Domestic autonomous CAR-T therapy was included in the breakthrough treatment varieties

According to the official website of the Drug Audit Center of the State Drug Administration, the co-source biological CAR-T cell therapy product CNCT19 cell injection (anti-CD19 chime antigen-liked antigen t-cell injection) was approved to be included in the "breakthrough treatment drug" (CDE acceptance number: CXSL1800106), the intended indication is relapsed or refractory acute lymphoblastic leukemia.
It is understood that there are currently no CAR-T products approved worldwide for adult recurrence or recurring acute lymphoblastic leukemia, and three CAR-T therapies have previously been approved for sale, Kymriah for the treatment of B-cell precursor acute lymphatics under 25 years of age, recurring or two or more relapses Patients with cell leukemia (ALL), patients with B-cell acute lymphoblastic leukemia (B-ALL) who have relapsed or relapsed twice or more after transplantation, and patients with relapsed or incurable large B-cell lymphoma (DLBCL) after two or more systemic treatments in adulthood.
yescarta has been approved for the treatment of adult patients with specific types of large B-cell lymphoma.
In August 2018, the European Union approved Yescarta for the treatment of adult patients with recurring or re treatable large B-cell lymphoma (DLBCL) and primary diffuse large B-cell lymphoma (PMBCL) twice or more in adulthood, and this year approved Tecartus for the treatment of adult patients with recurring or resuscable heterocytoblast lymphoma (MCL).
CNCT19 cell injection is a CAR-T cell therapy product with independent intellectual property rights of hemolytic organisms, derived from the Hospital of Hematology of the Chinese Academy of Medical Sciences (Institute of Hematology of the Chinese Academy of Medical Sciences), november 29, 2019, CNCT19 cell injection was approved by the State Drug Administration for clinical trials of two new drugs, respectively, for the treatment of relapsed or resoccurring acute lymphocytes. Clinical trials of leukemia (acceptance number: CXSL1800106) and clinical trials for the treatment of recurring or refractic invasive B-cell non-Hodgkin's lymphoma (acceptance number: CXSL1800107), both clinical trials are currently the first to enter the registered clinical phase II, according to the progress of the heyuan biological products pipeline, both trials have been completed phase II clinical research.
According to pre-clinical research data, CNCT19 cell injections in the treatment of adult recurrence or recurring acute lymphoblastic leukemia show excellent efficacy and safety, the total remission rate of more than 90%, the current maximum survival has been more than 3 years, before the source of biological prediction of the product or will be put on the market in 2022.
, 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 LCAR-B38M, JWCAR029 of Drug Ming Juno, and CT053 of Kozi Bio have been included in breakthrough treatments.
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