Maris 2023: CAR-T-cell far wani labari ne kuma ingantaccen tsarin maganin cutar kansa wanda ya kawo sauyi kan maganin cutar kansa, musamman kansar jini. Wannan maganin yana samun sakamako na warkewa ko warkar da cuta ta hanyar gyara ko sake gina kayan gadon da suka lalace. Tun da farko da Roseberg ya keɓe ƙwayar ƙwayar cuta-infiltrating lymphocytes (TILs) don magance melanoma a cikin 1986, haɓakar haɓakar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar cuta (TILs). Tun da FDA ta amince da farko CAR-T far, Kymriah, a cikin 2017, kasuwar CAR-T ta girma cikin sauri. Dangane da Frost & Sullivan, girman kasuwar CAR-T na duniya ana hasashen zai karu daga dala miliyan 10 a shekarar 2017 zuwa dala biliyan 1.08 a shekarar 2020, sannan zuwa dala biliyan 9.05 a shekarar 2025, tare da karuwar karuwar shekara-shekara (CAGR) na 55 % daga 2019 zuwa 2025, yana mai da shi yanki mafi girma cikin sauri na kasuwar kwayar halitta da kwayoyin halitta (CGT).
CAR-T far yana ɗaya daga cikin sassan jiyya na CGT. Dangane da asalin ƙwayoyin T, ana iya raba maganin CAR-T zuwa kashi biyu. Autologous CAR-T-cell far, wanda ke aiki da ƙwayoyin rigakafi na majiyyaci, da kuma allogeneic CAR-T-cell therapy, wanda ke amfani da kwayoyin T daga jinin mai bayarwa ko jinin cibiya lokaci-lokaci,. Yawancin magungunan CAR-T na atomatik ne CAR T-cell hanyoyin kwantar da hankali, wanda yawanci ya ƙunshi matakan da aka zayyana a ƙasa:
Kuna so karanta: CAR T Cell far in China
1) Ana girbe ƙwayoyin T daga jinin mai haƙuri;
2) Kwayoyin cututtuka irin su AAV sannan su gyara kwayoyin T tare da kwayoyin CAR wadanda aka tsara su akan wani takamaiman sunadaran kwayoyin halitta akan kwayoyin cutar kansa;
3) An haɓaka yawan adadin ƙwayoyin CAR-T da aka gyara bisa ga nauyin mai haƙuri;
4) Kwayoyin CAR-T da aka faɗaɗa sannan ana sake dawo dasu cikin majiyyaci. Gabaɗayan tsarin masana'anta yana ɗaukar makonni ɗaya zuwa uku kuma yana buƙatar bin GMP a cikin tsaftataccen muhalli.
Maganin CAR-T ya kai matakin nasara wanda ba a taɓa ganin irinsa ba a cikin maganin ciwon daji na B-cell wanda ke da juriya ko rashin jin daɗi ga chemotherapy, ciki har da R / R, B-ALL, NHL, da MM. Har ila yau, ana gudanar da bincike kan tasirin maganin ciwon daji. CD19-targeting da BCMA-niyyata hanyoyin kwantar da hankali na CAR-T sun sami nasara mafi girma na asibiti tsakanin duk hanyoyin kwantar da hankali na CAR-T. Hudu daga cikin hanyoyin kwantar da hankali na CAR-T shida da FDA ta yi niyyar CD19, yayin da BCMA biyu ke niyya.
Mafi mahimmancin fa'ida akan ƙananan ƙwayoyin ƙwayoyin cuta da manyan ƙwayoyin cuta shine cewa marasa lafiya na iya maye gurbin jiyya na tsawon rai na cututtukan cututtuka tare da ƙarancin adadin allurai, ko ma ɗaya kawai.
{Asar Amirka ce ta jagoranci ci gaban CAR-T masana'antu. Duk da haka, a tsakiyar shekarun 2010, kasar Sin ta koyi da sauri kuma tana kama Amurka. Ainihin, za a iya danganta manyan masu tukin jirgin sama da goyon bayan gwamnatin kasar Sin don raya tsarin muhalli na CGT wanda ya hada da kamfanonin fasahar kere-kere, da malaman jami'o'i, da masu samar da kiwon lafiya, da masu zuba jari, da gwamnati. Bayan ba da fifikon fasahar kere-kere a cikin shiri na shekaru goma sha uku na shekaru biyar, gwamnatin kasar Sin ta jaddada dabarunta na hanzarta yin kirkire-kirkire da bunkasuwar sana'o'in fasahar kere kere, gami da aikin likitancin kwayar halitta. Bugu da kari, ma'aikatun da suka dace sun fitar da ka'idojin aiki masu karfafa gwiwa.
Bayan buga Ra'ayoyin Majalisar Jiha kan Gyaran Tsarin Tattalin Arziki, Bita, da Amincewa da Magunguna da Na'urorin Lafiya a cikin 2015, kasuwar babban birnin ma ta fara aiki. A wani adadi mai girma na shekara-shekara na kashi 45 cikin 2.4, kamfanonin kula da lafiyar kwayar halitta na kasar Sin sun tara kusan dala biliyan 2018 a cikin kudade tsakanin 2021 da XNUMX.
Kuna so karanta: Farashin CAR T Cell a China
Yawan gwaje-gwajen jiyya na CAR-T a kasar Sin ya zarce na Amurka a shekarar 2018 sakamakon wannan yanayin da ake samu. Ya zuwa watan Yunin 2022, kamfanonin kasar Sin sun gudanar da gwaje-gwajen CAR-T na asibiti guda 342. Malignancies a cikin zuriyar B sun kasance daga cikin mafi yawan bayyanar cututtuka. Biyu CAR-T samfuran suna da aikace-aikacen kasuwanci: Yascarta a watan Yuni 2021 kuma Relma-cel a cikin Satumba 2021, tsakanin masu neman magani da yawa.
Dangane da Frost & Sullivan, ana hasashen kasuwar CAR-T ta cikin gida za ta haɓaka daga CNY biliyan 0.2 a cikin 2021 zuwa CNY biliyan 8 a 2025, sannan zuwa CNY biliyan 28.9 a 2030, a CAGR na 45% daga 2022 zuwa 2030. gaskiyar cewa kasuwar CAR-T ta kasar Sin har yanzu tana cikin ƙuruciyarta, akwai ƙarfin tuƙi mai ƙarfi.
Kodayake samfuran CAR-T guda biyu da aka amince da su sun fito ne daga kamfanonin haɗin gwiwar Sin da Amurka Fosun Kite da JW Terapeutics, 'yan wasan cikin gida sun sami ci gaba kuma sun kama 'yan wasan duniya a cikin 'yan shekarun nan. Legend Biotech, IASO Biotherapeutics, da CARsgen Therapeutics duk sun sami amincewar NDA don samfuran su na BCMA CAR-T, suna kafa su a matsayin jagorori a cikin maganin BCMA CAR-T. Kayayyakin CD19 CAR-T sun fi mayar da hankali ne ga Juventas Therapeutics, Gracell Biotechnologies, Hrain Biotechnology, ImunoPharm, Shanghai Cell Therapy Group, da kamfanoni na cikin gida da yawa. Juventas Therapeutics shine jagora a CD19 na kasar Sin CAR-T far Yanzu da NMPA ta karɓi NDA don CNCT19. CARsgen Therapeutics shine jagora na duniya a cikin ingantaccen ciwace-ciwacen daji, kuma CT041 shine ɗan takarar CAR-T na farko don magance ƙaƙƙarfan ciwace-ciwace don shiga Mataki na II. gwaji na asibiti. Bioheng Biotech da BRL Biotech ( Sinanci: ) suna ƙirƙirar sabbin kasuwannin CAR-T na allogeneic.
Kuna so karanta: CAR T Cell far don Multi myeloma a China
