Today (January 29), the State Food and Drug Administration issued an announcement saying: In accordance with the relevant provisions of the Drug Administration Law, in accordance with the special drug approval procedures, emergency review and approval, conditional approval of Hainan Simson Pharmaceutical Co., LTD., the first category of innovative drug Zenotvir tablet/Ritonavir tablet package (product name: Synoxin), Shanghai Wangshi Biological Medicine Technology Co., LTD., declared a class 1 innovative drug Deuterium hydrobromide Ramidvir tablets (trade name: Mindevir) on the market. Both drugs are oral small-molecule novel coronavirus infection therapeutics for the treatment of adult patients with mild to moderate novel coronavirus infection (COVID-19).
About Synocin
Synnotvir (Synnotvir tablet/Ritonavir tablet combination package) is an oral small-molecule anti-novel coronavirus innovative drug, in which synnotvir targets at 3CL protease necessary for SARS-CoV-2 virus replication. When combined with low dose of ritonavir, it can help slow the metabolism or decomposition of synnotvir in the body and improve the antiviral effect. In preclinical animal studies, Xenocin ® showed high potency, broad-spectrum activity against COVID-19, and no genotoxicity was found. On November 17, 2021, Simsun Pharmaceutical signed a technology transfer contract with Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology, obtaining the exclusive rights to the global development, production and commercialization of SIM0417.
As the first domestic 3CL anti-COVID-19 innovative drug with independent intellectual property rights, the successful launch of Synnoxine is expected to bring more effective treatment options for Chinese patients.
About Mindevi
VV116 is a new oral nucleoside antiviral drug, It was jointly developed by Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Wuhan Institute of Virology of the Chinese Academy of Sciences, Xinjiang Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences, Central Asian Drug Research and Development Center of the Chinese Academy of Sciences/China-Uzbekistan Medical Science and Technology City (" Belt and Road "Joint Laboratory of the Ministry of Science and Technology), Lingang Laboratory, Suzhou Wangshan Wangshui Biological Medicine Co., LTD. (Wangshan Wangshui) and Junshi Biology. Junshi Biologics and Wangshan Wangshui jointly undertake the clinical development and industrialization of this drug in the cooperation area, which covers the global scope except for five Central Asian countries, Russia, North Africa and the Middle East.
On December 29, 2022, The New England Journal of Medicine (NEJM), a global authoritative journal, has published online the VV116 (JT001), an oral nucleoside anti-novel coronavirus (SARS-CoV-2) drug, compared with Nematavir tablet/Ritonavir tablet combination (PAXLOVID), for mild to mild patients with severe progression including high risk factors of death Results of a Phase III clinical study on early treatment of patients with moderate novel coronavirus infection (COVID-19) (NCT05341609). This is the first clinical trial of a domestically developed novel coronavirus innovative drug published by NEJM.
With the approval of the above two products, there are now five novel coronavirus oral medicines on the market in China.
