Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
BEIJING – Cancer and autoimmune specialist Innocare Pharma Ltd., of Beijing, made a strong debut to raise $288 million on the Hong Kong Stock Exchange (HKEX) on March 23, marking the second biggest IPO in the city since the beginning of this year.
ORLANDO, Fla. – Not long past the opening of the American Society of Hematology’s (ASH) massive annual conference, Janssen Biotech Inc. released upbeat follow-up survivability data on Imbruvica (ibrutinib) from two studies and an integrated analysis evaluating Imbruvica in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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.
BEIJING – Cancer and autoimmune specialist Innocare Pharma Ltd., of Beijing, is seeking a pre-revenue listing on the Hong Kong Stock Exchange (HKEX) to raise capital to advance its BTK inhibitor, ICP-022, to an NDA filing in China by the end of this year.
