China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that its clinical trial filing for BPI-D0316, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been accepted for review by the National Medical Products Administration (NMPA). The filing is for the drug’s use as a postoperative adjuvant therapy for IB-IIIB (T3N2M0) stage non-small cell lung cancer (NSCLC) with EGFR sensitive mutation.
BPI-D0316 Profile
BPI-D0316 is currently awaiting regulatory decisions in China for its use in locally advanced or metastatic NSCLC with T790M mutation after previous use of EGFR-TKI. The drug has concluded a Phase II/III clinical study as a first-line treatment for naïve locally advanced or metastatic NSCLC with EGFR sensitive mutation. As of the announcement date, AstraZeneca’s Tagrisso (osimertinib) is the only third-generation EGFR-TKI approved in China for postoperative adjuvant therapy.
Future Implications
The acceptance of the clinical trial filing for BPI-D0316 marks a significant step for Betta Pharmaceuticals in expanding its presence in the NSCLC treatment market. This move positions the company to offer a new therapeutic option for patients with EGFR-mutated NSCLC, potentially enhancing postoperative outcomes and addressing significant unmet medical needs.-Fineline Info & Tech
