China approves BeiGene's tislelizumab for Hodgkin's lymphoma

Sino-America biotech firm BeiGene (Nasdaq: BGNE) says that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies.

The new drug application (NDA) was previously granted priority review by the NMPA. Following the recent approval of Brukinsa (zanubrutinib) by the US Food and Drug Administration, tislelizumab is BeiGene’s first drug approved in China.

Developed by BeiGene scientists, tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.