{"id":20016,"date":"2023-04-06T22:01:00","date_gmt":"2023-04-06T14:01:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20016"},"modified":"2024-12-27T22:04:07","modified_gmt":"2024-12-27T14:04:07","slug":"allist-pharmaceuticals-furmonertinib-receives-nmpa-approval-for-two-clinical-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20016","title":{"rendered":"Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials"},"content":{"rendered":"\n

Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578<\/a>) 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.<\/p>\n\n\n\n

Co-Development with ArriVent Biopharma and Global Trials<\/strong>
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.<\/p>\n\n\n\n

Furmonertinib’s Market Approval and Reimbursement Status<\/strong>
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<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai-based Allist Pharmaceuticals Inc. 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