China approves Merck's COVID-19 pill amid drugs shortage

Asian Tech Press (Dec 30) -- China has approved U.S. drug company Merck Sharp & Dohme Corp. (MSD)'s COVID-19 pill molnupiravir amid the shortage of drugs.

China's National Medical Products Administration (NMPA) on Friday conditionally approved the import registration of Merck's COVID-19 pill molnupiravir.

Molnupiravir became the third approved COVID-19 oral drug in China, following Pfizer Inc's Paxlovid and Genuine Biotech's Azvudine.

The approval of molnupiravir may ease concerns about drug shortages in China, where the number of infections has risen sharply nationwide since the lifting of COVID-19 restrictions that has lasted three years since early December.

Molnupiravir, an oral antiviral pill that inhibits coronavirus replication, was co-developed by Merck and Miami-based company Ridgeback Biotherapeutics LP.

Molnupiravir will be available in China for the treatment of adults with mild to moderate COVID-19 with risk factors for progression to severe disease such as advanced age, obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, active cancer and other high risk factors for severe disease.

Now, molnupiravir has gained marketing authorization or emergency use authorization in more than 40 countries or regions, including the United States, European Union, Australia, Japan and South Korea.

In September this year, Merck signed a cooperation framework agreement with Chinese state-owned drugmaker Sinopharm Group Co. Ltd., granting the distribution and exclusive import rights of molnupiravir in China to Sinopharm.

In November 2022, Merck signed a distribution agreement with a distribution agreement with a subsidiary of Sinopharm for the import and distribution of molnupiravir in China.

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