7On July 15, Real Bio announced that the results of the phase III clinical trial of Azivudine Tablets for the treatment of new coronavirus pneumonia indications met expectations. Recently, a marketing application has been officially submitted to State Food and Drug Administration . This means that the drug is one step closer to becoming the first domestic oral drug for COVID-19.
Industry insiders believe that COVID-19 drugs are an important part of supplementing normal epidemic prevention and control, will provide support for domestic epidemic prevention and control, and are expected to help resume work and production and return the economy to normal operation.
What kind of medicine is Azivudine ? According to
information, Real Biotechnology was established in 2012. It is an innovative drug research and development enterprise integrating independent research and development, production and sales. It is committed to the research and development of innovative drugs for anti-viral, anti-tumor, cardiovascular and cerebrovascular and liver diseases.Azivudine is a broad-spectrum antiviral drug with independent intellectual property rights. It was initially used to treat AIDS. On July 21, 2021, it was conditionally approved for marketing by the State Food and Drug Administration. It is a new nucleoside A reverse transcriptase-like and auxiliary protein Vif inhibitor is also the world's first dual-target innovative anti-AIDS drug.
After the outbreak of the epidemic in 2020, Real Biotechnology launched research on Azivudine to treat COVID-19; in April of the same year, Real Biotechnology launched clinical trials after obtaining the domestic COVID-19 Phase III clinical approval of Azivudine; in the first quarter of 2021 It has successively obtained phase III clinical approval documents for in Brazil and in Russia.
On April 16, 2022, Jiang Jiandong, president of the Institute of Materia Medica, Chinese Academy of Medical Sciences, reported at the China Medical Development Conference the progress of the Phase II clinical study of Azivudine: Oral administration of Azivudine can reach nucleic acid levels in 3-4 days. After turning negative, the average medication time is 6-7 days, and the average discharge time is 9 days. The treatment effect for severe and mild cases is similar, and it is also effective for patients who are ineffective with other drugs.
Currently, the Phase III clinical trials of Azivudine for patients with moderate to severe COVID-19 in China, Russia, and Brazil have been completed.
On July 15, Real Biotech stated that the key phase III registration clinical trial supporting Azivudine’s marketing application adopted a multi-center, randomized, double-blind , placebo-controlled clinical trial design. The clinical trial results showed:
Significantly improve clinical symptoms: Azivudine tablets can significantly shorten the symptom improvement time of patients with moderate new coronavirus infection pneumonia, increase the proportion of patients with improved clinical symptoms, and achieve clinical superior results. The proportion of subjects whose clinical symptoms improved on the 7th day after the first administration was 40.43% in the Azivudine group and 10.87% in the placebo group (P value 0.001). The median time to improvement of clinical symptoms in the Azivudine group and There was a very significant statistical difference in the placebo group (P value 0.001). (PPS collection)
inhibits the new coronavirus: Azivudine has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days. In terms of
safety: Azivudine tablets are generally well tolerated. There is no statistical difference in the incidence of adverse events between the Azivudine group and the placebo group, and there is no increased risk to the subjects.
The production layout has already been advanced
Real Biotechnology is an unlisted company, but because Real Biotechnology is in the first echelon of domestic COVID-19 oral drug research and development, it is expected to become the first domestically produced COVID-19 oral drug. Therefore, in the past year, Real Life’s A share “circle of friends” has attracted much market attention.In the first half of this year, Real Biotechnology has reached cooperation agreements with China Resources Shuanghe, Xinhua Pharmaceutical , and Aoxiang Pharmaceutical. The cooperation content covers the research and development, production, and distribution of Azivudine. So far, Aziv The three designated production and dealer members gradually surfaced.
Xinhua Pharmaceutical announced on April 26 that it had signed a strategic cooperation agreement with Real Biotechnology to serve as a manufacturer and distributor of Azfudine products in China and other countries; China Resources Shuanghe announced on May 9 that it had signed a strategic cooperation agreement with Real Biotechnology. framework agreement for the entrusted processing and production of Azfudine tablets ; Aoxiang Pharmaceutical announced in May that its wholly-owned subsidiary Qizheng Pharmaceutical signed a commissioned processing and production framework agreement with Real Biotechnology for the processing and production of Azivudine tablets.
As a manufacturer of Azivudine API, the investor relations activity record sheet released by Tuoxin Pharmaceutical on May 26 shows that its subsidiary Xinxiang Pharmaceutical Azivudine API passed the agreement with Aziv Xinxiang Pharmaceutical has the corresponding production qualifications for the related review of customized dosage forms. The new production line of Azivudine API has achieved mass production, and the production plan has been advancing steadily and rapidly. The current production capacity of the production line can meet the needs of the market and customers. In the future, production will be arranged in an orderly manner based on market demand and order conditions.
In addition, the official website of the State Food and Drug Administration released the domestically produced drug registration information on June 29, which showed that Real Biotech has registered Azivudine tablets. The content of the filing is to update the name or address of the manufacturer stated in the drug registration approval document due to changes in the drug production license . Judging from the changes in the filing information, the manufacturer of Azivudine tablets was changed from Beijing Union Medical College to Henan Real Biotechnology Co., Ltd. and Beijing Union Medical College Co., Ltd., indicating that Real Biotech can entrust other pharmaceutical companies to produce Azivudine. , and it already has the qualifications to produce Azivudine on its own.
What other domestically produced oral COVID-19 drugs are being developed?
Azivudine is a small molecule oral drug for COVID-19. Most of the action mechanisms of small molecule oral drugs for COVID-19 are to achieve the effect of eliminating the virus by interfering with the replication of the virus itself. Currently, the world's main targets are RdRp and 3CLpro. Azivudine belongs to former.According to incomplete statistics from China Securities News reporters, there are more than 10 companies in my country that have deployed oral drugs for COVID-19, and the research and development of a number of oral drugs for COVID-19 are currently in the mid-to-late stage.
Junshi Bio announced on the evening of May 23 that the oral nucleoside anti-SARS-CoV-2 drug VV116, a product jointly developed by its holding subsidiary Juntuo Biotechnology and Wangshan Wangshui, was tested in a study comparing Nematvir tablets/Litto. The Phase III registration clinical study of Navir tablets (PAXLOVID) for the early treatment of mild to moderate novel coronavirus pneumonia achieved the primary endpoint preset in the protocol. The company will communicate with regulatory authorities in the near future to submit new drug marketing applications.
Kaoru Pharmaceutical announced on April 6 the key data results of the global multi-center phase III clinical trial of its oral COVID-19 drug proxalutamide in the treatment of mild and moderate COVID-19. It stated that it will actively promote the development of national drugs in China, the United States and other countries and regions. Supervisory agencies apply for emergency use EUA authorization.
In addition, recently, many companies have made new progress in the research and development of oral drugs for COVID-19. Sinovac Pharmaceutical announced on the evening of June 23 that the clinical trial registration application for SHEN26 capsule, a small molecule oral drug for COVID-19 developed in cooperation with Shenzhen Antaiwei Biopharmaceutical Co., Ltd., was accepted by the National Medical Products Administration; Zejing Pharmaceutical announced on June 15 that, The clinical trial of the company's independently developed Jacketinib Hydrochloride Tablets for the treatment of patients with severe new coronavirus pneumonia has been approved, and Phase II clinical research will be carried out; on June 13, Simcere Pharmaceuticals and Shanghai Institute of Materia Medica, Chinese Academy of Sciences The Phase II clinical study of the anti-new coronavirus candidate drug (SIM0417) jointly conducted by and Wuhan Institute of Virology has completed the administration of the first patient in Shanghai.
Image source: China Securities News reporters compiled
based on brokerage research reports and listed company announcements. Source: China Securities News
Original title: Sprinting on the first domestically produced COVID-19 oral drug! This company submitted an application for listing, and there are these A-share companies in "Moments"
