Dahe Caifang “Ji Ke” Issue 770
Dahe Fortune Cube “Extreme Moment” team Reporter Wang Leibin Chen Shiang Duan Weiduo
On August 2, the new crown oral drug Azvudine Tablets developed by Henan Real Biotechnology Co., Ltd. (hereinafter referred to as Real Bio) was officially put into production in Pingdingshan .
As the first oral small-molecule novel coronavirus pneumonia treatment drug independently developed by my country, its official start of production will play an important role in combating the global novel coronavirus pneumonia epidemic and promoting the development of the biopharmaceutical industry in Henan and China.
At the commissioning ceremony, Wang Chaoyang, founder of Real Biology, said in an interview with reporters that the dosage of Azvudine tablets is a 7-day course of treatment, 5 mg per day, which can significantly improve the nucleic acid conversion of patients with new coronary pneumonia. The production rate is good, and the safety is good, and the annual output of the preparation will reach 3 billion tablets in the future.
< span>Azvudine tablet was officially put into production in Pingdingshan,
the first drug approved in China to treat COVID-19
“Henan True Biotechnology Co., Ltd. has put into production the new crown oral drug Azvudine Tablets.” Zhang Leiming, Secretary of the Pingdingshan Municipal Party Committee, announced.
At 10:00 am on August 2, the production ceremony of the real biological new crown oral drug Azvudine tablet was held in Pingdingshan City , which marks the official start of production of the first oral small-molecule novel coronavirus pneumonia treatment drug independently developed by my country.
Wang Chaoyang said at the commissioning ceremony that the approval of Azvudine for anti-new crown indications is an important milestone in the development of real biology. Real Bio will earnestly fulfill the responsibility of the first responsible person for drug safety, comprehensively strengthen the quality management of Azvudine tablets throughout the life cycle, ensure the continued legal compliance of drug production and operation, and strive to produce more innovations in the future, so as to serve the nation’s The development of the pharmaceutical industry contributes to the strength of Henan.
Zhao Wenfeng, Mayor of Pingdingshan City, said that the real biological “Azvudine”, as the first drug approved for the treatment of new coronary pneumonia in China, was officially put into production. The fruitful results have filled the gap in the production and development of original research drugs in the province, marking the beginning of a new chapter in the development of Pingdingshan’s biopharmaceutical industry.
The reporter noticed at the scene that after the commissioning ceremony, the production line in the real biological solid preparation workshop started to run.
< span>It can significantly improve the negative rate of nucleic acid in patients with new coronary pneumonia.
It has the advantages of convenient administration, conservative target and good efficacy, etc. Advantages
During the workshop visit, Wang Chaoyang introduced that the dosage of azvudine is small, only 5mg per day, and a 7-day course of treatment can significantly improve the rate of new coronary pneumonia The patient’s nucleic acid conversion rate is negative, and the safety is good.
So, what are the characteristics of Azvudine?
On the afternoon of August 2, a reporter from Dahe Finance Cube had an exclusive interview with Chang Junbiao, the inventor of Azevudine, Deputy Secretary of the Party Committee and Vice President of Zhengzhou University. He introduced that azvudine is a small molecule oral drug, which has the advantages of convenient administration, conservative target, good efficacy, and easy production and storage.
Chang Junbiao said that Azvudine is a unique nucleoside small molecule drug design, its structure is very similar to the nucleotide substrate required for virus replication, and its target is relatively conservative. So it is still effective against virus variants. Clinical trials have proven that it has a good therapeutic effect on new coronavirus variants including Alpha, Beta, Delta, and Omicron.
In terms of price, he introduced that azvudine, as my country’s first oral anti-COVID-19 drug with independent intellectual property rights, can reduce the cost of COVID-19 treatment and ultimately benefit patients.
< span>Accelerate the drug listing process,
The annual output of preparations in the future will reach 3 billion tablets p>
Sun Guoquan, director of the Pingdingshan Municipal Market Supervision Bureau, said in an interview with a reporter from Dahe Daily and Dahe Finance Cube that in order to speed up the listing process of azvudine, the Henan Provincial Drug Administration has issued a production license for Azvudine. The implementation of special handling and quick handling of special matters has brought the “Drug Production License” and “Drug Distribution License” originally scheduled to be issued in mid-May to April 25.
“Enterprise drug GMP compliance inspection data on May 1The report was completed on the 0th, and the expert group overcame multiple difficulties. On May 13th, the on-site inspection of the enterprise GMP compliance inspection was completed, and the task was completed 2 days ahead of schedule. “Sun Guoquan said.
In May this year, the real biological Pingdingshan production base has successfully passed the compliance inspection of the drug production quality management standard organized by the Provincial Food and Drug Administration, indicating that the company’s own production base can be compliant. The production and operation of pharmaceuticals. The base has a total construction area of 32,000 square meters, and the annual output of preparations in the future will reach 3 billion tablets.
On July 25 this year, the State Food and Drug Administration approved Azvudine tablets with conditions. Increase the registration application for the treatment of new coronavirus pneumonia. On July 20 last year, the State Food and Drug Administration approved the listing of a class 1 innovative drug, Azvudine Tablets, which was the world’s first dual-target anti-AIDS innovative drug at that time.< /p>
API manufacturers have all the conditions for mass production,
Increased investment in equipment automation
What is the production process of Azvudine, and where does its API come from?
On July 30, a reporter from Dahe Daily and Dahe Caifang walked into Xinxiang, Henan, and realized Exploring the first Azvudine API manufacturer, Xinxiang Pharmaceutical Co., Ltd. (hereinafter referred to as “Xinxiang Pharmaceutical”), a subsidiary of Henan-listed company Tuoxin Pharmaceuticals The main active ingredients of pharmaceutical ingredients and preparations will play a key role in the treatment of COVID-19.
for new production The azvudine API production line, He Bin, deputy general manager of Xinxiang Pharmaceutical, told reporters that compared with other production lines, this production line has increased investment in equipment automation, the main purpose is to improve production efficiency, reduce labor intensity and production. operating costs, optimizing the production environment and conditions. In order to improve the stability and reliability of product quality, the company has systematically trained and managed the relevant personnel of the production line, and strengthened the control of the whole process of API production.
The official website of the Center for Drug Evaluation (CDE) of the State Drug Administration shows that Xinxiang Pharmaceutical is a unit that is associated with preparation companies for approval, is a real bio-qualified supplier, and is also the first manufacturer of azvudine APIs. manufacturer.
It is understood that the azvudine API production line of Xinxiang Pharmaceutical passed the on-site inspection of the Henan Provincial Food and Drug Evaluation and Inspection Center in April this year, and officially obtained the production qualification.
In the azvudine lean packaging workshop, a reporter from Dahe Daily and Dahe Caifang saw that workers were busy packing azvudine raw materials with polyethylene and aluminum foil. After packaging, it is sealed into a special storage barrel, and then enters the finished product warehouse.
In the finished product warehouse, the reporter saw that the produced azvudine APIs were neatly placed. waiting to be transported to the finished product manufacturing plant for the azvudine drug.
The reporter learned that the azvudine API needs to be stored in a special warehouse below 25℃, so as not to affect the stability of the drug.
According to He Bin, at present, the azvudine API production line of Xinxiang Pharmaceutical Co., Ltd., a subsidiary of Tuoxin Pharmaceutical Co., Ltd., has all the conditions for mass production and has been able to continue production to meet market demand. In the future, the production pace will be adjusted according to market conditions.
News 1+1: Review of Real Biological R&D History
What kind of business is Real Creatures?
It is understood that Real Bio 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 anti-virus, anti-tumor, cardiovascular and cerebrovascular and liver diseases. development of innovative drugs. The Series A financing will be completed in November 2020.
In July 2021, Azvudine Tablets, a Category 1 innovative drug developed and produced by Real Biotech with independent intellectual property rights, passed the priority review and approval process of the State Drug Administration and was officially approved for marketing.
In August 2021, Real Bio announced the completion of a Series B financing of US$100 million for product development, clinical project registration and commercialization of the approved new anti-AIDS class 1 drug Azvudine expansion, etc.
According to the information released by Real Bio at that time, in addition to the approval of the new AIDS class 1 drug Azvudine, the clinical trials of Real Bio Azvudine in the treatment of new coronary pneumonia have been fully advanced in China, Brazil and Russia .
In September 2021, Real Biology stated in its official WeChat account: “As early as the beginning of the outbreak of the new crown pneumonia in 2020, Azvudine has carried out related explorations for the treatment of COVID-19, and in preliminary clinical trials. In the test, the first nucleic acid conversion rate of 10 patients reached 90% within 4 days.”
Dahe Daily, Dahe Caifang reporter learned that Azvudine has won the Chinese Patent Gold Award and was officially awarded last year. It has been approved for marketing, achieving a breakthrough of zero approval and marketing of Class 1 innovative drugs in Henan Province. In October last year, as one of the scientific and technological achievements, it appeared at the National “Thirteenth Five-Year Plan” Scientific and Technological Innovation Achievement Exhibition.
In October 2021, the first batch of provincial industrial research institutes and pilot test bases in Henan will be unveiled.
Editor in charge: Wang Shidan | Reviewer: Li Zhen | Director: Wan Junwei