Bioheng Received CDE IND Approval for CTA101 UCAR-T
Release Time:
2022-03-17
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On March 17th, 2022, 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 Bioheng Biotech Co., Ltd ( hereinafter referred as ' Bioheng), targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ).
“The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies”, said Lu Han, 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”.
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