On April 26, 2021, Akeso, Inc. (9926.HK) signed cooperation agreement with Cytiva, the two sides will join hands again to build the new intelligent production workshop at the Akeso Sino-Singapore Guangzhou Knowledge City biopharmaceutical base, which will make Akeso owner of the biggest FlexFactory platform in the world. Currently Akeso has over 80,000 L production capacity in plan under construction. As its products are gradually commercialized, Akeso’s production capacity expects further orderly expansion.
With pipeline researches rapidly advancing, Akeso’s research and development innovation has gradually entered “harvest time”. In 2021, Penpulimab (PD-1 monoclonal antibody) expects to be approved shortly. There are 3 more NDA to be submitted this year, including the first-in-class PD-1/CTLA-4 bispecific antibody drug Cadonilimab for treatment of advanced cervical cancer, etc. In this context, scientifically and orderly increasing the industrialization capacity is crucial to guarantee the commercialization progress of Akeso’s many innovative drugs.
At the “Akeso Guangzhou FlexFactory intelligent manufacturing base” signing ceremony, Guangzhou municipal and Huangpu district government officials, together with senior management representatives of Akeso and Cytiva attended the event.
Since the establishment in 2012, Akeso has grown into the leader of biopharmaceutical industry in China with its strong research and development innovation capability and system. Akeso has developed over 20 innovative antibody drugs, including 6 bispecific antibody novel drugs. Currently over 40 clinical trials are efficiently advancing globally at Akeso, among which 9 researches are at registrational or phase III stage, four registrational clinical researches have reached key endpoints and are about to submit NDA. Especially the first new drug Penpulimab has submitted NDA in 2020, which is expected to be approved in the near future to benefit numerous patients; the globally first-in-class PD-1/CTLA-4 bispecific antibody drug Cadonilimab, is expected to submit NDA in 2021 and become the world’s first PD-1 based bispecific antibody drug, leading the immuno-oncology era 2.0.
To match the drug research and development progress and to fulfill the need of rich pipelines’ advancement and new drug commercialization, Akeso has been scientifically and orderly enhancing its industrialized system capability in recent years.
Since 2016, Akeso has been establishing its quality innovative drug commercialization system in cooperation with Cytiva. Now Akeso already possesses sophisticated drug commercialized production capability and experience. By the end of 2020, Akeso’s 13 innovative drugs are in over 40 clinical trials globally, numerous patients have been dosed with over 130,000 vials of innovative antibody drug, all come from Akeso’s own production line.
In cooperation with Cytiva again, the production capacity of Akeso Sino-Singapore Guangzhou Knowledge City biopharmaceutical base will be further expanded. Total investment of this base exceeds 2 billion, with a planned production capacity of 60,000 L, among which the 20,000 L of Akeso project phase I has gone into operation for the production of the globally first-in-class PD-1/CTLA-4 bispecific antibody drug.
Founder, president & CEO of Akeso, Dr. Xia Yu said in her speech:
Akeso’s rich innovative drug research and development pipelines have entered harvest time, as the novel drugs are in process of NDA approval, in order to speed up the commercial transformation of scientific achievements, as well as providing quality innovative drugs to patients and support Akeso’s international development, it is Akeso’s important strategic measures to establish large-scale commercialized manufacturing system in accordance with the requirements of the NMPA (China), the FDA (the U.S.) and the EMA.
General manager of Cytiva Greater China, Ms. Yu Lihua said:
As Akeso’s loyal cooperative partner, Cytiva has been growing along with Akeso for the past ten years. Relying on the process development experience and leading FlexFactory platform, we enable comprehensive innovative drug research, development and commercial manufacturing, help Akeso to promote the speed, efficiency and capability in research, development and manufacturing process.
“It is Akeso’s mission as China’s antibody drug innovation pioneer and practitioner to promote and even to lead the innovation and development of Chinese biopharmaceutical industry. Akeso is determined to become important carrier of the pharmaceutical and health industry domestic cycle, actively connect and promote the domestic and international ‘dual circulation’.” Dr. Xia Yu further pointed out at the event that, Akeso Sino-Singapore Guangzhou Knowledge City biopharmaceutical base carries Akeso’s expectation of the company, the industry, the Guangdong-Hong Kong-Macao Greater Bay Area and the future. Together with Cytiva, we hope to further promote Akeso’s growth in industrialization capability and make contribution to the development of pharmaceutical and health industry in the Guangdong-Hong Kong-Macao Greater Bay Area.