The first domestic anti -new crown oral drug attachment condition was approved for listing real creatures to take the lead

Our reporter Zhang Min, a trainee reporter Xu Linyan

On July 25, the State Drug Administration issued the "Emergency Conditions Approval of Henan True Biotechnology Co., Ltd. Azf Fixed Pixel to Add New Crown Pneumonia Therapy Application". For emergency review and approval, it is attached to the conditions of Henan True Biotechnology Co., Ltd. (hereinafter referred to as "real creature") Azf's fixed chip to increase the application for the treatment of new coronary virus pneumonia.

According to the State Drug Administration, this product is the treatment of oral small molecular virus pneumonia therapy drugs independently developed by 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.

On July 15th, the real creature announced that the results of Azf's fixed tablet for the treatment of new coronary virus pneumonia indicated that the results of the phase III clinical trials reached expectations. Recently, it has officially submitted a listing application to the State Drug Administration.

The results of clinical trials show that Azf's fixed tablet can significantly shorten the moderate new type of coronary virus infection with pneumonia patients, improve the proportion of patients with improvement of clinical symptoms, and achieve clinical excellent results. On the first 7th day of the administration, the proportion of the subjects of the clinical symptoms improved 40.43%, and the placebo group was 10.87%(P value <0.001). There are very significant statistical differences with the placebo group (P value <0.001). Azf has the effect of inhibiting the active activity of the new coronary virus, and the virus clearance time is about 5 days.

Real creatures have previously paved the way for the production and commercialization of Azf. Since April this year, real creatures have signed cooperation agreements with A -share listed companies Xinhua Pharmaceutical, China Resources Shuanghe, and Aoxiang Pharmaceutical. On June 29, the filing information of Azf's fixed film was changed, and the name of the manufacturer was changed from Beijing Union Pharmaceutical Factory to Henan Real Biotechnology Co., Ltd. and Peking Union Pharmaceutical Co., Ltd. This means that the real creature is a listing license holder of the Azf's fixed film, and has also obtained the production license qualification of Azf's fixed production.

Dr. Dr. Du Jinfa, a real creature CEO and CSO, said: "This is the first domestic new crown oral medicine to be approved for listing. I hope that Azf will make a solid power to fight against the new crown epidemic."

Prior to this, Pfizer's PaxLovid was the only new crown small molecule oral medication in the Chinese market. Who has been paying attention to who has always received much attention. The real creatures of Azfding, the VV116 of the Junshi creature, and the Puklunamide of the pioneering pharmaceutical industry are the "popular players" in the first echelon. After the real creature Azf was approved for the treatment of the proper to treat ordinary new coronary virus pneumonia, the market progress of other "players" also attracted attention.

On July 25, the National Pharmaceutical Supervision and Management Television Conference was held. Jiao Hong, director of the State Drug Administration, summarized the medical supervision work in the first half of the year in his speech and made specific arrangements for the second half of the year. Among them, it was proposed to fully serve the overall situation of the epidemic prevention and control, coordinate emergency approval and quality supervision, accelerate the treatment of new crown virus treatment Drug research and development speed, strengthen innovation services and quality supervision of new coronary vaccine vaccine, ensure the safety and effectiveness of the new coronary virus detection test agent, and strengthen the quality supervision of the entire chain of anti -epidemic prevention and medical device.

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