By Fineline Cube 
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that its Category 1 small molecule targeted drug, furmonertinib, has been granted priority review status by China’s Center for Drug Evaluation (CDE). The drug is being evaluated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with EGFR exon 20 insertion mutations (exon20ins) who have progressed on or are intolerant to platinum-based chemotherapy.
Furmonertinib’s Clinical Progress
Previously, furmonertinib had already received Breakthrough Therapy Designation (BTD) from the CDE for its second-line treatment of EGFR exon20ins NSCLC. The drug represents a significant advancement in the treatment landscape for this specific patient population, offering new hope where limited options previously existed.
Drug Profile and Development
Furmonertinib is an internally discovered, irreversible, selective third-generation EGFR tyrosine-kinase inhibitor. Allist is co-developing the drug in territories outside of Greater China with ArriVent under a 2021 agreement. The drug was first approved in China in March 2021 for treating patients with locally advanced or metastatic NSCLC that is EGFR T790M mutation-positive and has progressed following treatment with an earlier generation EGFR-targeted TKI. It subsequently received approval for use in first-line locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation in June 2022. Both indications are covered by the National Reimbursement Drug List (NRDL).-Fineline Info & Tech