NEWS

Domestic first CAR-T products listed soon

Release time:

2021-01-27 10:10

The first domesticCAR-TProductsListing soon

Fosun Kate'sCD19 CAR-TTherapy Ekirilensai injection is expected to be obtained in the near future.NMPAApproved for listingOnce approved, it will become the first in China and the fourth in the world to be approved for listing.CAR-TTherapy Products, ChinaCAR-TTreatmentLawIt will also open a new chapter for domestic tumor immunotherapy..

CAR-TTherapy

CAR-TCell therapy mainly usesTCells initiate the body's natural host defense mechanisms.Unlike traditional cancer drugs,CAR-Tthrough to patientsDNAImport encoding inCARpair of genes.Tcells are modified,TIn vivo expression in patients with reinfusion after cell proliferationCARIt can kill target cells.CAR-TCan recognize tumor antigens without major histocompatibility complex(MHC)the limitations of being able to identifyMHCnon-dependent targets, while signal enhancement by co-stimulatory moleculesTcellular immunity to kill, thereby overcoming the downregulation of tumor cells dueMHCImmune escape by expressing or inhibiting the secretion of costimulatory molecules.CAR-Tis a genetically modifiedTcells, more than ordinaryTThe cells are more capable of targeting tumor cells.

Ekirilensai Injection

Ekirilensai injection is Gilead/KitePharmaceutical DevelopmentCD19CAR-TCell Injection (Trade NameYescarta)The product will be developed for the treatment of relapsed or refractory large after two or more lines of systemic therapy.Bcell lymphoma, including: diffuse largeBcell lymphoma (DLBCL1) Non-specific type, primary intermedialBcell lymphoma (PMBCL), high-levelBCell lymphoma and follicular lymphoma transformedDLBCL.

CAR-Tcompetitive landscape

Currently, there are three approved listings worldwide.CAR-TCellular immunotherapy products, includingKitePharmaceuticalYescartaandTecartusand Novartis'sKymriahAll three are targeted.CD19.CAR-TProvides a new treatment, and shows a breakthrough efficacy, autologous-CD19-CAR-TClinical trials of cells in adults and childrenr/r ALLPatients received up93%the remission rate, inr/r CLLUse in patientsCAR-TThe clinical trials conducted by the cells showed that the total effective rate (ORR) Gundam75%, complete remission (CR) Gundam66%, similarlyCAR-TUnprecedented response rates have also been demonstrated in some lymphoma patients.

To date, the global market has366SectionCAR-Tin the research,3SectionCAR-TProducts are approved for listing. On the domestic front, apart from Fosun Kate, only Yao Ming Ju Nuo's familyCAR-TProduct Ruikiren Sai listed. In addition, there are multipleCAR-TIn the clinical stage, which Nanjing legend.BCMATargetingCAR-Thas been2020Year8month wasCDEIncluded in breakthrough therapy programs.

Although European and American pharmaceutical companiesCAR-TThe field is at the forefront, but Chinese pharmaceutical companies are also trying to catch up, believing Fosun KateYescartaAfter listing will be inCAR-TA share of the market.

Listing, car-t, cell, therapy, lymphoma, product, patient, domestic, treatment