NMPA Approves Akeso's Penpulimab for First-Line Nasopharyngeal Cancer Treatment

HONG KONG, March 16, 2025 – Akeso Inc. has announced that its innovative anti-PD-1 monoclonal antibody, penpulimab, has received official approval from the National Medical Products Administration (NMPA) for use as a first-line treatment for recurrent or metastatic nasopharyngeal cancer (NPC) when used in combination with chemotherapy. This development marks a significant step forward in the treatment landscape for NPC patients.

Penpulimab was previously approved for use as a third-line treatment for advanced NPC. With this latest approval, it now offers a comprehensive treatment option for patients across all stages of NPC, providing continuous immunotherapy from first-line to third-line treatment. This expansion of treatment stages marks the fourth indication for penpulimab. Besides its newly approved application for NPC, penpulimab is also authorized for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, and as a monotherapy for patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have undergone at least two lines of systemic chemotherapy. In addition, a supplemental New Drug Application (sNDA) is under review for penpulimab, when combined with anlotinib, for the first-line treatment of advanced hepatocellular carcinoma (HCC).

Professor Hu Chaosu from Fudan University Shanghai Cancer Center, a principal investigator in the development of penpulimab, emphasized the significant unmet clinical need for NPC in China. He noted that penpulimab, as the only IgG1 subtype anti-PD-1 monoclonal antibody globally, has shown robust efficacy in clinical studies. This approval represents a major milestone, offering a comprehensive treatment regimen for both clinicians and patients, significantly benefiting numerous NPC patients from the initial to advanced stages of therapy.

Professor Chen Xiaozhong from Zhejiang Cancer Hospital, another principal investigator, highlighted the high prevalence and poor prognosis typically associated with recurrent or metastatic NPC. He pointed out that penpulimab has achieved a notably high response rate and extended survival benefits for patients, both in first-line treatment scenarios and for those with metastatic NPC who have failed multiple prior therapies. The drug has also demonstrated a favorable safety profile with a low incidence of immune-related adverse events.

Dr. Xia Yu, the Founder, Chairwoman, CEO, and President of Akeso, expressed gratitude to the researchers, clinical trial participants, and NPC patients for their contributions to this milestone. She remarked on penpulimab’s differentiated design and recognition among clinicians and patients for its efficacy and safety in treating diseases such as non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for its use in first-line treatment of advanced NPC will enable more patients in China to benefit from this novel PD-1 monoclonal antibody, enhancing survival outcomes.

The approval of key drugs such as cadonilimab, ivonescimab, and penpulimab for various indications highlights Akeso's commitment to innovation and excellence in drug development, from discovery through clinical application. These advancements are not only improving patient outcomes but also reaffirming Akeso's dedication to transforming global healthcare. The company continues to pioneer breakthrough therapies with the potential to set new standards of care, driving positive changes in treatment paradigms and enhancing the lives of patients worldwide.