On Jul. 13, 2020, Lonza and Junshi Biosciences announced that the first healthy volunteer had been dosed in a Phase I clinical study of JS016 at Huashan Hospital affiliated to Fudan University in China in Jun.. JS016 was the first SARS-CoV-2 neutralizing antibody that had entered clinical trials in China and was produced using Lonzaﾒs GS Xceed Expression System. This follows on from a successful launch of the first PD-1-targeting antibody using GS Xceed last year.

At the start of the COVID-19 outbreak, Junshi Biosciences rapidly launched the research and development program focused on neutralizing antibodies using Lonza’s GS Xceed expression system. Within two months, the company had completed IND enabling preclinical studies, process development and production for GLP toxicity studies, as well as the GMP production of clinical material. Junshi Biosciences is collaborating with Eli Lilly and Company to co-develop JS016 globally, with Junshi leading clinical development in Greater China and Lilly leading clinical development in the rest of the world.

The GS Xceed Expression System is Lonza’s market-leading expression technology platform that includes host cell lines, vectors, and access to optimized media and feeds, as well as comprehensive methods and processes. This robust, fully integrated, scalable system can express a diverse range of biologic drugs and has an unparalleled track record of successfully taking programs from gene through cell line construction to commercial products. Together with the technical and regulatory expertise, this expression system is expected to provide valuable support for the JS016 program by helping to improve cell line development timelines and improving yields.