HONG KONG,March 17,2025 --Akeso Inc. (9926.HK) announced that its innovative,self-developed anti-PD-1 monoclonal antibody,penpulimab,has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy.

Previously,penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval,penpulimab now provides comprehensive treatment coverage across all stages of NPC,offering patients a continuous immunotherapy option from first-line to third-line therapy.

This marks the fourth approved indication for penpulimab. In addition to the two NPC indications,penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy,as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore,a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review.

Professor Hu Chaosu,one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center,said: "In China,there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally,penpulimab has demonstrated robust efficacy in clinical studies,enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone,as it provides a comprehensive treatment regimen for clinicians and patients,benefiting a large population of NPC patients in China,from first-line to third-line therapy."

Professor Chen Xiaozhong,one of the principal investigators of penpulimab at Zhejiang Cancer Hospital,said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions,and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally,it has shown a favorable safety profile,with a low incidence of immune-related adverse events. "

Dr. Xia Yu,Founder,Chairwoman,CEO,and President of Akeso,said: "We want to extend our sincere gratitude to all the researchers,clinical trial participants,and NPC patients who have contributed to this milestone. With its differentiated design,penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC),Hodgkin lymphoma,and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody,further improving survival outcomes."

"As key drugs like cadonilimab,ivonescimab,and penpulimab receive approval for a wide range of indications,Akeso's commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward,Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care,driving positive change in treatment paradigms and improving the lives of patients worldwide."