BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (sBLA) for its PD-1 inhibitor tislelizumab, seeking approval for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This marks the 11th market filing for tislelizumab in China.
Drug Profile
Tislelizumab has nine approved indications in China, including:
- Combined with chemotherapy for first-line advanced squamous (sq) and non-squamous (nsq) non-small cell lung cancer (NSCLC).
- Monotherapy for second- or third-line NSCLC.
- Conditional approvals for classical Hodgkin’s lymphoma (cHL), metastatic urothelial carcinoma (UC), hepatocellular carcinoma (HCC), MSI-H/dMMR solid tumors, second-line ESCC, and recurrent/metastatic nasopharyngeal carcinoma (NPC).
- In June 2022, the drug was filed for first-line gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with PD-L1 expression.-Fineline Info & Tech
