China Approves BeiGene for Commercial Manufacturing at its Biologics Facility

BioPharm International Editors

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

BeiGene, a commercial-stage biotechnology company, announced on April 7, 2021 that the China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-programmed cell death (PD)-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

The 1 million-ft.2 facility currently has 8000 Lof biologics capacity approved for commercial supply, with 64,000 additional liters planning to be added to the site by the end of 2022, BeiGene said in a company press release.

“We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand. Since that time, tislelizumab has been approved in several indications in China, included in the National Reimbursement Drug List, and licensed to Novartis in Europe, North America, and Japan,” said Xiaobin Wu, PhD, president, chief operating officer, and general manager of China at BeiGene, in the press release. “With significantly expanded capacity for tislelizumab and for other biologics in our pipeline, we are continuing our strong commitment to the quality, safety, and compliance of our products.”

Source: BeiGene