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Shanghai's Pudong New Area gets closer to exporting China's first CAR T-Cell therapy 2024-06-12
Shanghai's Pudong New Area gets closer to exporting China's first CAR T-Cell therapy
Shanghai's Pudong New Area is advancing China's first Chimeric Antigen Receptor T-Cell immunotherapy commercial product export, laying institutional foundations for the new-type tumor therapy's expansion on overseas markets.
The cross-agencies joint review of the CAR T-Cell therapy exports has been completed, with the first business likely to begin in one to two months, Sun Jing, head of governmental affairs and public relations at JW Therapeutics, which is piloting the exports, said yesterday.
Exporting CAR T-Cell therapy differs from general drugs as it has strict time and transport requirements. Pharmaceutical companies must obtain immune cells from patients overseas and send them to a plant to make drugs within 44 hours. The end product must be stored in a minus 196-degree Celsius low-temperature liquid nitrogen tank and delivered to overseas medical institutions in seven days.
Twelve government agencies take part in the institutional innovation to meet special management requirements concerning exporting CAR T-Cell therapy, Sun noted. The innovation's success depends on support from central government-level agencies, Sun added.
Founded in 2016, Shanghai-based JW Therapeutics focuses on the research and development of cellular immunotherapy. It marketed its first CAR T-Cell therapy, Carteyva, in September 2021, which is approved to treat two kinds of lymphoma indications.
The central government released a plan to implement comprehensive reform trials in Pudong this January, providing the area with more rights to advance deeper-level reforms and higher-level opening-up.
Of the 139 reform missions raised in the scheme, 67 have been implemented, showing initial effects, said Chen Yanfeng, deputy director of Shanghai Municipal Development and Reform Commission.
Source: Yicai Global
Application Status
| 04-16 | 21315227 | Processing |
| 03-12 | 21315226 | Processing |
| 09-26 | 21315225 | Processing |
Inquiry Status
| 02-29 | 02131558 | Received |
| 03-06 | 02131557 | Received |
| 11-14 | 02131556 | Received |
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