China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by deletion of Exon 19 or a L858R mutation in Exon 21 of the EGFR gene.
Strategic Licensing Partnership Enhances Development Pathway
In December 2018, Betta Pharmaceuticals entered into a pivotal licensing agreement with InventisBio (SHSE: 688382), securing exclusive rights for the development and commercialization of befotertinib (D0316) across mainland China, Hong Kong, and Taiwan. This partnership has accelerated the drug’s trajectory within a competitive oncology landscape. Notably, befotertinib was first approved in China in May for treating locally advanced or metastatic NSCLC with the EGFR T790M mutation after disease progression post-EGFR-TKI therapy.
Navigating Reimbursement Landscape for Enhanced Accessibility
Befotertinib has also successfully passed the preliminary review for the National Reimbursement Drug List (NRDL), a significant step that may streamline patient access to this innovative therapy within the upcoming update. The NMPA’s approval and potential inclusion in the NRDL underline Betta Pharma’s commitment to advancing treatments for NSCLC and improving outcomes for patients.-Fineline Info & Tech
