While cell and gene therapies are all the rage now, a little known fact is that the world’s first approved gene therapy actually came from a Chinese company – in 2003! Gendicine® was a gene therapy for the treatment of haemophilia B. While China mostly lost the advantage of that head start, a spate of regulatory reforms over the past few years has inspired the country’s biotech entrepreneurs to return to this space in a frenzy. Today, China ranks second in the number of cell and gene clinical trials initiated. Learn about four must-known cell and gene companies in China below.
Sibiono GeneTech, Shenzhen
We have to mention Sibiono GeneTech, the developer of Gendicine®. It also stands out from the rest of the companies on this list for a couple more reasons: it is based in Shenzhen in southern China, and it is today helmed by a female CEO, XU Wei. The novelty of Gendicine® as the world’s first gene therapy even nabbed a cover on TIME magazine. However, the company proved to be a one-hit wonder as over 17 years after its first product approval, Gendicine® remains the only commercial product of the company, in part due to a number of scandals and controversies involving its founder, Dr PENG Zhaohui, who left the company around 2013. However, the company is now working on a adenovirus vector platform, and hopes to turn its fortunes around.
The nondescript name of this company belies the two heavyweights that came together to form it: JW Therapeutics was established in February 2016 by US CAR-T frontrunner Juno Therapeutics and Chinese biopharma manufacturing giant WuXi AppTec. Over the past four years, leveraging Juno’s * therapy, JW Therapeutics has built an integrated platform focused on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors for the Chinese market. Its lead product, relmacabtagene autoleucel (Relma-cel) is an anti-CD19 CAR-T therapy for relapsed or refractory (“r/r”) B-cell lymphoma, and its NDA was accepted for review by the Chinese NMPA in June 2020. In the same month, the company raised a USD 100 million Series B round. CEO James Li was the founding general manager for Amgen China, before which he was Partner at leading investment fund Kleiner Perkins Caufield & Byers (KPCB). His extensive industry experience also includes over 15 years with MSD across the US, Asia-Pacific and China.
Fosun Kite Biotechnology
This company chose to display its pedigree in its name: Fosun Pharmaceutical Group is one of the largest pharma companies in China, based in Shanghai, and Kite Pharma (now a part of Gilead Sciences) is yet another CAR-T pioneer, having launched, YESCARTA®, the second CAR-T therapy approved in the US, in 2017. Led by Dr Richard Wang, who has over 20 years of experience across R&D and management in both the US and China, with companies like BMS, AstraZeneca and GSK, Fosun Kite Biotechnology was established in 2017. Wasting no time, it opened an approx. 10,000 sqm commercial manufacturing facility in Zhangjiang Innovative Medicine Industrialization Park in Shanghai in December 2019. Its lead candidate, Axicabtagene Ciloleucel (FKC876), NDA filing for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy was granted priority review by the Chinese NMPA in March 2020.
Shanghai UniCAR Therapy
Homegrown UniCAR Therapy may not have the firepower of the previous two companies on the list but CEO Dr YU Lei is a pioneer in the gene therapy field, and the company has already made great strides. In 2018, UniCAR submitted four IND applications for CAR-T drug candidates. Its advanced CAR T2.0 technologies purportedly are designed to reduce the side effects of treatments and improve patient outcomes. The same year, UniCAR Therapy also established a partnership with Japanese medtech player Terumo BCT to open a Center of Excellence in Shanghai to automate its cell therapy manufacturing process.