SHANGHAI, CHINA, 10 Oktober 2022 – JW Therapeutics (HKEX: 2126), 'n onafhanklike en innoverende biotegnologiemaatskappy wat fokus op die ontwikkeling, vervaardiging en kommersialisering van sel-immunoterapie-produkte, het aangekondig dat die Nasionale Mediese Produkte-administrasie (NMPA) van China die aanvullende nuwe geneesmiddelaansoek (sNDA) vir sy anti-CD19 outoloog chimeriese antigeen reseptor T (CAR-T) sel immunoterapie produk relmacabtagene autoleucel inspuiting (hierna afgekort as relma-cel, handelsnaam: Carteyva®) vir die behandeling van volwasse pasiënte met follikulêre limfoom wat refraktêr is of wat terugval binne 24 maande van tweede-lyn of hoër sistemiese behandeling (r/r FL). Dit is die tweede goedgekeurde aanduiding vir relma-cel ná sy aanvanklike goedkeuring en bekendstelling in September verlede jaar, en dit maak dit die eerste sel-immunoterapieproduk wat in China goedgekeur is vir die behandeling van r/r FL-pasiënte.
U wil dalk lees: CAR T-selterapie in China
Hierdie goedkeuring is gebaseer op die kliniese resultate van 6 maande van kohort B van 'n enkelarm, multi-sentrum, deurslaggewende studie (RELIANCE-studie) op Carteyva® in volwasse pasiënte met terugval of refraktêre B-sel nie-Hodgkin limfoom in China. Die 3-maande data is by die 63 aangebiedrd American Society of Hematology (ASH) Jaarvergadering in Desember 2021. Die kohort B-resultate het getoon dat Carteyva® het baie hoë koerse van duursame siekterespons getoon (algehele responskoers (ORR)=100%, volledige responskoers (CRR)=85.19% op maand 3; ORR=92.58%, CRR=77.78% op maand 6) en beheerbare CAR-T geassosieerde toksisiteite by pasiënte met r/r FL. Gegewe die tans beskikbare behandelings in China, Carteyva® kan 'n behandelingsopsie word met 'n hoër voordeel-risiko-verhouding vir pasiënte met r/r FL, en het die potensiaal om 'n beste-in-klas CAR-T-produk te word.
Professor Yuqin Song, die hoofondersoeker van RELIANCE-studie, adjunkdirekteur van die limfoomdepartement, en visepresident van Peking Universiteit Kanker Hospitaal, het kommentaar gelewer, "Die algehele responskoers (ORR) van die doeltreffendheidseindpunt was meer as 90%, en die algehele veiligheidsprofiel was hanteerbaar. Remal-cel het die eerste geword CAR-T-sel-immunoterapie produk vir die behandeling van die r/r FL in China.”
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James Li, medestigter, voorsitter en uitvoerende hoof van JW Therapeutics, het gesê: "Dankie aan die pasiënte en ondersoekers wat bygedra het tot die kliniese studies van Carteyva®, en dankie aan die reguleerders vir die erkenning van Carteyva®. We are pleased with the second approved indication, which provides a new and breakthrough treatment option for r/r FL patients. JW Therapeutics is committed to maximizing the value of Carteyva®, continuously advancing technology innovation and pipeline development, and improving the accessibility of cell immunotherapie produkte. "
As the first product of JW Therapeutics and the first CAR-T product approved as a Category 1 biologics product in China, relma-cel has been approved for two indications in China, including the treatment of adult patients with relapsed or refractory large B-cell limfoom (r/r LBCL) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL). JW Therapeutics is currently doing or plans to do more clinical studies on hematologic malignancies and autoimmune diseases to fully explore the clinical potential of Carteyva®. These include third-line mantelsell limfoom (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
Oor Relmacabtagene Autoleucel Injection (handelsnaam: Carteyva®)
Relmacabtagene autoleucel inspuiting, wat ook onder die handelsnaam Carteyva® verkoop word. Dit is 'n outoloog anti-CD19 CAR-T sel immunoterapie product that was built on a CAR-T cell process platform from Juno Therapeutics, a Bristol Myers Squibb company. Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T produk in China wat gelyktydig ingesluit is in die Nasionale Beduidende Nuwe Dwelmontwikkelingsprogram, prioriteitshersiening en deurbraakterapie-benamings.
U wil dalk lees: CAR T Selterapie koste in China
Oor JW Therapeutics
JW Therapeutics (HKEX: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing, and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering both hematologic malignancies and solid tumors. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China’s cell immunotherapy industry.
