On 21 March, Fujian Cosunter Pharmaceutical Co.,Ltd. announced that the registered clinical study data of its anti-neocoronavirus oral small molecule 3CL protease inhibitor Class I innovative drug Atetevir Tablets/Ritonavir Tablets Combination Package (trade name: Tazovid®) will be published in eClinicalMedicine, a sub-journal of the authoritative international medical journal The Lancet. This signifies that China's anti-new coronary infection drug research and development is about to enter a brand new stage, contributing new results and solutions to China and even the global anti-new coronary infection healthcare.
This publication is a high recognition of the research results from the international academic community. The authors of the article are Academician Nanshan Zhong, Professor Hongzhou Lu (Member of the American Academy of Microbiology), Academician Fusheng Wang, Professor Xiaochun Chen, Dr Yuhua Zhang (General Manager of Akeylink), Dr Weizhong Mao (Chief Scientist of Akeylink), etc.
The study, to be published in eClinicalMedicine, a sub-journal of The Lancet, is a randomised, double-blind, placebo-controlled Phase II/III clinical study in China, led by the First Hospital of Guangzhou Medical University and the Third People's Hospital of Shenzhen, with the participation of a wide range of 48 clinical centres in the country and a total of 1,246 subjects. The results of the study showed that Tazovid® demonstrated significant antiviral effects, with a significant reduction in viral load and rapid recovery of 11 new crown symptoms, including "coughing, feeling hot or feverish, headache, and body pains/soreness", and was well tolerated and safe. Compared with Paxlovid, this super 3CL inhibitor, Tazovid®, has a lower dose (half the dose, 150mg, BID), the lowest daily therapeutic dose of a marketed global anti-neocoronate innovator, and a superior safety profile. It is also the only anti-neocoronary drug that has been approved and marketed both domestically and internationally that has demonstrated superior efficacy and statistically significant difference in the XBB variant population in a pivotal registry-based clinical study.
Based on the results of this study, Tazovid® was conditionally approved in China on 23 November 2023 for the treatment of adult patients with mild to moderate neocoronavirus infection.
The Lancet is one of the world's four leading medical journals. eClinicalMedicine is The Lancet's premier open access journal for integrative medicine research and is part of The Lancet Discovery Science. It publishes clinical research across all medical disciplines: from diagnosis to treatment, from prevention to palliative care, from health promotion to health policy and equity. The journal publishes high-quality clinical research with an emphasis on novelty and clinical progress, including original research articles and reviews. The Lancet-eClinicalMedicine has formally accepted the publication of the data from the clinical study of the atetevir/ritonavir tablet combination package (trade name: Tazovid®) after several rounds of review and selection by professional reviewers. This is a full affirmation of the potent antiviral efficacy, low dosage and excellent safety of Tazovid®, which will facilitate the recognition and development of Tazovid® in the international market for the benefit of patients with new crowns around the world.
At present, Tazovid® has been approved to be included in the National Temporary Medical Insurance, which significantly reduces the "economic threshold" for clinical application of the drug, benefiting patients at home and abroad.
