FDA completes inspection of BeiGene’s tislelizumab manufacturing facility and BLA progresses

Jul 18, 2023

BeiGene announced that the FDA has completed a GMP inspection of its tislelizumab manufacturing facility.  Tislelizumab is a PD-1 antibody and potential treatment for oesophageal squamous cell carcinoma (ESSC), and is being commercialised with Novartis.  The Company confirmed that the BLA is moving forward, and it is seeking to gain approval in the EU to treat ESSC, and approval in China to treat hepatocellular carcinoma.

Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.

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