China CDE Approved First Universal CAR-T IND !

NANJING, China, March 17, 2022 /PRNewswire/ -- On March 17, 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 Nanjing 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 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".

About Bioheng

Nanjing Bioheng Biotech Co., Ltd. (Bioheng), founded in 2017, is a leading biomedical company specialized in the development and commercialization of allogeneic cellular immunotherapy. At present, Bioheng has established 7500m2 high-standard translational center and GMP-level manufacturing plant that is in compliance with NMPA and FDA regulatory guidelines.

In March 2021, Bioheng secured an $ 80 million of serial B round of investment co-led by Hillhouse Venture Capital, Decheng Capital and Octagon Capital, accumulating 100 million of financing within 4 years. By November 2021, Bioheng has applied 52 core patents, and been selected for "Cultivating Unicorn Enterprises", "Nezha Enterprise", "Entrepreneurship and Innovation Talents" Program of Jiangsu Province, Nanjing High-level Entrepreneurial Talent Plan, Nanjing Expert Studio, etc. Bioheng has been awarded National Science and technology SMEs, National Intellectual Property Management Enterprise, Nanjing Immunotherapy Excellence Center, etc.

Bioheng is a global leader in developing allogeneic "off-the-shelf" universal CAR-T cell therapy, which may fundamentally solve the dilemma of "high cost, long waiting time, difficult manufacturing and individualization" of traditional CAR-T therapy, and ultimately realize the affordability and accessibility of immunotherapy. Committed to "bridge the life and health", Bioheng is dedicated to provide every patient an equal chance of cure.

SOURCE Nanjing Bioheng Biotech Co., Ltd