Brief: Carsgen Therapeutics Says Clinical Hold In U.S. Due To CMC Related Questions

CARsgen Therapeutics Holdings

12/12/2023 16:56

Dec 12 (Reuters) - CARsgen Therapeutics Holdings Ltd
 2171.HK :
    * CLINICAL HOLD IN U.S. DUE TO CMC RELATED QUESTIONS
    * UNIT HAS RECEIVED A NOTICE IN EVENING OF DECEMBER 11,
BEIJING
TIME, FROM U.S. FDA
    * NOTICE TO EFFECT THAT CT053, CT041, AND CT071 BE PUT ON
CLINICAL
HOLD
    * CO WILL CONDUCT A COMPREHENSIVE REVIEW AND IMPROVEMENT ON
CURRENT GOOD MANUFACTURING PRACTICE
    * CLINICAL HOLD PENDING RESOLUTION OF FINDINGS FOLLOWING AN
INSPECTION OF MANUFACTURING SITE LOCATED IN NORTH CAROLINA

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 ((Reuters.Briefs@thomsonreuters.com;))