By Fineline Cube 
China-based Akeso, Inc. (HKG: 9926) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its PD-1 monoclonal antibody (mAb) penpulimab. The drug is approved for use in combination with cisplatin or carboplatin and gemcitabine for first-line treatment of adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). Additionally, the FDA approved penpulimab as a monotherapy for adults with metastatic non-keratinizing NPC who have experienced disease progression following platinum-based chemotherapy and at least one other prior therapy.
Clinical Trial Support
The FDA’s decision is supported by positive results from the Phase III AK105-304 and AK105-202 studies. Penpulimab has received breakthrough therapy designation, orphan drug designation, and fast track designation from the FDA, underscoring its potential in addressing unmet medical needs in NPC treatment.
Development and Commercialization
Penpulimab, a differentiated PD-1 mAb independently developed by Akeso, is further developed and commercialized through a joint venture with Chia Tai-Tianqing Pharmaceutical Group. In China, the drug is approved for first-line and second or later line treatment of advanced NPC. This FDA approval marks a significant milestone in the global expansion of Akeso’s oncology portfolio.-Fineline Info & Tech