On March 10, 2021, Akeso, Inc. (9926.HK) announced that its commercialization manufacturing base, located in Guangzhou Zhongxin Knowledge City, project phase I officially went into production, adding manufacturing capacity of up to 20,000L to Akesobio. With an overall investment of over two billion RMB, the project can house up to 40,000L manufacturing capacity in total. This is also the second commercialized manufacturing base of Akesobio, marking the company’s industrialized production capacity boosting to a new level.
The base will be responsible for the commercialized production of a series of products, including Akesobio’s first-in-class blockbuster novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, AK104). Currently Cadonilimab is in clinical trials simultaneously in the United States and China. In Dec. 2020, patient screening for enrollment was completed in advance in a registrational clinical trial for Cadonilimab, which is designated for treating patients suffering from recurrent or metastatic cervical cancer in China. In Feb. 2021, Cadonilimab obtained orphan drug designation from the FDA for treating cervical cancer (except very early stage IA1).
Speaking at the commissioning ceremony, Michelle Xia, PhD, President & CEO of Akesobio, said that among Akesobio’s R&D pipelines, over 20 have reached clinical trial phase II or further stage. Our R&D innovation has ushered in harvest time. As the products and indication getting approved, it has become Akesobio’s important strategy to build an advanced, scaled and industrialized production system, therefore accelerating commercialization of hi-tech achievements.