Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its drug furmonertinib. The drug is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutation or EGFR L861Q mutation. Furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor, has previously been approved for the treatment of exon 20 insertion mutated NSCLC and advanced NSCLC with EGFR or HER2 mutations.
Co-Development Partnership with ArriVent Biopharma
Discovered in-house by Allist Pharmaceuticals, furmonertinib is co-developed with US-based ArriVent Biopharma for markets outside of Greater China, following a deal established in 2021. The drug is classified as a Category 1 innovative product, reflecting its novel status in the treatment landscape.
Furmonertinib’s Market Approval History and Reimbursement
Furmonertinib 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 tyrosine kinase inhibitor (TKI). The drug later obtained marketing approval for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. Furmonertinib is included in the National Reimbursement Drug List (NRDL), with both second and first-line indications covered, ensuring broader access to this treatment for patients.-Fineline Info & Tech
