Health & Beauty

According to the website of the State Food and Drug Administration, on July 25, the State Food and Drug Administration conducted emergency review and approval in accordance with the relevant provisions of the "Drug Administration Law" and in accordance with the special drug approval procedures, and approved Henan True Biotechnology Co., Ltd. Azvudine with conditions. The tablet has increased the registration application for the treatment of new coronavirus pneumonia.

This product is an oral small molecule novel coronavirus pneumonia treatment drug independently developed by my country. On July 20, 2021, the State Food and Drug Administration has conditionally approved this product in combination with other reverse transcriptase inhibitors for the treatment of adult HIV-1 infected patients with high viral load. This is a conditional approval of an additional indication for the treatment of adult patients with common novel coronavirus pneumonia (COVID-19). Patients should strictly follow the instructions for medication under the guidance of a physician.

The State Food and Drug Administration requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in a timely manner.

The results of the pivotal Phase III registration clinical trial supporting the launch of Azvudine Tablets for the new coronary pneumonia indications show that Azivudine Tablets can significantly shorten the time for symptom improvement in patients with moderate new coronary pneumonia, increase the proportion of patients with improved clinical symptoms, and achieve clinical excellence. effective results. In terms of inhibiting the new coronavirus, Azvudine has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days. In terms of safety, Azvudine tablets were generally well tolerated, and there was no significant difference in the incidence of adverse events between the Azvudine group and the placebo group, and did not increase the risk of subjects.

Azvudine will be very cheap. According to the disclosed public data, the cost of a course of azvudine is about 35 yuan. Even if the R&D expenses and corporate profits are included, if the listing price is expanded by 10 times, the price will only be 350 yuan, which is only Pfizer's special effect. one-seventh of the medicine. After being actually included in the medical insurance, the price of azvudine is very likely to be around 100 yuan, which is similar to the price of many common cold medicines. Once azvudine is approved for marketing, its price will be the cheapest of all the current new crown medicines.

Professor Chang Junbiao, the inventor of azvudine, the former president of Henan Normal University, and the current deputy secretary and vice president of Zhengzhou University, has previously stated that Azvudine is a nucleoside that inhibits viral RNA-dependent RNA polymerase (RdRp). The analogs can specifically act on the new coronavirus RdRp, thereby inhibiting virus replication, and its drug targeting is strong.

At the end of April and early May of this year, Real Biology has signed commercial cooperation agreements with Xinhua Pharmaceutical, China Resources Double Crane and Aoxiang Pharmaceutical respectively. Among them, Xinhua Pharma has obtained the production and distribution rights of real biological azvudine and other products in China and other countries agreed by both parties; China Resources Shuanghe has become the entrusted processing and production enterprise of azvudine tablets; Aoxiang Pharmaceutical Co., Ltd. On the other hand, Zhejiang Qizheng Pharmaceutical, a wholly-owned subsidiary of its subsidiary, signed the "Framework Agreement on Entrusted Processing and Production" and "Quality Agreement on Entrusted Production of Drugs" with Real Biology. As one of the fastest-growing domestic oral drugs for COVID-19, the listing progress of Real Bio's azvudine tablets has always attracted much attention.

As of now, there are more than 20 oral medicines for COVID-19 in development around the world. According to data from the Smart Bud Global New Drug Intelligence Database, as of June 30, four oral drugs for COVID-19 had been approved in the United States, namely Pfizer's Paxlovid (Nimatvir/ritonavir) and Merck's Molnupiravir (Monuclear). Pivoxil), Gilead's Remdesivir (Remdesivir), and Eli Lilly's Olumiant (baricitinib). Among them, Pfizer's Paxlovid was approved for import in China in February this year with conditions, priced at 2,300 yuan per box, and has since been included in medical insurance. In terms of health insurance, Meixin Health and Shanghai Pharmaceuticals also jointly launched the Kangfu Health Pass Epidemic Prevention Rights Card (Shanghai version) on the Kangfu Health platform, which includes Paxlovid in the scope of drug protection, further improving the availability of new crown drugs.

Azvudine is the first domestically-produced oral drug for COVID-19 approved in my country. In addition, there are more than 10 domestic enterprises including Kintor Pharmaceuticals, Junshi Bio, Simcere Pharmaceuticals, Ascles, and Genting Xinyao. Previously, industry insiders generally speculated that the first domestically produced oral drug for new coronary pneumonia would be produced in Real Bio's Azvudine, Kintor Pharmaceutical's Proclutamide, and Junshi Bio's VV116, and Real Bio finally came out on top.