New Approvals, Biosecurity In Spotlight As China Gears For National Congress
Proposed Law Gains Momentum Post-COVID-19
China grants new approvals to multiple new drugs for cancer and rare diseases, as the government gears up to hold its delayed annual congress in Beijing, attended by thousands of delegates who will vote on key new biosecurity legislation as the pandemic appears to be receding in the country.
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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 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.
China’s National Medical Products Administration has released key regulations and proposals designed to encourage first generics through a 12-month market exclusivity proposal.