Policy & Regulation
BeiGene awarded commercial manufacturing approval for state-of-the-art biologics facility in Guangzhou, China
8 April 2021 -

Biotechnology company BeiGene Ltd (NASDAQ:BGNE)(HKEX:06160) on Wednesday announced the receipt of China National Medical Products Administration's (NMPA) approval to begin commercial manufacturing of tislelizumab at its facility in Guangzhou, China.

At over 100,000 square meters and 8,000 litres of biologics capacity approved for commercial supply, the company's wholly owned state-of-the-art biologics facility will begin the commercial production of its approved anti-PD-1 antibody, tislelizumab, for the Chinese market.

By the end of 2022, the additional phase of construction, which is currently in progress, will bring the total biologics capacity to 64,000 litres, revealed the company.

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. Tislelizumab is the first drug from the company's immuno-oncology biologics programme and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumour and hematologic cancers.

The Guangzhou manufacturing facility operates in compliance with Good Manufacturing Practice (cGMP) standards adopted by the US Food & Drug Administration, the China National Medical Products Administration (NMPA) as well as the European Medicines Agency.

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