China CDE Approved First Universal CAR-T IND !

On March 17, 2022 Nanjing Bioheng Biotech Co., Ltd reported that China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ) (Press release, Bioheng Biotech, MAR 17, 2022, View Source;301505078.html [SID1234610288]).

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"The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies", said Xiaohong He, CEO of Bioheng."It will further accelerate the development and commercialization of "off-the-shelf" allogeneic CAR-T, which potentially offers greater benefits to patients over autologous CAR-T. We look forward to pushing more such disruptive products to clinical and providing more choices to solve the unmet medical needs and treatment accessibility".