The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered COVID-19 small-molecule therapies: SIM0417 from Hainan Simcere Pharmaceutical Co., Ltd, and VV116 from Shanghai JunTop Biosciences Co., Ltd. JunTop is a joint venture (JV) between Junshi Biosciences and Vigonvita Life Sciences Co., Ltd.
SIM0417: Next-Generation COVID-19 Therapy
SIM0417 is considered a potential next-generation oral COVID-19-specific drug, demonstrating strong inhibitory effects against various COVID-19 variants. Preclinical studies in animal models showed good antiviral activity and a favorable safety profile against the key protease 3CL necessary for coronavirus replication. Simcere secured a licensing deal with the Chinese Academy of Science’s Shanghai Institute of Materia Medica (SIMM) and the Wuhan Institute of Virology in November 2021, obtaining exclusive global rights for the drug’s development, manufacturing, and commercialization. A market approval filing in China was submitted on January 16, 2023.
VV116: Deuterated Remdesivir Hydrobromide
VV116 is a deuterated remdesivir hydrobromide with potent activity against SARS-CoV-2, demonstrating satisfactory safety and side-effect profiles in Phase I trials. The drug was co-developed by the Shanghai Institute of Materia Medica (SIMM), Wuhan Institute of Virology, and other research institutes. Junshi established the JV with Vigonvita, a specialist in neuropsychiatric and infectious diseases, in October 2021. The market filing for VV116 was submitted on January 18, 2023.
Reimbursement Policies for COVID-19 Treatments
According to the “Optimizing Relevant Medical Insurance Policies for Treatment Expenses of Patients with Novel Coronavirus Infection” jointly issued by the National Healthcare Security Administration (NHSA), Ministry of Finance, National Health Commission, and Chinese Center for Disease Control and Prevention in January 2023, insured patients will receive at least 70% reimbursement for outpatient and emergency expenses related to COVID-19, with no baseline or ceiling payment.-Fineline Info & Tech
