BeiGene’s PD-1 Antibody Accepted for NDA Review in China

Published on: Aug 31, 2018
Author: Amy Liu

Beijing’s BeiGene reported that the National Medical Products Administration of China (NMPA, formerly known as CFDA or CDA) has accepted the company’s new drug application for tislelizumab, a PD-1 antibody, as a treatment for relapsed/refractory classical Hodgkin’s lymphoma. In a pivotal Phase II trial, tislelizumab produced an 87% overall response rate and a 61% complete response rate at a median of eight months follow up.

Source: China Biotoday

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