March 2023: CAR-T-sero kurapwa inyowani uye inoshanda nzira yekurapa cancer iyo yakashandura marapirwo egomarara, kunyanya kenza yeropa. Mushonga uyu unobudirira mukurapa kana kurapa chirwere nekugadzirisa kana kugadzirazve mageneti akakanganisika. Kubva Roseberg akatanga azvitsaura tumour-infiltrating lymphocytes (TILs) kurapa melanoma muna 1986, kuvandudzwa kweT cell therapy kwakawana kukurumidza kukuru. Sezvo FDA yakabvumidza yekutanga CAR-T kurapa, Kymriah, muna 2017, misika yeCAR-T yakakura nokukurumidza. Sekureva kwaFrost & Sullivan, saizi yemusika weCAR-T inotarisirwa kuwedzera kubva pamadhora gumi emamiriyoni muna 10 kusvika pamadhora bhiriyoni 2017 muna 1.08, uyezve kusvika paUS $ 2020 bhiriyoni muna 9.05, ine huwandu hwekukura kwepagore (CAGR) yemakumi mashanu neshanu. % kubva muna 2025 kusvika 55, zvichiita kuti ive chikamu chiri kukurumidza kukura chemusika wesero uye gene therapies (CGT).
CAR-T kurapwa ndechimwe chezvikamu zveCGT kurapa. Pahwaro hwekwakabva masero eT, kurapwa kweCAR-T kunogona kukamurwa kuita mapoka maviri. Autologous CAR-T-sero kurapwa, iyo inoshandisa masero ezvirwere zvemurwere pachake, uye allogeneic CAR-T-cell therapy, iyo inoshandisa masero eT kubva kuropa revanopa kana kuti dzimwe nguva umbilical cord blood. Ruzhinji rweCAR-T marapiro ari autologous CAR T-sero kurapwa, izvo zvinowanzobatanidza matanho anotsanangurwa pazasi:
Unogona kuda kuverenga: CAR T Cell kurapa muChina
1) T masero anotorwa kubva muropa remurwere;
2) Viral vectors dzakadai seAAV zvino shandura masero eT ane CAR genes anotungamirirwa kune chaiyo cell-surface protein pamasero ekenza;
3) Iyo yakagadziridzwa CAR-T masero ehuwandu inowedzerwa maererano nehuremu hwemurwere;
4) Masero eCAR-T akawedzerwa anobva adzoserwa zvakare mumurwere. Iyo yese nzira yekugadzira inotora pakati pevhiki imwe kusvika matatu uye inoda kuteedzera GMP munzvimbo yakanyatso kuchena.
Kurapa kweCAR-T kwasvika pamwero wekubudirira kusati kwamboonekwa mukurapa B-cell cancers inopesana kana kuti refractory kuchemotherapy, kusanganisira R / R, B-ALL, NHL, uye MM. Kushanda kwekurapa mabundu akasimba zvakare kuri kuferefetwa. CD19-yakananga uye BCMA-yakananga CAR-T marapirwo anowana budiriro huru yekiriniki pakati pezvese CAR-T marapirwo. Ina pamatanhatu eCAR-T marapirwo anotenderwa neFDA yakananga CD19, nepo maviri akananga BCMA.
Mukana wakanyanya kukosha pamusoro pemishonga midiki nehombe yemamorekuru ndeyekuti varwere vanogona kutsiva kurapwa kwehupenyu hwese kwechirwere chisingaperi nenhamba shoma yedosi, kana imwe chete.
IUnited States yakatanga kuvandudzwa kweiyo CAR-T indasitiri. Nekudaro, pakazosvika pakati pe2010s, China yakanga yadzidza nekukurumidza uye yakanga ichibata kuUnited States. Kunyanya, madhiraivha akakosha anogona kuverengerwa nerutsigiro rwehurumende yeChinese kusimudzira kweCGT ecosystem inoumbwa nemakambani ebiotech, vadzidzi, varapi vehutano, vanoisa mari, uye hurumende. Zvichitevera kukosheswa kwebiotechnology muchirongwa chemakore gumi nematatu, hurumende yeChina yakasimbisa hurongwa hwayo hwekukurumidzira kuvandudza nekusimudzira maindasitiri ebiotech, kusanganisira masero ekurapa. Pamusoro pezvo, makurukota akakodzera akapa mitemo inokurudzira yekuita.
Mushure mekuburitswa kweOpinions of the State Council on Reform of the System of Evaluation, Review, and Approval of Drugs and Medical Devices muna 2015, musika mukuru wakatangawo kushanda. Pakukura kwepagore kwekukura kwemakumi mana neshanu muzana, makambani eChinese cell-therapy akakwidza mari inosvika mabhiriyoni maviri nemazana mana emadhora emari pakati pa45 na2.4.
Unogona kuda kuverenga: CAR T Cell kurapwa mutengo muChina
Huwandu hwemaedzo eCAR-T ekurapa muChina hwakapfuura iwo muUnited States panosvika 2018 semhedzisiro yeiyi kusimukira ecosystem. Kubva muna Chikumi 2022, makambani ekuChina akange aita 342 kiriniki yeCAR-T miedzo. Mhosva dzemudzinza B dzaive pakati pezvaive zvanyanya kuratidzwa. Piri CAR-T zvigadzirwa zvine maapplication ekutengesa: Yescarta munaJune 2021 uye Relma-cel munaGunyana 2021, pakati pevazhinji vakakwikwidza zvinodhaka.
Sekureva kwaFrost & Sullivan, musika wemumba weCAR-T unofungidzirwa kuwedzera kubva kuCNY 0.2 bhiriyoni muna 2021 kuenda kuCNY 8 bhiriyoni muna 2025, uyezve kuCNY 28.9 bhiriyoni muna 2030, paCAGR ye45% kubva 2022 kusvika 2030. chokwadi chekuti musika weChinese CAR-T uchiri mukutanga, simba rekutyaira riripo.
Kunyangwe izvo zviviri zvakatenderwa zvigadzirwa zveCAR-T zvichibva kuSino-US majoint ventures Fosun Kite uye JW Terapeutics, vatambi vepamba vakaita budiriro uye vakabata kune vatambi vepasi rose mumakore achangopfuura. Legend Biotech, IASO Biotherapeutics, uye CARsgen Therapeutics vese vakawana mvumo yeNDA yezvigadzirwa zvavo zveBCMA CAR-T, vachivamisa sevatungamiriri muBCMA CAR-T kurapwa. CD19 CAR-T zvigadzirwa zvinotariswa kuJuventas Therapeutics, Gracell Biotechnologies, Hrain Biotechnology, ImunoPharm, Shanghai Cell Therapy Group, uye makambani mazhinji epamba. Juventas Therapeutics ndiye mutungamiri muChinese CD19 CAR-T kurapa now that the NMPA has accepted its NDA for CNCT19. CARsgen Therapeutics is a global leader in solid tumours, and CT041 is the first CAR-T candidate for treating solid tumours to enter Phase II kliniki miedzo. Bioheng Biotech uye BRL Biotech (Chinese: ) gadzira misika mitsva yeallogeneic CAR-T.
Unogona kuda kuverenga: CAR T Sero kurapwa kweyakawanda myeloma muChina
