JW Therapeutics, hujayra immunoterapiya mahsulotlarini ishlab chiqish, ishlab chiqarish va tijoratlashtirishga yo'naltirilgan mustaqil biotexnologiya kompaniyasi, Xitoyning Milliy Tibbiy Mahsulotlar Boshqarmasi (NMPA) o'zining anti-CD19 autolog kimerik antigen retseptorlari T () uchun qo'shimcha yangi dori dasturini (sNDA) qabul qilganini e'lon qildi. CAR-T) hujayrali immunoterapiya mahsuloti Carteyva® (relmakabtagene autoleucel in'ektsiyasi) relapsli yoki refrakter follikulyar limfoma (r/r FL) bo'lgan kattalardagi bemorlarni davolash uchun. Bu JW Therapeutics tomonidan taqdim etilgan Carteyva® bo'yicha ikkinchi marketing ilovasi bo'lib, Xitoyda r/r FL bemorlarini davolash uchun tasdiqlangan birinchi hujayra terapiyasi mahsuloti bo'lishi kutilmoqda. Carteyva® 2020-yil sentabr oyida NMPA tomonidan Reakthrough Therapy nominatsiyasiga ega bo‘ldi.
sNDA Xitoyda relapsli yoki refrakter B hujayrali nohodgkin lenfomasi bo'lgan kattalar bemorlarida Carteyva® bo'yicha bir qo'lli, ko'p markazli, asosiy tadqiqot (RELIANCE tadqiqoti) B kohortining klinik natijalari bilan tasdiqlangan. Tadqiqot natijalari Amerika Gematologiya Jamiyatining (ASH) 63-yil dekabr oyida boʻlib oʻtgan 2021-yillik yigʻilishida taqdim etildi. B kohorti natijalari shuni koʻrsatdiki, Carteyva® kasallikka chidamli javobning juda yuqori koʻrsatkichlarini koʻrsatdi (eng yaxshi toʻliq javob darajasi va 3 oyda umumiy javob darajasi r/r FL bo'lgan bemorlarda mos ravishda 92.6% va 100%) va nazorat qilinadigan CAR-T bilan bog'liq toksiklik (bemorlarning 42.9% va 17.9%) har qanday darajadagi sitokinlarni chiqarish sindromi (CRS) va neyrotoksiklik (NT), 0% va Bemorlarning 3.6% 3 yoki undan yuqori darajali CRS va NTni boshdan kechirgan).
Pekin universiteti saraton kasalxonasining limfoma bo'limi bosh shifokori, Xitoy Klinik Onkologiya jamiyati (CSCO) direktori professor Yuqin Song Amerika Gematologiya Jamiyatining (ASH) 63-yillik yig'ilishida shunday dedi: "RELIANCE tadqiqoti natijalari shuni ko'rsatadiki, Carteyva® r/r FL bo'lgan bemorlarda juda yaxshi samaradorlik va xavfsizlik profili va biz Xitoyda sNDA ma'qullanishini kutmoqdamiz.
USHBU MAQOLADAN NIMA OLISH KERAK:
- The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva® in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China.
- JW Therapeutics, an independent biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL).
- This is the second marketing application on Carteyva® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients.
