JW Therapeutics, kambani yakazvimirira yebiotechnology yakatarisana nekugadzira, kugadzira nekutengesa zvigadzirwa zvema cell immunotherapy, yakazivisa kuti National Medical Products Administration (NMPA) yekuChina yakagamuchira iyo yekuwedzera New Drug Application (sNDA) yeayo anti-CD19 autologous chimeric antigen receptor T ( CAR-T) cell immunotherapy chigadzirwa Carteyva® (relmacabtagene autoleucel jekiseni) yekurapa varwere vakuru vane relapsed kana refractory follicular lymphoma (r/r FL). Ichi ndicho chechipiri chekushambadzira chikumbiro paCarteyva® chakatumirwa neJW Therapeutics, uye inotarisirwa kuve yekutanga sero therapy chigadzirwa chakabvumidzwa muChina chekurapa r/r FL varwere. Carteyva® yakapihwa Breakthrough Therapy Designation neNMPA munaGunyana 2020.
Iyo sNDA yakatsigirwa nemhedzisiro yekiriniki kubva kuboka B reruwoko rumwe, akawanda-pakati, pivotal kudzidza (RELIANCE kudzidza) paCarteyva® muvarwere vakuru vane kudzokazve kana refractory B cell non-hodgkin lymphoma muChina. Mhedzisiro yezvidzidzo yakapihwa pa63rd American Society of Hematology (ASH) Musangano Wepagore muna Zvita 2021. The cohort B zvawanikwa zvakaratidza kuti Carteyva® yakaratidza yakakwira zvakanyanya yekugara kwenguva refu kwechirwere chemhinduro (Best Complete Response Rate uye Yese Response Rate pamwedzi ye3 yaive. 92.6% uye 100%, zvichiteerana) uye inodzoreka CAR-T inobatanidza chepfu muvarwere vane r / r FL (42.9% uye 17.9% yevarwere vaive nechero giredhi Cytokine Release Syndrome (CRS) uye Neurotoxicity (NT), nepo 0% uye 3.6% yevarwere vakawana CRS uye NT yeGiredhi 3 kana pamusoro).
Muzvinafundo Yuqin Song, Chiremba Mukuru weDhipatimendi reLymphoma paPeking University Cancer Hospital, Director weChina Society of Clinical Oncology (CSCO), akacherekedza pa63rd American Society of Hematology (ASH) Musangano Wepagore: "RELIANCE mhedzisiro yeongororo inoratidza kuti Carteyva® yakaratidza. Kubudirira kwakanyanya uye kuchengetedza chimiro muvarwere vane r/r FL uye isu tiri kutarisira kubvumidzwa kweSNDA muChina. "
ZVOKUBVA MUNYAYA INO:
- Iyo sNDA yakatsigirwa nemhedzisiro yekiriniki kubva kuboka reboka B reruwoko rumwe, akawanda-pakati, pivotal kudzidza (RELIANCE kudzidza) paCarteyva® muvarwere vakuru vane kudzokazve kana refractory B cell non-hodgkin lymphoma muChina.
- JW Therapeutics, kambani yakazvimirira yebiotechnology yakatarisana nekugadzira, kugadzira uye kutengesa zvigadzirwa zvema cell immunotherapy, yakazivisa kuti National Medical Products Administration (NMPA) yekuChina yakagamuchira iyo yekuwedzera New Drug Application (sNDA) yeayo anti-CD19 autologous chimeric antigen receptor T ( CAR-T) cell immunotherapy chigadzirwa Carteyva® (relmacabtagene autoleucel jekiseni) yekurapa varwere vakuru vane relapsed kana refractory follicular lymphoma (r/r FL).
- Ichi ndicho chechipiri chekushambadzira chikumbiro paCarteyva® chakatumirwa neJW Therapeutics, uye inotarisirwa kuve yekutanga sero therapy chigadzirwa chakabvumidzwa muChina chekurapa r/r FL varwere.