"Henan -made" new crown pneumonia is approved, and many listed companies grab the express vehicles

[Dahe Daily · Dahecai Cube] (Reporter Wang Leibin Intern Gao Yan) On July 25, the National Drug Administration had the conditions to approve Henan True Biotechnology Co., Ltd. Azf Fixed Pixel to increase the application for the treatment of new crown virus pneumonia.

This product is the first oral small molecular new coronal virus pneumonia therapy drug independently developed in my country. It will play an important role in fighting against the global new crown pneumonia epidemic and promoting the development of Henan and China's biomedical industry.

On the same day, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as Fosun Pharmaceutical) announced a strategic cooperation with real creatures. The areas of cooperation include new crown virus, AIDS therapy and prevention.

Reporter reporters from the Dahe Daily · Dahecai learned that in addition to Fosun Pharmaceutical, A -share listed companies such as Takura Pharmaceutical, Xinhua Pharmaceutical, China Resources Shuanghe, and Aoxiang Pharmaceutical have established cooperative relationships with real creatures.

Many listed companies grab the express train

According to the State Drug Administration, Azfding is the treatment of oral small molecular virus pneumonia for oral small molecular virus pneumonia in my country. On July 20, 2021, the State Drug Administration has attached conditions to approve this product and other reverse-translitease inhibitors to treat adult HIV-1 infection patients with high virus load. This is an attachment to approve new indications for the treatment of adult patients with COVID-19) for the treatment of ordinary new type of coronary virus pneumonia. Patients should be used strictly under the guidance of the doctor.

The State Drug Administration requires listing permit holders to continue to carry out relevant research work, complete the requirements for qualified conditions within a time limit, and submit subsequent research results in a timely manner.

In the process of real biological research and development, it attracted the olive branches thrown by many companies. Many listed companies rely on the "cooperation news" of real creatures, and the stock price increased sharply.

On July 25, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as Fosun Pharmaceutical) announced a strategic cooperation with real creatures. The areas of cooperation include new crown virus, AIDS therapy and prevention.

Both parties will rely on their respective advantages to cooperate in China (excluding Hong Kong, Macao and Taiwan) and the future of the world other than China (excluding Russia, Ukraine, Brazil, and other South American countries and regions).

Zhao Chaoyang, the chairman of the real creature, said that the current new crown pneumonia's epidemic is still plagued by the world, which seriously restricts economic life. It is hoped that Azf will provide a help in the global war and shoulder the social responsibility of pharmaceutical companies. Ten years of real biological entrepreneurship, the original intention does not change, and always adheres to the actual and pragmatic attitude of scientific research to improve human health. In the future, real creatures will continue to be driven by innovation. Global talents will provide more secure and more efficient treatment options for unsatisfactory clinical needs.

In addition to Fosun Pharmaceuticals, at least there are A -share listed companies such as Takura Pharmaceutical, Xinhua Pharmaceutical, China Resources Shuanghe, and Aoxiang Pharmaceuticals have established cooperative relationships with real creatures.

Tuoxin Pharmaceutical, located in Xinxiang City, is an antiviral raw material drug and pharmaceutical intermediate production enterprise. According to public information, Takuka Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. (hereinafter referred to as Xinxiang Pharmaceutical) has the production license of Azf's fixed raw medicine, and its customers are Henan Real Biotechnology Co., Ltd.

On April 22, Takura Pharmaceutical said on the investor interactive platform that the "Azf Stand -up Production Line" of the subsidiary "Xinxiang Pharmaceutical Co., Ltd." has been completed, and the approval of the relevant authorities has not been obtained. There is uncertain time for production.

On May 7th, the investor interactive platform stated that the new production line has begun to operate and is gradually carrying out production.

Tuoxin Pharmaceutical also stated that the production capacity, output and sales of Azf's existing Azf's raw medicines are small; the company's operating income achieved the proportion of the company's operating income in the first phase of the past year in the last year Below 5%, the income and accounted for relatively low.

Although the order volume is small, Tuoxin Pharmaceutical's stock price has risen like a rocket. Since its listing on October 26 last year, Takura Pharmaceutical's stock price has risen from 19.11 yuan/share to the current 132.7 yuan /Stock, the stock price rose nearly 7 times.

Review of real biological research and development process

Since 2020, the news that Azf's news that can be used for the treatment of new crown pneumonia and the treatment of new crown pneumonia oral medicine has been watched by all sectors of society. Some listed companies have greatly risen with the help of this concept of this concept, making a lot of money. So, what kind of enterprise is a real creature?

It is understood that the real creature was established in Pingdingshan City in 2012. It is an innovative drug research and development enterprise integrating independent research and development, production and sales. It is mainly engaged in the research and development of innovative drugs such as antiviral, antitumor, cardiovascular and cerebrovascular, and liver disease. In November 2020, a Series A financing was completed.

In July 2021, the 1.1 type 1.1 innovative drug Azf fixed tablet with independent intellectual property rights with independent intellectual property rights was officially approved to be listed through priority review and approval procedures through the National Drug Administration.

According to its clinical research results, Azf has the advantages of low doses, multi -targets, and long -term orally, and it can be solved by the current drugs such as Lamif who will not produce cross -drug resistance. question. Azf's listing provides new treatment options for AIDS infected people.

In August 2021, the real creature announced the completion of the B -round of 100 million US dollars of financing for product development, clinical project registration, and the commercial development of AIDS 1 new medicine Azfdin, which has been approved for listing. According to the information released by the real creatures at the time, in addition to AIDS 1 new medicine Azf, AIDS is approved for listing, the clinical trials of real creature Azfdin's treatment of new crown pneumonia have been fully promoted in China, Brazil and Russia.

In September 2021, the real creature stated in the official WeChat: "As early as the beginning of the new crown pneumonia epidemic in 2020, Azf would have launched a related exploration of COVID-19. In the preliminary clinical trial, 10 patients 4 4 patients 4 4 patients 4 4 patients 4 The first nucleic acid ride yin rate in heaven reached 90%. "

The reporter from the Dahe Daily Dahecai learned that Azfdin had won the Chinese Patent Gold Award and officially approved for listing last year, achieving a breakthrough in a new type of new drugs in Henan Province. Last October, as one of the scientific and technological achievements, it appeared in the national "Thirteenth Five -Year Plan" scientific and technological innovation achievement exhibition.

In October 2021, Henan's first batch of provincial industrial research institutes and the China -test bases were unveiled. Henan Provincial Institute of Modern Pharmaceutical Industry was officially landed in real creatures. It planned to cultivate it into Henan Modern Pharmaceutical Innovation Practice Base within 3 years.

In April 2022, the People's Government of Pingdingshan City issued the "Notice on Doing a Good House for Industrial Economic Work in 2022". One of the focus of Pingdingshan's industrial economic work in 2022 is to promote the launch of the Hong Kong stock market listing procedures.

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Azf's fixed film industry chain landing Henan

On July 25, the reporter learned from the Henan Provincial Drug Administration that my country's first independent intellectual property oral oral anti -new crown drug Azfdin, from R & D, raw medicine production, preparation production to sales headquarters, etc. Basic conditions, this move marked the iconic breakthrough of Henan Province's implementation of innovation -driven, science and education province, and talent -strong provincial strategy.

The complete formation of a new drug industry chain shall go through many links such as product research and development, clinical trials, production qualification approval, raw materials and accessories association approval, product listing approval, and business sales qualification approval. And all these are based on strict legal licenses, scientific technical verification, rigorous system specifications and mature production technology.

It is understood that the key issues such as the production and operation qualifications of the enterprise production and operation, product registration information, data transfer, and the production of raw materials for large -scale listing of Azf are all resolved. As of now, the relevant registration information data of Azf's fixed -chip has been successfully transferred to our province, and the foundation of enterprises based on Henan's development and growth is stronger. Xinxiang Pharmaceutical Co., Ltd. has obtained production permits for the production line of new raw materials and drugs, and the production of raw materials has been fully guaranteed. Henan True Biotechnology Co., Ltd. has obtained a conditional production license and has a preparation production qualification. At the same time, the Provincial Drug Administration issued a drug business license to real creatures, providing conditions for enterprise construction product sales networks.

The biomedical industry in Henan Province has a good foundation and has strong competitiveness in the fields of biochemical breeding, modern Chinese medicine, new vaccines, and medical consumables. There are more than 300 pharmaceutical companies in the province, and the number of drugs approved each year is about 20, of which most of them are used. The "2021 Drug Review Report" released by the State Drug Administration shows that in 2021, a total of 2,412 applications for clinical trials of new drugs and 389 applications for new drug listing permits, and the review passed 47 innovative drugs. There are very few new categories of structural innovation, and the difficulty and value of innovative drugs to be approved can be imagined.

"Henan is steadily traveling in the corner of the province and the province of traditional Chinese medicine in the province of traditional Chinese medicine." Lei Shengyun, secretary of the party group of the Provincial Pharmaceutical Supervision Bureau, said, "Azf is definitely the first in Henan Province to have autonomous autonomy The 1 -type innovative medicine of intellectual property rights has really opened a good start to boost the high -quality development of the pharmaceutical industry. "

It is understood that the Azf customizer enterprise now has large -scale commercial production capacity, with an annual production capacity of about 6.8 billion pieces, which can meet the treatment needs of nearly 200 million people. "As a new enterprise, we will continue to do the quality management of the entire life cycle of the drug and push the drug to the market at the fastest speed." Henan Real Biotechnology Co., Ltd. CEO and CSO Du Jinfa said.

Responsible editor: Shi Jian | Audit: Li Zhen | Director: Wan Junwei

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