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

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.

Cadonilimab is the second innovative antibody drug of the Company to submit the new drug application and the fifth new drug application submitted by the Company in China and in the United States.

The clinical trial data has shown that Cadonilimab has favorable efficacy and safety profile for the treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy. Among the target indication population, Cadonilimab has shown better efficacy compared to the published data of PD-1 monoclonal antibody on the market. Relevant clinical data will be published in relevant international conferences and medical journals.

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. 2030 is the critical year for both initiatives ''Global Strategy to Accelerate the Elimination of Cervical Cancer'' and ''Healthy China 2030''. The Company believes that as the first self-developed bi-specific antibody drug in China, Cadonilimab will facilitate the smooth implementation of the global cervical cancer initiative and the health strategy of China as mentioned above."

Chairman-designate of Chinese Medical Association Gynecological Oncology Branch, Prof. Kong Beihua from the Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, said, "Cervical cancer has the highest incidence among gynecological malignancies in China, and patients with advanced recurrent metastatic cervical cancer are refractory to routine treatment. This represents one of the biggest challenges faced by gynecologic oncologists with significant clinical needs. The clinical efficacy of immune checkpoint inhibitors as monotherapy is not satisfactory. Despite the potential improvement in efficacy in combination with other treatments, its clinical application is greatly restricted due to severe toxic side effects. The clinical trials of Cadonilimab have demonstrated high efficacy, low susceptibility to toxic side effects as well as safe and controllable results to patients with advanced recurrent metastatic cervical cancer who have failed routine treatment. Cadonilimab has already entered the fast track designation process, this is good news for both doctors and patients, which will lead China's oncotherapy to enter immunotherapy new era ahead of the world, as well as improve the prevention and treatment of cervical cancer in China, benefiting the patients and making good cause for celebration."

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.

Milestones of Cadonilimab for treatment of cervical cancer:

July 2021, the phase III clinical trial of Cadonilimab in combination with chemotherapy for treatment of advanced cervical cancer officially initiated.

Feb 2021, the Food and Drug Administration of the United States (the FDA) granted orphan drug designation to Cadonilimab for treatment of cervical cancer.

Oct 2020, Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy was included in the list of "Breakthrough Therapy Designation" by the Center for Drug Evaluation (the CDE) under the NMPA.

July 2020, the FDA granted fast track designation to Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy.

Currently major indications of Cadonilimab include gastric cancer, lung cancer, liver cancer, esophageal squamous cancer, nasopharyngeal cancer, etc. Among which the phase III clinical trial for first-line treatment of gastric cancer has officially initiated.

About Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.

Information about Akeso, Inc.

Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable   to patients worldwide. Since the Company's establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company's first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection was approved to the market. The Company's vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.

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Source: Akeso, Inc.