Boehringer and BeiGene break new ground with China approval

30 December 2019

Germany’s Boehringer Ingelheim, a privately-held drugmaker, has become the first company to apply the adopted Marketing Authorization Holder (MAH) system within China’s revised Drug Administration Law (DAL).

Boehringer is providing manufacturing services for BeiGene’s (Nasdaq: BGNE) monoclonal antibody tislelizumab, a checkpoint inhibitor, which was approved for the treatment of Hodgkin lymphoma patients who have already received at least two lines of treatment.

The outcome marks a milestone in the firm’s collaboration with the Chinese biotech, and an upturn in prospects for the product, after Celgene’s decision to hand back global ex-Asian rights to the candidate earlier in 2019.

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