Under new rules specifically for the launch of COVID-19 therapeutics in China, US-based Merck Sharp & Dohme (MSD, NYSE: MRK) has proactively submitted the initial quotation and materials for its molnupiravir, the world’s first oral COVID-19 therapy. The Tianjin Medical Purchasing Center has publicized the quoted price at RMB 1,500 (USD 221) per box (0.2g, 40 tablets/box).
Mechanism and Clinical Impact
Molnupiravir, a prodrug of ribonucleoside analog β-D-N4-hydroxycytidine (NHC) co-developed by Ridgeback Therapeutics, is active against coronavirus and other RNA viruses. Its pharmacological mechanism involves interfering with the genetic coding of the virus to introduce mistakes and prevent virus replication. Trial data show that the drug reduces the risk of hospitalization for patients by 50%.
Global and Chinese Approvals
Molnupiravir received Emergency Use Authorization (EUA) in the US in December 2021 for use in COVID-19-positive adult patients with a high risk of disease progression who are unable to obtain or are not clinically suitable for other therapies. The drug has since gained marketing authorizations in 40 countries and regions. As of December 2022, MSD has supplied 9 million courses of the drug worldwide, treating 2.7 million patients.
Chinese Market Approval
China’s National Medical Products Administration (NMPA) issued an emergency use nod for molnupiravir in December 2022, approving it for the treatment of adult patients with mild to moderate COVID-19 who have disease progression and severe high-risk factors such as old age, obesity or being overweight, chronic kidney disease, diabetes, serious cardiovascular disease, chronic obstructive pulmonary disease, active cancer, and others.
Future Outlook
The submission of the initial quotation for molnupiravir in China marks a significant step in making this groundbreaking therapy available to patients in the country. With its demonstrated efficacy in reducing hospitalization risks and its broad global approval, molnupiravir is poised to play a crucial role in the ongoing fight against COVID-19. MSD’s proactive approach underscores its commitment to expanding access to this essential treatment.-Fineline Info & Tech
