinical trial design in Phase III registered clinical trials that support the application of the drug listing. The clinical trial results show that Azf will have the activity of inhibiting the new coronary virus. The virus clearance time is 5 Around the sky.

In terms of significant improvement of clinical symptoms, Azf's fixed tablet can significantly shorten the time improvement of moderate new crown symptoms. Among the seventh day of the seventh clinical symptoms after the first administration, the proportion of Azf's final group was 40.43%, and the proportion of placebo groups was 10.87%. There are significant statistical differences between the husband and placebo group.

However, this drug is still unknown to the effective data of the new coronary. As of the close of July 15, Azfding's processing manufacturers and dealers' stock prices plummeted. Both Aoxiang Pharmaceutical and China Resources Shuanghe fell, and Xinhua Pharmaceutical's stock price fell more than 5%.

According to reports, Azf is definitely a nucleoside analog of a broad -spectrum inhibitory RNA -dependent RNA polymerase (RDRP), which can also be specifically acting on the new coronary virus RDRP, thereby inhibiting virus replication, drug -targeted drug targeted Strong.

"Like Redsovir, Azf was originally listed as anti -AIDS drugs, and it was consistent in terms of mechanism." Ma Dawei, an academician of the Chinese Academy of Sciences, said to the First Financial reporter, " Small molecular drug VV116 is also improved on the basis of Redsie. "

But at present, whether it is Azfding or VV116, it is only for patients with early to moderate symptoms, and the more important indicator of evaluation of small molecular drugs is the prevention effect on severe illness. A drug expert told the First Financial reporter: "From the current situation, if you cannot prove that taking antiviral drugs can prevent severe illnesses, only the virus can only be shortened. It will greatly reduce. "

Some people engaged in the development of new crown oral medication told the First Financial Reporter that the real creature Azf's new crown indication phase III clinical trial designed 1 main end and 17 secondary end points. This time the company disclosed only The three endpoint research situations are still difficult to comprehensively judge the specific effects of this drug.

After the real creature submitted the application for the listing of the new crown indication of the Azf, whether it can be approved by the drug supervision bureau, there are still certain uncertainty.

After the real biological clinical data and the news of the submission of listing applications were announced, the stock price of another domestic new crown small molecule was closed on the same day.

On May 23 this year, Junshi Biological Announcement stated that anticucleoside anti -new crown drug VV116 tablets were used to compare the Narmatvir tablets/Litonovid Phase III registered clinical research reaches the main end of the plan, and stated that it will be submitted to the recent listing application.

As of now, no public information has shown that Junshi Bio has submitted a listing application to the regulatory authorities. First Financial reporter learned that real creatures may be faster than Junshi creatures.

At present, the only clinical data about VV116 is only a research from the team of Professor Zhang Wenhong from Huashan Hospital for 136 patients. It shows that early taking the drug can shorten the virus time for 2-3 days.

Zhang Wenhong said on May 22 at an academic conference of respiratory disease prevention and control: "China began to introduce early antiviral treatment in the recent round of epidemic, but the efficacy of antiviral drugs needs to be improved."

At present, there is only one new crown small molecule oral medicine in China, which is approved for listing, which is Paxlovid of Pfizer, which is an imported drug. In addition to Pfizer, there are other multinational pharmaceutical companies that are also "aiming" the Chinese market. Recently, two multinational pharmaceutical companies have reportedly reported to launch new crowned small molecules in China. Yiyi and Merck in the United States.

On July 4 this year, Ping An Yanye Yiyi Co., Ltd. announced through the official website that the company took the new type of coronary virus pneumonia (COVID-19) in developed an oral antiviral drug S-217622 to the China National Drug Administration's Drug Review Center ( CDE) began to submit relevant preparation materials for the application for new drug listing permits. Ping An Yanyani said that before the formal submission of a new drug listing license application, the company had submitted an application for the communication conference to the CDE to promote the future application process of the drug. Ping An Yanye Yiyi is a company established by Japanese pharmaceutical companies, Yan Yei and China Ping An. At the same time, in June of this year, Tian Anna, president of Merck China, also said that the company has always maintained positive communication with the regulatory authorities about the new crown oral medication. Submitting, waiting for further feedback, hoping to bring this drug as soon as possible to the urgent Chinese patients. Similarly, these two imported new crown small molecules can go through the Chinese market smoothly, and there are certain uncertainty.

Observed people in the pharmaceutical industry believe that in the face of so many new crown small molecules orally to prepare for the listing, the subsequent price "kills" or inevitable.

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