BRIEF—China's NMPA accepts 12th regulatory submission for PD-1 inhibitor tislelizumab

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) submitted by BeiGene for tislelizumab in patients with first-line unresectable or metastatic hepatocellular carcinoma (HCC).

Hepatocellular carcinoma is the most common type of primary liver cancer worldwide and is associated with a very poor prognosis. New cases and deaths due to HCC in China account for half of the global numbers and the five-year survival rate for patients with HCC in China is only 14%.

Tislelizumab was approved by the NMPA as a treatment for nine indications, including conditional approval ‘for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy’.

Additional tislelizumab’s sBLAs under review at the CDE include: combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1; combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Tislelizumab is not approved for use outside of China. Ex-China rights have been licensing to Swiss pharma giant Novartis, as part of a 2021 deal worth up to around $2 billion.