On 26 Sept 2021, Akeso, Inc. (9926.HK) (the “Company” or “Akeso”) was included in the “Chinese Antibody Drug Companies Innovation TOP 30” list at the “2020 Chinese Biopharma Companies Innovation TOP 100 Series Lists” organized by MENET.
The innovation evaluation index of this series were grouped into four dimensions, including “innovation input”, “innovation achievements”, “intellectual property”, “innovation drive”, with 11 index systems. Innovative drug companies were evaluated comprehensively based on public data from companys’ annual reports, CDE assessment data, third-party patent statistics agencies, MENET database, etc.
Meanwhile, Akeso was also ranked TOP 10 in the “2021 Chinese Biopharmaceuticals Research and Development Ability Ranking TOP 50” published by the 2021 Conference on High Quality Development of Healthcare Industry on 18 Sep 2021, demonstrating the Company’s research and development (R&D) ability highly acknowledged by the industry.
It has been Akeso’s development strategy since inception to internationally and independently innovate, research and develop. With years of R&D endeavor, the Company has established one of the richest and fastest-growing innovative antibody drug pipelines in China. Over 20 innovative drug pipelines were developed, including 6 bispecific antibodies such as Cadonilimab (AK104, PD-1/CTLA-4), AK112 (PD-1/VEGF), AK131 (PD-1/CD73), AK129 (PD-1/LAG3), etc. A total of 13 innovative drugs are in clinical development stage.
Currently, Akeso’s innovative R&D pipeline has entered a rewarding stage.
In September 2021, the new drug application (NDA) of the Company’s globally first-in-class PD-1/CTLA-4 bispecific antibody drug, Cadonilimab (AK104), for treatment of relapsed or metastatic cervical cancer, was accepted by the National Medical Products Administration (NMPA) of China. It has also received priority review, and has entered the approval assessment stage. Cadonilimab has become the world’s first PD-1 based bispecific antibody to successfully submit the NDA. Clinical trials of other major indications that Cadonilimab has planned for are simultaneously in progress, including gastric cancer, lung cancer, liver cancer, esophageal squamous cancer, nasopharyngeal cancer, etc. Among which the phase III clinical trial of Cadonilimab for first-line treatment of gastric cancer has also officially initiated.
At the same time, the Company’s another world-leading PD-1/VEGF bispecific antibody, AK112, has multiple registrational/phase III clinical trials that are in preparation or have already been initiated, with indications including lung cancer, gynecological tumors, liver cancer, gastric cancer, solid tumors, breast cancer, etc. AK112 is the Company’s another innovative bispecific antibody drug to enter late-stage clinical trial after Cadonilimab.
Previously in August, the Company’s independently and self-developed differentiated new PD-1 monoclonal antibody, Penpulimab injection (安尼可®), has received approval from the NMPA for market launch. The market launch of this drug marks the completion of Akeso’s closed-loop industry chain from R&D to manufacture and to commercialization.
Furthermore, as of the first half of 2021, another 3 drugs (indications) of the Company have submitted new drug application in China and in the U.S., 2 clinical researches reached key endpoints and 6 clinical researches advanced to registrational/phase III clinical trial stage.
In the future, the Company will advance innovative drug clinical trials and pre-clinical plan with higher efficiency to further enrich our product portfolio in immuno-oncology and other immunotherapy areas. The Company will also focus on the research of key drugs and key indications to accelerate the product pipelines’ commercialization.