BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.

SHANGHAI – Although China still has a way to go to approve any CAR T therapy, clinical development is robust with various targets being studied, and the regulatory environment is improving, cell therapy experts said at the Chinatrials 12 Summit.  

HONG KONG – South Korean pharmaceutical giant Yuhan Corp. has invested ₩3 billion (US$2.6 million) in SL Bigen Co. Ltd., a Korean biotech based in Seongnam, Gyeonggi-do, that is focused on chimeric antigen receptor-directed natural killer (CAR-NK) therapy.

SHANGHAI – As Chinese biotech companies talk more about innovation, one question is whether they are ready to move into first-in-class drugs from me-too and fast follow-up drugs. To biotech executives, the China first approval for Fibrogen Inc.'s roxadustat, a first-in-class small molecule for amenorrhea, is a wake-up call.

SHANGHAI – Now is the time for foreign pharmaceutical companies to include China in their strategies, as the country's recent regulatory reform, vast patient pool and lower costs represent opportunities to score approvals faster, said experts at the Chinatrials12 Summit.