Pharma Focus Asia

SIMCERE PHARMA (HK.2096) Novel Inhibitor of COVID-19 3CLpro SIM0417 Received a Second Clinical Trial Approval in China

Friday, May 20, 2022

SIMCERE PHARMA announced that SIM0417, a candidate drug against SARS-Cov-2, for which the Company holds license from Shanghai Institute of Materia Medica (SIMM) and Wuhan Institute of Virology, Chinese Academy of Sciences, has obtained the Clinical Trial Approval issued by the National Medical Products Administration in China, and is proposed for post-exposure prophylaxis for close contacts of individuals who test positive for SARS-CoV-2.

SIM0417 (molecule serial number SSD8432) targets 3CL protease, which is a key protease required for SARS-CoV-2 replication. It is currently under clinical development for SARS-CoV-2 infected patients. SIM0417 has shown broad-spectrum antiviral activity, good in vivo pharmacokinetic properties, and safety in pre-clinical studies. It is a highly active, low toxicity, orally administrable small molecule anti-SARS-CoV-2 drug candidate.

· On November 17, 2021, Simcere established the collaboration with SIMM, etc. on the co-development and commercialization of SIM0417.
· On March 28, 2022, the first Clinical Trial Approval in China is obtained, for SARS-CoV-2 infected patients.
· On April 10, 2022, first subject enrolled in phase 1 study accomplished in Shandong Provincial Qianfoshan Hospital.
· On May 13, 2022, the second Clinical Trial Approval is obtained, for post-exposure prophylaxis in close contacts of individuals who test positive for SARS-CoV-2.

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