Betta Pharma's ensartinib approved for Macau market

Betta Pharmaceuticals (SZSE:300558) announced that the Macao Food and Drug Administration (ISAF) has approved its Ensartinib Hydrochloride Capsules (trade name: Beimeina) for marketing in Macau. The approved indication is for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. Ensartinib is a new-generation ALK inhibitor co-developed with Xcovery Holdings, Inc. and initially approved in China in 2020 for second-line treatment, followed by first-line treatment approval in 2022. The drug is included in the National Medical Insurance Catalogue (2023 Edition) until December 31, 2025. While this approval allows for sales in Macau, Betta Pharma cautions that actual sales figures are subject to market conditions and other variables. Competing ALK inhibitors already available in Macau include crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib. The company advises investors to exercise caution.