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.
From orphan to cancer drugs, more products have had their prices cut in the latest round of reimbursement negotiations in China. Although the 60% average across 100 medicines was considered mild given it didn’t go beyond the previous year, it was still chilling and is prompting more firms, both multinational and domestic, to walk away from the process.
For the first time in 61 years, China has reported its population is shrinking and the new demographic shift is likely to have a far-reaching impact on the pharma sector. Meanwhile, regulators have accelerated the approval of new COVID-19 drugs to relieve acute shortages.