- Junshi Biosciences developing therapies for COVID-19 in collaboration with a number of global partners
- Junshi Biosciences' first SARS-CoV-2 neutralizing antibody, expressed using Lonza's GS Xceed® Gene Expression System, entered clinical trials in China
- Track record of the GS Xceed expression system, together with Lonza's technical and regulatory expertise cited as critical enablers for this program
Quote from Jean-Christophe Hyvert, Chief Commercial Officer, Lonza:
“With dozens of commercial products launched using the GS Exceed Gene Expression System, the first clinical trial of neutralizing antibody for COVID-19 in China using our technology is a key milestone for Lonza. Coming off the back of Junshi's approval for the first Chinese anti-PD-1 therapy, Junshi is setting the standard for biologics innovation in China and by choosing GS Xceed they have laid a solid foundation for success.”
Quote from Dr. Feng Hui, Chief Operation Officer of Junshi Biosciences:
“Time to market is critical in this campaign against COVID-19. By leveraging Lonza's GS Xceed Gene Expression System, Junshi launched the first domestic antibody targeting PD-1 (Toripalimab) in China in 2018 and is now successfully advancing JS016, the first-in-class neutralizing antibody targeting SARS-CoV-2 S protein, into clinical stage in China. This powerful GS platform enabled us to fast-track CMC development from stable cell line generation to non-GMP Tox material supply to GMP clinical manufacturing.
Basel, Switzerland, 13 July 2020 – Lonza and Junshi Biosciences announced today that the first healthy volunteer has been dosed in a Phase I clinical study of JS016 at Huashan Hospital affiliated to Fudan University in China in June. JS016 is the first SARS-CoV-2 neutralizing antibody that has entered clinical trials in China and is produced using Lonza'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.