US EditionCARsgen's Satri-cel Granted Priority Review by the NMPA
- CARsgen Therapeutics Holdings Limited announced on May 28, 2025, that its satricabtagene autoleucel received Priority Review from China's NMPA for treating advanced gastric/gastroesophageal junction adenocarcinoma .
- The Priority Review follows earlier Breakthrough Therapy Designation by the NMPA in March 2025 and FDA Regenerative Medicine Advanced Therapy and Orphan Drug designations for satri-cel granted since 2020.
- Satri-Cel is an autologous CAR T-cell therapy targeting Claudin18.2-positive tumors in patients who failed at least two prior treatment lines, reflecting CARsgen's focus on innovative cell therapies.
- The U.S. FDA granted Orphan Drug status in September 2020 and the NMPA's Priority Review recognizes satri-cel’s potential against G/GEJA as a critical indication.
- The review status could accelerate regulatory approval and support CARsgen's mission to offer novel cancer treatments, though forward-looking statements highlight uncertainties about final outcomes.
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Chatham Star Tribune+57 Reposted by 57 other sources
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Priority…
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Total News Sources58
Leaning Left6Leaning Right6Center17Last UpdatedBias Distribution59% Center
Bias Distribution
- 59% of the sources are Center
59% Center
L 21%
C 59%
R 21%
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