China’s CARsgen Therapeutics Holdings Ltd (HKG: 2171), a chimeric antigen receptor (CAR)-T cell specialist, has initiated Good Manufacturing Practice (GMP)-compliant production at its new autologous CAR-T cell therapy plant in North Carolina’s Research Triangle Park (RTP). The facility marks the company’s first manufacturing site outside China and will supply clinical trial batches for North American and European studies.
Facility Details
The 3,300-square-meter plant will produce CAR-T cell products for up to 700 patients annually. The site supports CARsgen’s clinical trials and early commercialization plans in North America and Europe, with initial batches already released for clinical use.
Clinical Pipeline
CARsgen operates two North American trials:
- CT053 (BCMA CAR-T): A pivotal Phase II study in relapsed/refractory multiple myeloma.
- CT041 (Claudin18.2 CAR-T): A Phase Ib study in advanced gastric and pancreatic cancers.
Global Platform
The company’s integrated cell therapy platform spans target discovery, antibody development, clinical trials, and commercial production. With operations in China and the US, CARsgen aims to accelerate global access to its CAR-T therapies.-Fineline Info & Tech
