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BeiGene Gains Commercial Manufacturing Approval for Guangzhou Biologics Facility

Biotechnology company BeiGene has announced approval from the China National Medical Products Administration (NMPA) to commence the manufacturing of tislelizumab, its anti-PD-1 antibody. This is to begin immediately at its million square foot biologics facility in Guangzhou, China.

This is China’s first paperless biological manufacturing facility, integrating up-and-coming technologies like 3D modelling, digital twin, augmented interfaces, and AI to improve quality and efficiency.

“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 (NRDL), and licensed to Novartis in Europe, North America and Japan.”

Dr. Xiaobin Wu, BeiGene’s President, Chief Operating Officer, and General Manager of China

BeiGene’s Guangzhou facility has been designed to operate in compliance with current Good Manufacturing Practice (cGMP) standards adopted by the U.S. FDA, the NMPA and the European Medicines Agency (EMA). Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcyR on macrophages. It is being developed internationally as a monotherapy and in combination with other therapies to treat a wide array of both solid tumour and hematologic cancers.

Tislelizumab has been given full approval by the NMPA for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. It has received conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, as well as patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Full approval depends on results from ongoing clinical trials.

The Centre for Drug Evaluation (CDE) of the NMPA has accepted and is reviewing three supplemental Biologics License Applications for tislelizumab for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who
progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.
Tislelizumab is approved for use outside of China.

(Source: BioPharma Reporter, 2021)