China tests marketing authorization holder system and Boehringer gets the first deal

The German family-owned pharma major Boehringer Ingelheim will soon produce a monoclonal antibody (MAb) BGBA317 in its Shanghai facility for the Beijing-based biotech company BeiGene through a contract manufacturing deal, reports The Pharma Letter’s local correspondent Wang Fangqing.

BGBA317 targets PD-1, a cell surface receptor which could down-regulate the immune system by obstructing T-cell’s cancer killing ability. The MAb is now under Phase I clinical studies in Australia targeting patients with relapsed or refractory solid tumors. In January, the MAb gained Investigational New Drug approval from the US Food and Drug Administration.

According to Boehringer, its biopharmaceutical CMO service in Germany has been working with BeiGene on supplying BGBA317. In 2014, the two companies signed an agreement, under which Boehringer will produce the MAb in China for the global market.