China's domestically-developed oral COVID drug to enter market in February

(ECNS) -- SIM0417, an oral COVID drug developed by China, is expected to enter the market in February 2023, according to the Jiangsu Medical Products Administration.

SIM0417 (Xiannuoxin in Chinese), co-developed by Nanjing-based Simcere Group, the Shanghai Institute of Materia Medica and the Wuhan Institute of Virology under the Chinese Academy of Sciences, is a highly active small molecule candidate COVID-19 drug that targets the 3C-like protease, a key enzyme in the replication and life cycle of coronaviruses, including SARS-CoV-2.

Preclinical animal models have demonstrated good antiviral activity and safety of SIM0417. Due to the 3CL protease's highly conserved nature, SIM0417 has a strong inhibitory effect on a variety of SARS-CoV-2 variants, including the highly infectious Delta and Omicron.

It is available for the treatment of mild and moderate COVID-19 patients and prevention of severe COVID-19 symptoms.

The drug has been granted two approvals on March 28 and May 13, 2022 by Chinese authorities to start clinical trials for its efficacy to treat COVID-19 and prevent the virus in people with a high infection risk.

The phase III clinical study of the drug has completed all enrollment of 1,208 patients in December, the Simcere Group announced on Dec. 18.