BeiGene (BGNE) [HK:06160], a Beijing oncology biopharma, announced US approval of its Bruton's tyrosine kinase candidate, Brukinsa™ (zanubrutinib), as a second-line treatment for adult patients with mantle cell lymphoma (see story). Brukinsa is the first BeiGene-discovered product to be approved. The approval was based on the candidate's overall response rate of 84% and complete response of 59%. BeiGene may be asked to conduct a confirmatory trial of Brukinsa. The company expects its second approval before the end of the year for China use of its PD-1 candidate.
BeiGene's PD-1 candidate tislelizumab was recommended for