{"id":21847,"date":"2025-01-18T13:10:28","date_gmt":"2025-01-18T05:10:28","guid":{"rendered":"https:\/\/flcube.com\/?p=21847"},"modified":"2025-01-18T13:10:30","modified_gmt":"2025-01-18T05:10:30","slug":"aosaikangs-limertinib-approved-for-egfr-t790m-mutated-nsclc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=21847","title":{"rendered":"Aosaikang’s Limertinib Approved for EGFR T790M-Mutated NSCLC"},"content":{"rendered":"\n

Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755<\/a>) has recently received approval from the National Medical Products Administration (NMPA) for the registration and market launch of its drug Limertinib (Brand name: Aoyixing). The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after EGFR-TKI therapy and have been confirmed to have EGFR T790M mutation positivity.<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
In the key Phase IIb clinical study for Limertinib in treating EGFR T790M mutation-positive NSCLC, a total of 301 patients with locally advanced or metastatic NSCLC who had progressed after EGFR-TKI treatment were enrolled. The objective response rate (ORR) assessed by the Independent Review Committee (IRC) was 68.8%, and the disease control rate (DCR) was 92.4%. The median duration of response (DoR) was 11.1 months, and the median progression-free survival (PFS) was 11.0 months. Among patients with assessable central nervous system (CNS) lesions, the best ORR assessed by IRC was 65.9%, with a median PFS of 10.6 months, indicating good efficacy of Limertinib in CNS patients. The safety profile of Limertinib was consistent with previously reported EGFR TKI inhibitors, showing good tolerability.<\/p>\n\n\n\n

Additional Market Application<\/strong>
Furthermore, the Phase III clinical trial of Limertinib versus Gefitinib as first-line treatment for EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC has reached its primary endpoint. A second marketing application for Limertinib was accepted by the NMPA in August 2024 and is currently under review. This application is for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) exon 19 deletions (19DEL) or exon 21 L858R mutations.<\/p>\n\n\n\n

Strategic Implications<\/strong>
The approval of Limertinib by the NMPA is a significant milestone for Aosaikang Pharmaceuticals. It underscores the company’s commitment to advancing innovative treatments for lung cancer and enhancing patient outcomes. By securing approval for this third-generation EGFR TKI, Aosaikang is poised to make a significant impact on the treatment landscape for EGFR T790M-mutated NSCLC, potentially improving the standard of care for patients in China and beyond.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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