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Orphan Drug, Domestic Developers Shine In China Annual Approvals Tally

Half Of Priority Reviews For Homegrown Firms

 
• By Brian Yang

10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.

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China's domestic firms get more new drug approvals, NMPA report shows • Source: Shutterstock

According to the latest National New Drug Approval Report for 2023 from China's National Medical Products Administration (NMPA), 15 orphan drugs were approved through the regulator's designated priority review pathway.

The annual tally of approvals, released on 4 February, showed Nordic orphan drug development specialist Swedish Orphan Biovitrum AB scored the highest number of approvals for a single company, with three including Orfadin (nitisinone) for adult/pediatric hereditary tyrosinemia type 1

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