Akeso is committed to establishing an excellent production facility system that meets international good manufacturing practice (GMP) standards.
Akeso’s GMP-compliant manufacturing facilities are designed and validated according to the NMPA, the FDA and the EMA regulations, and support the entire drug development process, from drug discovery to process development, GMP-compliant pilots and commercial manufacturing. Meanwhile, we conduct daily process audits and comprehensive annual audits of our production facilities to assess compliance with GMP and related quality standards.
At present, Akeso has planned a production layout in Zhongshan, Guangzhou, etc. with a planned total capacity of more than 160,000L. Upon completion, Akeso will become the biopharmaceutical enterprise with the largest intelligent production system in China.
National Health Technology Park, the first biopharmaceutical manufacturing facility in the Greater Bay Area to begin using the GE Healthcare's FlexFactory™ platform with a centralized control system, boasts a production capacity of 3,000 L. Equipped with advanced technologies, the facility enables the production of clinical-stage drugs and seamless transitions between multiple drug candidates, accelerating Akeso's antibody projects into global trials and commercialization. Currently, the Park is undergoing an upgrade to establish a highly efficient antibody-drug conjugate (ADC) production facility, empowering Akeso's new platform development with seamless R&D and manufacturing integration.
As a key project of Guangzhou based on international first-class design concepts, the Sino-Singapore Guangzhou Knowledge City Biopharmaceutical Base is planned to become a demonstration base for local biomedical innovation enterprises in Guangdong. It meets the GMP requirements of FDA, EMA and NMPA for the production of biopharmaceuticals, with a total investment of over RMB 3 billion and the commenced operation with production capacity of 36,000L. It is composed of three parts: Akeso Pharma Co., Ltd (Akeso Pharma), AD Pharmaceuticals (AD Pharma) and Akeso Longyue. Akeso Pharma is equipped with a complete set of Cytiva FlexFactoryTM drug production equipment, a BOSCH automatic preparation filling line, etc., with a planned total capacity of 60,000L. The commenced operation with production capacity of 20,000L in March 2021, and it is mainly used for large-scale production of self-developed new biologics including开坦尼®(Cadonilimab injection). AD Pharmaceuticals has been put into production with a total capacity up to 16,000L, mainly used for the large-scale production of innovative monoclonal antibody drugs 伊喜宁® (Ebronucimab injection) and Pulocimab independently developed by the Company,and Ebronucimab has been granted marketing approval by the NMPA of China in September 2024. Akeso Longyue is also meticulously being constructed in alignment with international standards, and will soon be completed in 2025.
Akeso Greater Bay Area Technology Park integrates research, development, production, and commercialization of biopharmaceuticals. It is a pioneering, "digitalized" biopharmaceutical innovation and manufacturing complex, strategically aligned with China's "Made in China 2025" initiative and international Industry 4.0 standards. The Park spans a land area of 167 mu (approx. 11.1 Ha) with a construction area of 440,000 m². With a total investment of CNY 2.5 billion and a planned production capacity exceeding 100,000 L, it is set to become one of China’s largest biopharmaceutical production bases. The Akeso Greater Bay Area Technology Park became fully operational in March 2024.
The Park has built a highly automated intelligent factory equipped with the most cutting-edge international facilities. Among them, the stainless steel production line comprises 4 Zeta Austrian 10,000L stainless steel reactors alongside essential upstream and downstream equipment, meticulously designed to fulfill the highest global standards regarding process requirements.Both the 40,000-liter stainless steel bioreactor production line and the 12,000-liter disposable production line utilize the internationally advanced DCS+Batch discrete control system, enabling a one-click production mode for the entire line's large-scale formulations. With a single start-up, the entire process operates automatically with intelligence and visibility, significantly reducing human operational deviations and the modular hygienic design exceeds international standards.The entire GMP equipment line achieves 100% data capture, analysis, and archiving in real-time during the production process, facilitating audit tracking. Additionally, it enables the identification and refinement of "golden batches", ensuring continuous improvement in drug quality and realizing genuine quality improvement, cost reduction, and efficiency enhancement.
The Akeso Greater Bay Area Technology Park will drive Akeso Biopharma to independent development, globally leading innovative drugs, benefiting patients worldwide. It will effectively drive the formation and development of upstream and downstream industrial clusters, promote high-quality development of the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area and Zhongshan, and contribute innovative strength to the advancement of biopharmaceuticals in China and globally.
Akeso Global innovation Center is situated in the Zhangjiang Headquarters Park (Youchuang Park) in Shanghai, spanning an expansive 14,000 m2 area and boasting a total construction space of 67,000 m2. With an anticipated total investment of CNY850 million, the construction is already underway. Functioning as a pivotal element in Akeso's global innovation strategy and serving as the primary driver for sustained high-speed innovation and development in the future, the Akeso Global R&D Center aligns strategically with the group's research and development objectives. Its aim is to grasp and lead the latest global research directions, with a specific focus on cutting-edge technological fields such as gene therapy, cell therapy, neurodegenerative diseases, anti-aging, and more. The center will consistently build an advanced research pipeline and establish platforms and teams for tumor microenvironment big data analysis and translational research.Using Zhangjiang as a gateway, Akeso Global innovation Center will connect with global resources, support the establishment of a world-class biopharmaceutical industry cluster in Zhangjiang, Shanghai, and drive the global expansion of innovative drugs developed in China, ultimately benefiting patients in China and across the globe.
International Clinical Research and Development Center and Translational Medicine Center will be built in the Akeso Clinical Research and Operation Asia Pacific Center. The Clinical Research and Development Center will set up National Clinical Data Center, Clinical Operations, Clinical Research, Clinical Medicine, Clinical Audit and Clinical Quality Center. The Translational Medicine Center will build Preclinical Translational Lab, and Clinical Sample Testing Lab, etc. With the establishment of the base, a more systematic and advanced comprehensive R&D center will be created.
