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Recently, according to the official website of the Drug Audit Center of the State Drug Administration, Heyuan Biotech CNCT19 (anti-CD19 chime antigen-liked antigen subject T-cell injection) was awarded by CDE to treat recurrence or refractory acute lymphoblastic leukemia (ALL) to be included in the breakthrough treatment varieties, adaptation for recurrence or refractory acute lymphoblastic leukemia.
It is understood that heyuan bioCCT19 cell injection is an independent intellectual property rights for CD19 target CAR-T cell therapy products, in the same period in November 2019 obtained two new drug clinical trial license of the National Drug Administration, respectively, the treatment of relapsed or resoccurring acute lymphoblastic leukemia clinical trial (ALL) (receiving) No.: CXSL1800106) and clinical trials for the treatment of recurring or recurring invasive B-cell non-Hodgkin's lymphoma (NHL) (acceptance number: CXSL1800107), both trials have now completed Phase II clinical studies, based on the progress of the hemo-source biological product pipeline.
according to the information of heyuan biological website, CNCT19 cell injection showed excellent safety and effectiveness in the early exploratory clinical study.
, its production process and quality control system in line with domestic international standards, key parameters to reach the international leading level, the company is accelerating the CNCT19 cell injection registration clinical research process.
, in June 2019, US company CASI signed a licensing agreement with Heyuan Bio to obtain a global exclusive commercial interest in the CNCT19 project.
so far, in addition to CNCT19, CAR-T therapies such as legendary creature LCAR-B38M, JWCAR029 of Drug Ming Juno, and CT053 of Kozi Bio have been included in the breakthrough treatment varieties.
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