China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for SIM0417 into its special review channel. The oral COVID-19 drug candidate is co-developed with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology. The intended indication is for the treatment of mild to moderate COVID-19 infections.
SIM0417: Development and Clinical Trials
SIM0417 is considered a potential next-generation oral COVID-19-specific drug with strong inhibitory effects against various COVID-19 variants, including the Delta strain. Preclinical studies demonstrated good antiviral activity and a favorable safety profile against the key protease 3CL necessary for coronavirus replication. Simcere secured a licensing deal with SIMM in November 2021, obtaining exclusive global rights for the drug’s development, manufacturing, and commercialization.
Clinical trial approvals were granted in March and May 2022 for evaluating SIM0417 in mild to moderate COVID-19 infections and post-exposure prophylactic treatment, respectively. A Phase III regulatory study assessed the drug in patients infected with the Omicron variant, with the primary endpoint being the “continuous recovery of 11 symptoms, including cough, nasal congestion and runny nose, sore throat, fever, headache, and muscle or systemic pain.” Results from 1,208 patients will be revealed post-approval.
Future Outlook
With NMPA’s acceptance into the special review channel, SIM0417 is poised to advance through the regulatory process. This development underscores Simcere’s commitment to addressing significant unmet needs in COVID-19 treatment and highlights the potential of SIM0417 as a new therapeutic option.-Fineline Info & Tech
