#FDA Approval #Hong Kong #Akeso #Penpulimab-kcqx

Akeso's FDA Approval: A New Era for Advanced Nasopharyngeal Carcinoma Treatment

Akeso, Inc. has achieved a historic milestone with the recent FDA approval of its innovative drug, penpulimab-kcqx, for the treatment of advanced nasopharyngeal carcinoma (NPC). This novel PD-1 monoclonal antibody, used in conjunction with either cisplatin or carboplatin and gemcitabine, has been approved for adult patients experiencing recurrent or metastatic NPC. Additionally, the FDA has approved penpulimab-kcqx as a standalone treatment for adults whose NPC has progressed following platinum-based chemotherapy and at least one other treatment line.

This landmark approval not only underscores Akeso's robust clinical research but also signifies the first time the company has penetrated the rigorous United States regulatory landscape. The success of penpulimab-kcqx demonstrates Akeso’s commitment to pushing the boundaries of drug design and development, adhering to international standards in pharmaceutical excellence.

The FDA's decision to approve penpulimab-kcqx is built upon the findings from the international Phase III clinical trials, AK105-304 and AK105-202, which confirmed the drug's effective treatment benefits and favorable safety profile for metastatic NPC. The results from these studies will be showcased at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting, adding to the anticipation surrounding the drug's role in advancing cancer therapy.

In social metrics, NPC is a critical concern, with WHO statistics from 2020 indicating more than 133,000 new cases diagnosed annually worldwide. Approximately 70% of these cases are diagnosed at advanced stages, with recurrent or metastatic NPC presenting a particularly poor prognosis. Thus, the approval of penpulimab-kcqx is expected to provide an essential immunotherapy option for patients struggling with limited survival chances.

Prof. Chaosu Hu from Fudan University, the Principal Investigator for the study of penpulimab-kcqx, remarked, “This pivotal milestone enhances international treatment guidelines and enables the integration of Chinese innovations into global cancer therapy.