China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has progressed following EGFR-TKI treatment.
Partnership and Licensing Deal with InventisBio
Betta Pharma struck a licensing deal with compatriot firm InventisBio (SHA: 688382) in December 2018, obtaining exclusive development and commercialization rights to befotertinib (D0316) in mainland China, Hong Kong, and Taiwan. Clinical studies for the drug in locally advanced or metastatic NSCLC with the T790M mutation following resistance to EGFR-TKI demonstrated an objective response rate (ORR) of 67.6%, a disease control rate (DCR) of 94.8%, a median preogression-free survival (PFS) of 16.6 months, and a median duration of response (DOR) of 18.0 months. Research indicates that befotertinib is comparable to similar drugs in terms of key efficacy indicators such as ORR and intracranial efficacy.
Market Competition with Other Third-Generation EGFR-TKIs
AstraZeneca’s Tagrisso (osimertinib), Hansoh Pharma’s almonertinib, and Allist Pharma’s furmonertinib are all third-generation EGFR-TKIs that are commercially available in China and included in the National Reimbursement Drug List (NRDL). The approval of befotertinib adds to the competitive landscape of targeted therapies for patients with EGFR-mutated NSCLC in China.-Fineline Info & Tech
