Two innovative oral anti-new coronavirus drugs are conditionally listed, both developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences – Xinhua English.news.cn

Caption: State Food and Drug Administration website information source/network screenshot

Xinmin Evening News (Reporter Gao Yang) On January 29, 2023, the official website of the State Food and Drug Administration issued an announcement, conditionally approving the marketing of two new coronavirus infection treatment drugs. Both drugs were developed by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. They are oral small-molecule novel coronavirus infection drugs for the treatment of adult patients with mild to moderate novel coronavirus infection (COVID-19).

At the same time, 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 follow-up research results in a timely manner.

Caption: Schematic diagram of the mechanism of action of VV116 Source/Picture provided by the interviewee (the same below)

Mindavit, an innovative oral anti-new coronavirus drug independently developed by my country^®（VV116）

On the 29th, the new oral nucleoside anti-new coronavirus drug Mindevir^®(Deuterium Remidevir Hydrobromide Tablets, VV116) has passed the special approval process of the State Drug Administration and has been conditionally approved for marketing for the treatment of adult patients with mild to moderate novel coronavirus infection (COVID-19). This is an anti-new coronavirus oral drug independently developed by my country that targets the RNA-dependent RNA polymerase (RdRp) of the new coronavirus.

The drug was jointly researched by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of Physics and Chemistry, Chinese Academy of Sciences, and Suzhou Wangshan Wangshui Biomedicine Co., Ltd. (Wangshan Wangshui) to identify new drug candidate molecules. Through cooperation with the Central Asia Drug Research and Development Center of the Chinese Academy of Sciences/China-Ukraine Medical Science and Technology City (Ministry of Science and Technology “Belt and Road” Joint Laboratory), Lingang Laboratory, Wangshan Wangshui, and Shanghai Junshi Biomedical Technology Co., Ltd. to jointly promote Clinical research and marketing authorization.

After the outbreak of the new crown epidemic at the end of 2019, the Shanghai Institute of Materia Medica immediately established a joint anti-epidemic research team, and worked closely with the Wuhan Institute of Virology to start emergency research and development of anti-epidemic drugs. Shen Jingshan/Jiang Hualiang’s team from Shanghai Institute of Materia Medica, Xiao Gengfu’s team from Wuhan Institute of Virology, and Xinjiang Institute of Physics and Chemistry’s Aji Aikebaier Aisa team quickly discovered and evaluated an oral nucleoside candidate compound VV116 targeting RdRp, namely deuterium hydrobromide Midway. VV116 non-covalently binds to the active center of the new coronavirus RdRp in the form of nucleoside triphosphate, directly inhibits the activity of the virus RdRp and interferes with the synthesis of RNA, thereby blocking the replication of the virus and realizing the anti-new coronavirus effect.

Preclinical research results show that VV116 exhibits significant antiviral effects on the original and mutant strains of the new coronavirus, including Omicron. In the mouse model of SARS-CoV-2 infection, VV116 can effectively clear the virus and significantly improve the pathological changes of lung tissue. VV116 has no risk of mutagenesis, no risk of serious adverse reactions caused by interaction with other drugs, and has advantages in terms of safety.

Based on the results of clinical trials conducted in subjects with moderate to severe COVID-19 in Uzbekistan, VV116 was approved for marketing in Uzbekistan on December 28, 2021, becoming the world‘s first drug approved for the treatment of patients with severe COVID-19 infection Oral antiviral drugs.

A number of preclinical and clinical studies have shown that VV116 is safe and effective, with few drug contraindications. Its approval for marketing will effectively reduce the threat of the new coronavirus to people’s lives and health, and play an important role in my country’s epidemic prevention and treatment system.

Caption: Xiannuoxin

The first domestic innovative drug targeting 3CL protease oral anti-coronavirus Cenoxin^®

On January 29, the innovative anti-coronavirus drug Senoxin jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences and Simcere Pharmaceuticals^®Through the special approval process of the State Drug Administration, it was conditionally approved for marketing for the treatment of adult patients with mild to moderate novel coronavirus infection (COVID-19). This is my country’s first self-developed anti-new coronavirus oral drug targeting 3CL protease.

Sennoshin^®It is a combination packaged drug of Xiannotevir tablets and Ritonavir tablets. Xiannotevir can inhibit the 3CL protease necessary for the replication of the new coronavirus, and when used in combination with low-dose ritonavir, it can slow down the metabolism of Xiannotevir in the body and help exert its antiviral effect.

After the outbreak of the new crown virus, the Shanghai Institute of Materia Medica immediately established an anti-epidemic research team, and cooperated with the Wuhan Institute of Virology to carry out emergency research and development of anti-new crown virus infection therapeutic drugs. Shen Jingshan/Xu Yechun/Jiang Hualiang’s team from Shanghai Institute of Materia Medica and Xiao Gengfu’s team from Wuhan Institute of Virology cooperated to quickly discover and determine the candidate compound VV934 targeting 3CL protease, ie notavir. Preclinical research results show that cenotevir can selectively inhibit the 3CL protease of the new coronavirus; combined with ritonavir, it can effectively inhibit the replication of the virus in the lungs and brains of mice, and significantly reduce the lung damage caused by the virus infection. Tissue damage; In the in vivo and in vitro safety evaluation tests, no genetic toxicity was found.

In November 2021, the Shanghai Institute of Materia Medica, Wuhan Institute of Virology and Simcere reached a cooperation to advance the follow-up research and development of cenotevir at full speed.Sennoshin^®Its phase III clinical trial is the first at home and abroad to achieve the primary endpoint of “sustained recovery of 11 symptoms including cough, nasal congestion, sore throat, fever, headache, muscle or general pain” for patients infected with Omicron strain A total of 1,208 subjects from 43 participating clinical research centers in 20 provinces, municipalities and autonomous regions across the country were included in the Phase III clinical trial.

Sennoshin^®The approval for marketing of the drug provides a new option for the clinical treatment of new coronavirus infection, and will play an important role in my country’s epidemic prevention and treatment system.

Xinmin Evening News reporter Gao Yang