Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated non-small cell lung cancer (NSCLC) and separately for advanced NSCLC with EGFR or HER2 mutations.
Co-Development with ArriVent Biopharma and Global Trials
Discovered in-house by Allist, furmonertinib is co-developed in territories outside of Greater China with US-based ArriVent Biopharma under a deal signed in 2021. The two trials include the Phase III FURMO-004 study, which focuses on NSCLC patients with exon 20 insertion mutations and has been approved in the United States, France, and Japan; and the Phase Ib FURMO-002 study, assessing the molecule in EGFR/HER2 mutated NSCLC. Both studies are already underway in multiple countries outside China, including the United States, Spain, Australia, and Japan.
Furmonertinib’s Market Approval and Reimbursement Status
Furmonertinib, a Category 1 innovative product, first received conditional market approval from the NMPA in March 2021 for use in locally advanced or metastatic NSCLC that is EGFR T790M mutation-positive and has progressed following treatment with an earlier generation EGFR-targeted TKI. The drug is included on the National Reimbursement Drug List (NRDL), with both second and first-line indications covered, making it accessible to a wider patient population in China.-Fineline Info & Tech
