Perts i.m. has filed an application for listing of CAR-T therapy in Japan.

It is understood that liso-cel was developed by Juno (newly acquired by Juno in January 2018 for $9 billion), which is a CAR-T cell therapy for CD19 antigens with 4-1BB as a co-stimulation zone, in which CD4 plus CD8 plus CAR-T cells have an accurate 1:1 ratio, which can better control the toxic side effects of cell therapy, liso-cel has been awarded breakthrough drug qualification by the U.SFDA and advanced regenerative medicine treatment recognition (RMAT), in early January last year, The company announced the acquisition of New Base for $74 billion after a series of twists and turns, the acquisition was finally completed on November 21, 2019, and the resulting baishi-Mei-Siguibao will be liso-cel revenueit is understood that this application is based on a clinical trial of patients with recurrent or refractive B-cell non-Hodgkin's lymphoma (B-NHL) code-named TRANSCEND NHL 001, as well as data on the safety and efficacy of a global phase II study involving Japanese patients covering recurrent or refractive invasive B-NHLTHE TOTAL NUMBER OF PATIENTS WITH RELAPSE/DIFFICULTLBCL (INCLUDING DLBCL) WAS ENROLLED IN THE TRANSCEND NHL 001 TRIAL, AND THE DATA SHOWED THAT THE TOTAL REMISSION RATE OF LISO-CEL THERAPY (ORSO-CEL) IN PATIENTS WITH ASSESSABLE EFFICACY (N-256) R) is 73% (187/256, 95% CI:67-78) and the total mitigation rate (CR) is 53% (136/256, 95% CI:47-59)remission is similar in all patient subgroupsmedian follow-up for 12 months (95% CI: 11.2-16.7), median mitigation duration (DOR) has not yet reached (95% CI: 8.6-NR)median progression-free survival (PFS) was 6.8 months (95% CI: 3.3-14.1) and median total lifetime (OS) was 21.1 months (95% CI:13.3-NR)patients whose condition was completely remissioned, median PFS and OS were not yet reached, and at 12 months, 65.1% of patients did not progress and 85.5% survivedin terms of safety, 79 percent (213/269) of all patients have a level 3 or higher therapeutic emergency event (TEAE), including neutrophilia, anemia, and platelet reduction42% (113/269) had cytokine release syndrome (CRS), with a median onset of 5 days, and 2% (6/269) had a level 3 or higher of CRS30% of patients (80/269) have neurological events (NEs) and 10% (27/269) have ALevel 3 or higher NEs's application for listing is expected to make it the third CAR-T cell therapy approved for the listing after Novartis's Kymriah and First SanPharmaceutical's CD19 CAR-T Cell Therapy Yescarta (axicabta cilgeneoleucel)in fact, liso-cel is not the first Car-T therapy submitted by Baxter,, and in April, Baxter and Bluebird announced that they had filed their CAR-T treatment spicos with the U.SFDA for a biologic syll(BR) for relapse/difficult-to-treat myeloma.comthis is the world's first CAR-T treatment targeting BCMA to submit a listing applicationbb2121 therapy is the embedded B-cell maturation antigen (BCMA) receptor on the patient's T-cells, in which MM patients receive two pretreatments of the chemotherapy drug cyclophosphamide and fluodaline to kill their existing T cells, and then enter BCMA CAR-T cells to find and kill MM cells containing BCMA, whose FDA and EMA have been granted breakthrough therapy and priority drug qualification original title: "Cell Therapy" 100-day Mei ShiGuibao in Japan to submit a CAR-T therapy listing application, or become Japan's 3rd CAR-T therapy.