SHANGHAI, CHINA, Gumiguru 10, 2022 - JW Therapeutics (HKEX: 2126), kambani yakazvimirira uye inovandudza biotechnology yakatarisana nekugadzira, kugadzira, uye kutengesa zvigadzirwa zvema cell immunotherapy, yakazivisa kuti National Medical Products Administration (NMPA) yekuChina yabvumidza iyo yekuwedzera New Drug Application (sNDA) ye anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy chigadzirwa relmacabtagene autoleucel jekiseni (pano yakapfupikiswa se relma-cel, zita rekutengesa: Carteyva®) kurapwa kwevarwere vakuru vane follicular lymphoma iyo inopesana kana iyo inodzoka zvakare mukati memwedzi ye24 yemutsara wechipiri kana pamusoro pechirongwa chekurapa (r / r FL). Ichi chiratidzo chechipiri chakatenderwa cherelma-cel zvichitevera kubvumidzwa kwayo kwekutanga uye kutangwa munaGunyana gore rapfuura, uye inoiita yekutanga sero immunotherapy chigadzirwa chakabvumidzwa muChina kurapwa kwer/r FL varwere.
Unogona kuda kuverenga: CAR T Cell kurapa muChina
Mvumo iyi yakavakirwa pamhedzisiro yemwedzi mitanhatu yekiriniki kubva kuboka B reruoko rumwechete, rwakasiyana-siyana, chidzidzo chakakosha (RELIANCE kudzidza) paCarteyva.® muvarwere vakuru vane kudzokazve kana refractory B cell isiri Hodgkin lymphoma muChina. Iyo data yemwedzi mitatu yakaunzwa ku3rd American Society of Hematology (ASH) Annual Meeting muna Zvita 2021. Cohort B zvawanikwa zvakaratidza kuti Carteyva® yakaratidza huwandu hwepamusoro-soro hwemhinduro yechirwere chekugara (yakazara mhinduro (ORR) = 100%, yakakwana yekupindura mwero (CRR) = 85.19% pamwedzi 3; ORR = 92.58%, CRR = 77.78% pamwedzi 6) uye inodzoreka CAR-T yakabatana chepfu muvarwere vane r/r FL. Tichifunga nezve marapiro aripo parizvino muChina, Carteyva® inogona kuve sarudzo yekurapa ine yakakwira bhenefiti-ngozi reshiyo kune varwere vane r/r FL, uye ine mukana wekuve yakanakisa-mu-kirasi CAR-T chigadzirwa.
Muzvinafundo Yuqin Song, muongorori mukuru weRELIANCE kudzidza, Mutevedzeri Mukuru weDhipatimendi reLymphoma, uye Mutevedzeri weMutungamiriri we Peking University Cancer Hospital, akataura, "Chiyero chekupindura kwese (ORR) chekupedzisira chekushanda chakanga chiri pamusoro pe90%, uye iyo yose yekuchengetedza purogiramu yaigona kugadziriswa. Remal-cel yave yekutanga CAR-T cell immunotherapy chigadzirwa chekurapa r/r FL muChina. "
Unogona kuda kuverenga: CAR T Sero kurapwa kweyakawanda myeloma muChina
James Li, co-muvambi, sachigaro, uye CEO weJW Therapeutics, akati, "Ndinotenda kuvarwere nevaongorori vakabatsira muzvidzidzo zvekiriniki zveCarteyva.®, uye nekutenda kune vanodzora nekuda kwekuzivikanwa kweCarteyva®. 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 immunotherapy zvigadzirwa. ”
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 lymphoma (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 jasi cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).
About Relmacabtagene Autoleucel Injection (zita rekutengesa: Carteyva®)
Relmacabtagene autolejekiseni ucel, iyo inotengeswa zvakare pasi pezita rechiratidzo Carteyva®. Icho chinonzi autologous anti-CD19 CAR-T cell immunotherapy 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 chigadzirwa muChina iyo yakaverengerwa panguva imwe chete muNational Yakakosha New Drug Development Chirongwa, kutariswa kwekutanga, uye budiriro yekurapa mazita.
Unogona kuda kuverenga: CAR T Cell kurapwa mutengo muChina
Nezve 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.
