ŠANGHAJ, KITAJSKA, 10. oktober 2022 – JW Therapeutics (HKEX: 2126), neodvisno in inovativno biotehnološko podjetje, ki se osredotoča na razvoj, proizvodnjo in trženje izdelkov celične imunoterapije, je objavilo, da je Kitajska nacionalna uprava za medicinske izdelke (NMPA) odobrila dodatno prijavo za nova zdravila (sNDA) za njegov avtologni anti-CD19 celična imunoterapija s himernim antigenskim receptorjem T (CAR-T). izdelek relmacabtagene autoleucel injekcija (v nadaljevanju okrajšano kot relma-cel, trgovsko ime: Carteyva®) za zdravljenje odraslih bolnikov s folikularnim limfomom, ki je neodziven ali se ponovi v 24 mesecih po drugem ali višjem sistemskem zdravljenju (r/r FL). To je druga odobrena indikacija za relma-cel po začetni odobritvi in lansiranju septembra lani, zaradi česar je prvi izdelek za celično imunoterapijo, odobren na Kitajskem za zdravljenje bolnikov z r/r FL.
Morda boste radi prebrali: CAR T Celična terapija na Kitajskem
Ta odobritev temelji na 6-mesečnih kliničnih rezultatih iz kohorte B večcentrične ključne študije z enim krakom (študija RELIANCE) o zdravilu Carteyva.® pri odraslih bolnikih z relapsom ali neodzivnim B-celičnim ne-Hodgkinovim limfomom na Kitajskem. 3-mesečni podatki so bili predstavljeni na 63rd Letno srečanje Ameriškega združenja za hematologijo (ASH) decembra 2021. Rezultati kohorte B so pokazali, da je Carteyva® pokazala zelo visoke stopnje trajnega odziva na bolezen (celotna stopnja odziva (ORR) = 100 %, stopnja popolnega odziva (CRR) = 85.19 % v 3. mesecu; ORR = 92.58 %, CRR = 77.78 % v 6. mesecu) in obvladljiv CAR-T povezane toksičnosti pri bolnikih z r/r FL. Glede na trenutno razpoložljiva zdravljenja na Kitajskem, Carteyva® lahko postane možnost zdravljenja z višjim razmerjem med koristjo in tveganjem za bolnike z r/r FL in ima potencial, da postane najboljši izdelek CAR-T v svojem razredu.
Profesor Yuqin Song, glavni raziskovalec študije RELIANCE, namestnik direktorja oddelka za limfome in podpredsednik Univerzitetna bolnišnica za raka v Pekingu, je komentiral: »Skupna stopnja odziva (ORR) končne točke učinkovitosti je bila več kot 90 %, splošni varnostni profil pa je bil obvladljiv. Remal-cel je postal prvi Imunoterapija CAR-T celic izdelek za zdravljenje r/r FL na Kitajskem.”
Morda boste radi prebrali: CAR T Celična terapija za multipli mielom na Kitajskem
James Li, soustanovitelj, predsednik in izvršni direktor JW Therapeutics, je dejal: »Hvala pacientom in raziskovalcem, ki so prispevali h kliničnim študijam Carteyve.®, in hvala regulatorjem za priznanje Carteyve®. 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 imunoterapija izdelkov. "
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 limfom (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 limfom plaščnih celic (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
O injekcijah Relmacabtagene Autoleucel (trgovsko ime: Carteyva®)
Relmacabtagene autoleinjekcija ucel, ki se prodaja tudi pod blagovno znamko Carteyva®. Je avtologna anti-CD19 CAR-T celična imunoterapija 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 Izdelek CAR-T na Kitajskem ki je bil hkrati vključen v Nacionalni program za razvoj pomembnih novih zdravil, prednostni pregled in imenovanja prelomnih terapij.
Morda boste radi prebrali: CAR T Cena celične terapije na Kitajskem
O 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.
