New Designations Set To Speed Hemlibra, CAR-T In China
RSV Antiviral Also Benefits
China is set to grant priority reviews to major biologics from Roche, the first CAR-T therapy from Wuxi Juno, and breakthrough therapy designation to a pediatric respiratory antiviral from ArkBio.
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Founded five years ago, Shanghai-based Ark Bio sees big potential in the less crowded pediatric antiviral treatment market. Now the start-up is in Phase II development for its lead asset ziresovir for respiratory syncytial virus (RSV) infection, which was licensed from Roche.
Touting its coronavirus vaccines as a "global public good", China is quietly preparing for the first general approvals and launches, possibly within weeks, developers say. But who will be first in line to receive them? And at what cost? Distribution and pricing are just some of the unanswered questions.
China’s National Medical Products Administration has released key regulations and proposals designed to encourage first generics through a 12-month market exclusivity proposal.