Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1) inhibitor, penpulimab (AK105), seeking approval for its use in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy. The application is currently under review by China’s Center for Drug Evaluation (CDE).
Penpulimab was initially approved in August 2021 as a third-line treatment for relapsed/refractory classic Hodgkin lymphoma (cHL). In January 2023, it received approval for first-line use in locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) in conjunction with chemotherapy. A regulatory decision is also pending for its application in the third-line setting for recurrent/metastatic NPC in China.
In December 2021, Akeso formed a 50-50 joint venture with Chia Tai Tianqing, granting exclusive marketing rights for penpulimab in China. Additionally, in April this year, Singapore-based Specialised Therapeutics Asia Pte Ltd secured an exclusive marketing license for penpulimab in Australia, Singapore, and Southeast Asia.- Flcube.com
