BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by the National Medical Products Administration (NMPA) on mainland China.
Indications Covered by Approvals
The approvals cover a range of cancers, including classical Hodgkin’s lymphoma, urothelium carcinoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma, highly microsatellite unstable solid tumor, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. Notably, the first-line therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) tumors with overexpressed PD-L1 has not yet been approved in the region.
Tislelizumab’s Indication Approvals and Reimbursement in China
Tislelizumab has obtained 10 indication approvals in China, with 9 of them covered by the National Reimbursement Drug List (NRDL). The drug is currently under review for first-line treatment of advanced esophageal squamous cell carcinoma combined with chemotherapy and for first-line treatment of unresectable or metastatic liver cancer patients.
Tislelizumab’s Previously Approved Indications in China
Tislelizumab’s previously approved ten indications in China include third-line classical Hodgkin’s lymphoma (cHL), metastatic urothelial carcinoma (UC), first-line squamous non-small cell lung cancer (sqNSCLC) combined with chemotherapy, second-line therapy for hepatocellular carcinoma (HCC), first-line non-squamous non-small cell lung cancer (nsqNSCLC), second or third-line treatment of NSCLC, unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, second-line for esophageal squamous cell carcinoma (ESCC), first-line therapy for nasopharyngeal carcinoma (NPC), and first-line therapy for G/GEJ combined with chemotherapy plus fluorouracil.-Fineline Info & Tech
