#China #Hong Kong #Akeso #Penpulimab #NPC

Akeso's Penpulimab Achieves NMPA Approval

On March 16, 2025, Akeso Inc. (9926.HK) celebrated a significant breakthrough in cancer treatment with the National Medical Products Administration's (NMPA) approval of Penpulimab, a self-developed anti-PD-1 monoclonal antibody, as a first-line therapy for recurrent or metastatic nasopharyngeal cancer (NPC) when used alongside chemotherapy. This approval expands its previous use as a third-line treatment, offering a more comprehensive immunotherapy option for patients across various stages of NPC.

Overview of Penpulimab

Penpulimab stands out as a unique IgG1 subtype anti-PD-1 monoclonal antibody globally. Its mechanism of action enhances the immune response against cancer cells, providing a robust treatment option. This latest approval marks the fourth indication for the drug, further establishing its importance in oncology. Alongside NPC, Penpulimab is also indicated for first-line treatment in locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) and as a monotherapy for patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Clinical Significance

Professor Hu Chaosu, a key researcher from Fudan University Shanghai Cancer Center, emphasized the critical role of Penpulimab in addressing the unmet clinical needs in China for NPC treatments. He noted that this approval is a milestone that broadens the treatment landscape for NPC patients, ensuring they have access to continuous immunotherapy throughout their treatment journey.

NPC is especially prevalent in certain regions, bearing a grim prognosis for those with recurrent or metastatic cases. Professor Chen Xiaozhong from Zhejiang Cancer Hospital highlighted the significant survival benefits and high response rates observed in clinical trials, thereby reassuring the medical community about Penpulimab's efficacy and safety profile.

Acknowledgments and Future Directions

Dr. Xia Yu, the esteemed founder and CEO of Akeso, extended heartfelt gratitude to all those involved in the clinical trials and research efforts for Penpulimab. The drug's bar-raising design and positive outcomes have earned it significant recognition among healthcare professionals, leading to hopes that the availability of this treatment will markedly improve recovery rates for NPC patients in China.

Akeso's commitment to innovation is underpinned by its extensive pipeline of therapies, including other antibodies like cadonilimab and ivonescimab. With the expansion of Penpulimab’s approvals, the company reinforces its dedication to not only improving patient outcomes but also transforming global healthcare by introducing groundbreaking therapies.

Moving forward, Akeso aims to lead advancements in oncology, setting new standards for cancer care while positively impacting the lives of patients worldwide. The company continues to pursue further approvals, including a supplemental New Drug Application (sNDA) for Penpulimab in combination with anlotinib for advanced hepatocellular carcinoma (HCC).

Conclusion

The NMPA's approval of Akeso's Penpulimab for NPC is a promising development in the treatment of this challenging cancer, marking a pivotal point for both clinicians and patients navigating their health journey. As Akeso forges ahead with its innovative drug developments, it holds the potential to contribute significantly to enhanced therapeutic options in oncology.