| Products/Services Used | Details | Operation |
|---|---|---|
| Immunoassay Development Services | The first Chinese IND approval for an immunotherapy using CAR-T was granted on 13 March 2018 to Nanjing Legend Biotech Co., a subsidiary of GenScript Biotech Corporation (HKG: 1548), an investment holding company with activities in many countries. | Get A Quote |
This report describes changes to cell therapy research and clinical practice in China as a result of guidelines from the central government finalized at the end of 2017. The tables list Chinese authorities and regulations on human cells for medical research over the years 1993-2018. Under the new regulations, cell therapy products (CTPs) are treated like drugs, in alignment with policy in the USA and European Union. At civil institutions in China, there are now two pathways for human clinical trials: research versus pharmaceutical development. At the end of 2018, trials of CTPs were only authorized at 114 approved hospitals. It is hoped that the new policies will help CTPs developed in China gain acceptance by... More
