The annual output will reach 3 billion pieces!The first domestic new crown oral medicine Azf's fixed film is put into production in Pingdingshan ｜ Extremely engraved

Dahe Cai Cube "Extreme Carrier" No. 770

Dahecai Cube "Extreme Carrier" team reporter Wang Leibin Chen Shiang Duan Weiduo

On August 2nd, the new crown oral medicine Azf's fixed film developed by Henan Real Biotechnology Co., Ltd. (hereinafter referred to as real creatures) was officially put into production in Pingdingshan.

As the first oral small molecular new coronary virus pneumonia therapy drug independently developed by my country, its formal starting production 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.

At the scene of the production ceremony, the real creature founder Chaoyang said in an interview with reporters that the usage of Azf's setting is 7 days a course of treatment, 5mg per day, which can significantly increase the nucleic acid to the new crown pneumonia. The annual output of preparations can reach 3 billion pieces.

on site:

Azf's fixed film is officially put into production in Pingdingshan,

It is the first domestic drug for treatment of new crown pneumonia

"Henan True Biotechnology Co., Ltd. New Guan Oral Yao Azf is put into production." Zhang Leiming, Secretary of the Pingdingshan Municipal Party Committee, announced.

At 10 am on August 2nd, the actual biological new crown oral medicine was held in Pingdingshan City, which marked the official start production of the first oral small molecular new crown virus pneumonia's treatment of the first oral small molecular virus pneumonia.

The Chaoyang said at the production ceremony that Azf's anti -new crown indication was approved to be listed, which is an important milestone for real biological development. The real creature will effectively fulfill the responsibility of the first responsible person of the drug safety, comprehensively strengthen the quality management of Azf's fixed life cycle, ensure that the drug production and operation continues to be legal and compliant, and strive for more innovative results in the future. The development of the pharmaceutical industry has contributed to the power of Henan.

Zhao Wenfeng, mayor of Pingdingshan City, said that the real creature "Azfding" was officially put into production as the first domestic drug to be approved for treatment of new crown pneumonia. It is another fruit of political schools and enterprises and win -win cooperation. The gap in the research and development of drug production marks the opening of a new chapter in the development of the biopharmaceutical industry in Pingdingshan.

The reporter noticed at the scene that after the production -production ceremony, the production line in the real biological solid system workshop began to operate.

feature:

It can significantly increase the nucleic acid to the yin yin in patients with new coronary pneumonia.

With the advantages of convenient administration, conservative targets, good medicinal effects, etc.

In the workshop visit, Chaoyang introduced that the dosage of Azf's scheduled medication was small, the daily dosage was only 5mg, and a course of treatment in 7 days can significantly increase the nucleic acid ride yin rate of patients with new crown pneumonia and good safety.

So, what are the characteristics of Azf?

On the afternoon of August 2nd, a reporter from Dahecai's cubic cube interviewed the inventor of Azf, and Chang Junbiao, deputy secretary and vice president of the Zhengzhou University Party Committee and Vice President, was interviewed. He introduced that Azf must be oral drugs for small molecules, which has the advantages of convenient administration, conservative targets, good efficacy, easy production and storage.

Chang Junbiao said that Azf must be a unique nucleoside small molecular drug design. Its structure is very similar to the nucleotide substrate required during the virus replication process, and the target target is relatively conservative. Essence Clinical trials have proved that it has good therapeutic effects on the new crown virus variable strains, including Alpha, Beta, Delta, and Omikon.

In terms of price, he introduced that Azf is the first anti -new crown oral medication with independent intellectual property rights in my country. Its listing can reduce the cost of new crown pneumonia and ultimately benefit patients.

Discovery:

Accelerate the process of drug listing,

The annual output of future preparations can reach 3 billion tablets

Sun Guoquan, the director of the Pingdingshan Market Supervision Bureau, said in an interview with the reporter from the Dahe News Daily, Dahecai, that in order to speed up the listing process of Azf's determined, Henan Provincial Drug Administration shall implement special affairs on the implementation of the Azf drug production license. The office and special affairs are quickly handled, so that the "Drug Production License" and "Drug Operation License", which were originally scheduled to issue in mid -May to April 25.

"Enterprise Drug GMP compliance inspection information was reported on May 10th. The expert group overcame multiple difficulties. On May 13th, the GMP compliance inspection site inspection was completed, and the task was completed 2 days in advance." Sun Guoquan said.

In May of this year, the real creature Pingdingshan production base has successfully passed the standardized inspection of the quality management of drug production organized by the Provincial Pharmaceutical Supervision Bureau, marking that the company's own production bases can comply with the production and operation of drugs. The total construction area of ​​the base is 32,000 square meters, and the annual output of the future preparation can reach 3 billion pieces.

On July 25 this year, the State Drug Administration had the conditions to approve the application of Azf's fixed tablet to increase the application for the treatment of new coronary virus pneumonia. On July 20 last year, the State Drug Administration had the conditions to approve the class 1 innovative medicine, Azf, was listed on the market. At that time, the medicine was the world's first double -target anti -AIDS innovation medicine.

Visiting:

The material drug producer has all the conditions for mass production,

Investment in equipment automation has been increased

What is the production process of Azfdin and where does the raw medicine come from?

On July 30, a reporter from the Dahe Daily · Dahecai Cube entered Xinxiang, Henan to explore the first Azf's raw material drug producer -Henan Listed Company Takinxin Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinxiangxiang Pharmaceutical "), the Azff produced by the company, as the main effective ingredient of active drugs and preparations, will play a key role in treating new coronary virus pneumonia.

For the newly put into production of the Azf's raw material drug production line, He Bin, deputy general manager of Xinxiang Pharmaceutical, told reporters that compared with other production lines, the production line has increased the investment in equipment automation. Interest and production and operation costs, optimize the production environment and conditions. At the same time, in order to improve product quality stability and reliability, the company has systematically trained and manage the relevant personnel of the production line, and strengthens the entire process control of the production of raw medicine. According to the official website of the National Drug Administration (CDE), Xinxiang Pharmaceutical is a unit associated with the preparation enterprise. It is a real biological qualified supplier, and the first manufacturer of Azf's raw medicine.

It is understood that the Azov's APIP production line of Xinxiang Pharmaceutical Pharmaceutical passed the on -site inspection of the Food and Drug Review and Inspection Center in Henan Province in April this year, and officially obtained the production qualification.

In Azf's dry charter workshop, the reporter from the Dahe News Dahecai Cube saw that the workers were busy using polyethylene, aluminum foil and other packaging Azoff Simplica medicines, every 5 kg of 5 kilograms, and then closed them in a dedicated dedicated after packaging. Storage in the barrel and then enter the finished warehouse.

In the finished product warehouse, the reporter saw that Azf's raw materials that had been produced were neatly placed, waiting for the finished product production factory that transported to Azf's medicine.

The reporter learned that Azf's raw materials need to be stored in a dedicated warehouse below 25 ° C, so that it will not affect the stability of the medicine.

According to He Bin, at present, Takuki Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. Azf Fixed Material Production Line has all the conditions for mass production and can continue to produce, which can meet market demand. In the future, the rhythm of production will be adjusted according to market conditions.

News 1+1: Review of real biological research and development process

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, a type of innovative medicine Azf fixed by real biological research and development and owning independent intellectual property rights was officially approved to be listed through priority review and approval procedures through the National Drug Administration.

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. 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.

Responsible editor: Wang Shidan | Audit: Li Zhen | Director: Wan Junwei

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