New Drug Application for Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody) for the Treatment of Relapsed or Metastatic Cervical Cancer Accepted by NMPA

HONG KONG, Sept. 24, 2021 /PRNewswire/ -- Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) for the treatment of relapsed or metastatic cervical cancer, which has received priority review. Cadonilimab, independently developed and manufactured by the Company, is the first PD-1 based bi- specific antibody drug in the world to submit new drug application.

Director of Oncology and Gynecology, Fudan University Cancer Hospital, Prof. Wu Xiaohua said, "Although PD-1 monoclonal antibody for the treatment of cervical cancer indication has been approved for global market launch, but the clinical study results show that it only achieves an objective response rate of not more than 15% in second-line or more PD-L1 positive patients. The efficacy and safety data of Cadonilimab as monotherapy shown in the phase II pivotal clinical trial are encouraging. Not only does it achieve a high response rate among PD-L1 positive population, it also shows good effect in PD-L1 negative population, with a significant improvement in the median progression-free survival, offering better treatment for patients with advanced cervical cancer in China."

Founder, president & CEO of Akeso, Inc., Dr. Xia Yu said, "Cadonilimab is developed by scientists at Akeso with years of dedication. It is a bi-specific antibody new drug with global patent that targets simultaneously PD-1/CTLA-4 and also the first PD-1 based bi-specific antibody drug in the world to submit new drug application. We much appreciate the excellent efforts from the Akeso team, clinical research center, medical experts and departments of drug administration at all levels for this. The Company will dedicate its leading advantages in the field of bi-specific antibodies, accelerate the clinical research of Cadonilimab in other indications. We are looking forward to the advantages of Cadonilimab in the immuno-oncology therapy to benefit more oncology patients.