I-NMPA Igunyaza I-FUCASO: Ukwelashwa Kwe-Myeloma Eningi E-China

Ukwelashwa kwe-FUCASO kwe-myeloma eminingi e-China

Yabelana ngalokhu okuthunyelwe

Izinga lokuphendula eliphelele lalokhu kwelashwa komdlavuza okuguquguqukayo okubizwa nge-FUCASO ngama-96%. Ukugunyazwa kwe-NMPA kuphawula inguquko emzabalazweni waseShayina wokulwa ne-myeloma eminingi. Le bhulogi ihlola ukusebenza kahle kwalokhu kwelashwa, ukuphepha kwakho, namandla ako okuthuthukisa imiphumela yesiguli. Ngena ngaphakathi futhi ufunde kabanzi nge-FUCASO nethemba elilethayo ezigulini eziningi ze-myeloma eziphikisayo.

I-Myeloma eminingi, umdlavuza wegazi othinta amangqamuzana e-plasma, ingaba umphikisi osabekayo. Kwehlisa ukuzivikela komzimba, futhi kwenza amathambo abe buthaka, futhi, naphezu kwentuthuko, kusenzima ukuthola amakhambi esikhathi eside. I-myeloma eminingi ilinganiselwa ukuthi izothinta abantu ababalelwa ku-176,404 emhlabeni jikelele ngo-2020. 

I-Myeloma eminingi uhlobo lwesibili oluvame kakhulu lomdlavuza wegazi, ngemva kwe-lymphoma, nokho lusabhekwa njengengavamile. Kuvame kakhulu kubantu asebekhulile, kanti isilinganiso seminyaka yokuxilongwa silinganiselwa ku-70. Kodwa kukhona umsebe wethemba ngokuthuthukile. I-CAR T cell therapy eChina.

I-China's National Medical Products Administration (NMPA) isanda kugunyaza i-BCMA entsha I-CAR T cell therapy yomdlavuza eChina ebizwa nge-FUCASO, okuphawula inguquko engaba khona ekulweni nalesi sifo esiyinkimbinkimbi. Ngakho-ke, yini i-myeloma eminingi, futhi kungani i-FUCASO idala isasasa elingaka?

Ucwaningo lwakamuva lubonisa isithembiso esimangalisayo phakathi novivinyo, ngezinga lokuphendula lilonke lama-96% kanye nezinga lokuphendula eliphelele lama-74.3% elibonwe ezigulini ezibhalisiwe eziyi-103. Le bhulogi ingena ijula ​​kwisayensi engemuva kwe-FUCASO, umthelela wayo ongaba khona ezigulini ze-myeloma, kanye nethemba elilethayo empini yomhlaba wonke yokulwa nalesi sifo esiyinselele.

Ingabe izindleko eziphezulu ezihambisana nokwelashwa komdlavuza zikwenza uzizwe ugajwe imicabango engalungile?

Asikho isidingo sokukhathazeka okwengeziwe! Vele uchofoze lapha futhi uthole ukwelashwa umdlavuza mahhala e-China lokho okunikeza ithemba elisha ezigulini emhlabeni wonke.

I-CAR T cell therapy yomdlavuza eChina

Iyini I-Multiple Myeloma Disease?

I-Myeloma eminingi, evame ukubizwa ngokuthi i-plasma cell myeloma noma i-myeloma nje, ingumdlavuza wamangqamuzana e-plasma, okungamangqamuzana egazi amhlophe atholakala emnkantsheni. Amaseli e-plasma ngokuvamile akhiqiza amasosha omzimba, okungamaprotheni asiza umzimba wakho ukuba ulwe nezifo.

Amaseli e-plasma ku-myeloma eminingi akhula ngendlela engavamile futhi aphindaphindeke ngokungalawuleki. Lawa maseli e-plasma angajwayelekile aminyanisa amangqamuzana egazi anempilo emnkantsheni, okuholela ekukhiqizeni amaprotheni angama-M angajwayelekile.

Thola Izimpawu: Umhlahlandlela Ofundisayo Ngezimpawu Ezihlebayo Nezimpawu Ze-Myeloma Eningi

Umthelela We-Myeloma Eningi Emzimbeni Womuntu:

Ukulimala kwamathambo: Amaprotheni e-M namangqamuzana e-plasma angavamile angalimaza izicubu zethambo, okuholela ebuhlungu, ukuphuka, kanye ne-osteoporosis.

Izinkinga zezinso: Amaprotheni angama-M anganqwabelana ezinso futhi aphazamise ukusebenza kwawo.

I-anemia: Ukuminyana kwamangqamuzana egazi anempilo ngamaseli e-plasma angajwayelekile kungaholela ku-anemia, okubangela ukukhathala nokuphelelwa umoya.

Ukuzivikela komzimba okubuthakathaka: Amaseli e-plasma angajwayelekile awakwazi ukwakha amasosha omzimba avamile, okwenza umzimba ube sengozini yokuthola izifo.

Funda Lokhu: I-Diagnostic imaging isindisa kanjani izimpilo ku-Multiple Myeloma Battle?

Isayensi Esemuva Kwe-FUCASO Ukwelashwa Kwe-Myeloma Eningi E-China

I-FUCASO (Equecabtagene Autoleucel) ifana nokwelashwa komdlavuza oqala phansi womdlavuza oyinkimbinkimbi obizwa ngokuthi i-multiple myeloma, ikakhulukazi kubantu abanomdlavuza obuye wabuya ngemva kokwelashwa kwangaphambilini (okubuyelelwe emuva noma okuphikiswayo kwe-multiple myeloma, RRMM).

Lokhu kwelashwa okukhethekile kusebenzisa amandla esimiso somzimba sokuzivikela ezifweni ukuze silwe nomdlavuza ngendlela yomuntu siqu futhi engase yelaphe. Kulokhu kwelashwa, amaseli e-T ashintshwa ngama-receptors akhethekile abizwa ngokuthi ama-CAR (Chimeric Antigen Receptors), awenze abe njengemicibisholo eqondisiwe ekwazi ukubona futhi ihlasele izinhloso ezithile kumaseli omdlavuza. Ukwelashwa kwe-FUCASO kwe-myeloma eminingi e-China kuhlukile ngezizathu ezimbalwa ezibalulekile:

Ubuntu Ngokugcwele: Ngokungafani nezinye izindlela zokwelapha ezifanayo, i-FUCASO isebenzisa izakhi zomuntu ngokuphelele, okwenza kube mancane amathuba okuba kubangele ukwenqatshwa kanye nemiphumela engemihle.

I-BCMA-Specific: I-CAR ku-FUCASO iqondise ngokuqondile i-BCMA, iphrotheni etholakala kakhulu kumaseli e-myeloma. Lokhu kunemba kunciphisa inani lokulimala kwezicubu ezinempilo.

I-Lentivirus NjengeVector Yofuzo: Lena indlela ephumelela kakhulu yokuletha izakhi zofuzo kuma-T cell. Ivumela i-T lymphocyte ukuthi ibone futhi ibhubhise amaseli e-myeloma.

Inamandla Futhi iyaphikelela: I-FUCASO ihlolwe kabanzi futhi yatholakala iphumelela kakhulu futhi ihlala isikhathi eside ezigulini ezine-myeloma eminingi, enikeza ithemba lokuxolelwa kwesikhathi eside.

I-China's National Medical Products Administration (NMPA) isanda kunikeza ukukhanya okuluhlaza kwe-FUCASO® ukuthi kusetshenziselwe ukwelapha i-myeloma eminingi. Ngenxa yemizamo ye-Innovent Biologics kanye ne-IASO Bio, lokhu kwelashwa okufana neqhawe elikhulu manje sekuyatholakala, okumaka igxathu elikhulu lokuya phambili ekulweni nalesi sifo esiyinselele. Lokhu kwelashwa okusha kuletha umsebe omusha wethemba ngekusasa eliqhakazile.

I-FUCASO Ukwelashwa Kwe-Myeloma Eningi E-China

Futhi funda: I-Immunotherapy Ingakusiza Ukunqoba Impi Ngokumelene Ne-Myeloma Eningi!

Kwenzekani Ngesikhathi Kuvivinywa I-FUCASO Ukwelashwa Kwe-Myeloma Eningi E-China?

Ukuhlolwa komtholampilo kwe-FUMANBA-1, okwenziwa e-China, kuhlole ukusebenza kahle nokuphepha kwe-FUCASO (Equecabtagene Autoleucel) ezigulini ezine-myeloma eminingi ebuyele emuva noma ephikisayo (RRMM). Ukuhlolwa kwakuhlanganisa iziguli eziyi-103 ezithole umthamo owodwa we-FUCASO, i-CAR-T cell therapy yomdlavuza eChina.

Imiphumela yalolu cwaningo lomtholampilo ibihlaba umxhwele ngempela:

Izinga lokuphendula eliphezulu: Amaphesenti angu-96 eziguli asabela ekwelashweni, kwathi ama-74.3% athola impendulo ephelele eqinile (sCR) noma impendulo ephelele (CR), okusho ukuthi awekho amaseli omdlavuza akhonjwayo.

Impendulo esheshayo: Isikhathi esimaphakathi sokuphendula kwakuyizinsuku eziyi-16 kuphela, okubonisa umthelela osheshayo kulesi sifo.

Ukukhululwa okuhlala isikhathi eside: Ezinyangeni eziyi-12, ama-78.8% eziguli ayesengaqhubeki, okubonisa ukusebenza ngempumelelo kokwelashwa kwesikhathi eside.

Ukukhululwa okujulile: Amaphesenti angama-95 eziguli athola isifo esisele esilinganiselwe (MRD) esingenayo, okusho ukuthi bekunamaseli omdlavuza ambalwa kakhulu angatholakali.

Isebenza kahle ezigulini ezilashwe kakhulu: Ngisho neziguli ezake zithole ukwelashwa kwe-CAR-T kwangaphambili zasabela kahle, kwathi eziyi-9 zazuza i-CR nezi-5 zazuza i-sCR.

Iphrofayili yokuphepha enhle: Abantu abambalwa kuphela abahlangabezane nemiphumela engemihle emincane efana ne-cytokine release syndrome noma neurotoxicity, futhi bonke balulama kahle.

Ukuphikelela kokwelashwa: Ezinyangeni eziyi-12 nezingu-24, amaseli e-FUCASO atholakala engxenyeni enkulu yeziguli, okubonisa ukuthi kungenzeka isenzo esihlala isikhathi eside.

Le datha, eyethulwa emhlanganweni we-American Society of Clinical Oncology ngo-2023, ikhombisa isithembiso se-FUCASO njengokwelashwa okuphumelele kakhulu nokubekezelelwa kahle kwe-myeloma eminingi.

Zithini Izindleko Zokwelashwa kwe-FUCASO Kwe-Myeloma Eningi E-China?

Izindleko zokwelashwa kwe-FUCASO kwe-myeloma eminingi e-China zizungeze u-$160,000 USD. Nakuba lokhu kungase kubonakale kuyisamba esikhulu semali, kubalulekile ukwazi ukuthi lokhu kwelashwa kuyisinyathelo esibalulekile esiya phambili ekusizeni abantu abane-myeloma eminingi.

Inikeza ithuba lemiphumela ethuthukisiwe kanye nempilo engcono. Uma ucabangela lokhu kwelashwa, kuwumqondo omuhle ukuthintana nodokotela bakho noma uxhumane nathi ukuze uthole usizo lwezezimali uma ungakwazi ukukhokha izindleko zokwelashwa. 

Imali esetshenziswe kulokhu kwelashwa okusha kwe-CAR T cell e-China akukhona nje ukukhokhela ukwelashwa - kuwutshalomali ngendlela entsha nengcono yokulwa ne-myeloma eminingi.

Izibhedlela Ezingcono Kakhulu Zokwelashwa Kwe-FUCASO Kwe-Myeloma Eningi E-China

Masikusize uthole okunye okuhamba phambili izibhedlela eChina ezihlinzeka ngokwelashwa kwe-FUCASO kwe-myeloma eminingi.

Peking University Cancer Hospital

I-Peking University Cancer Hospital iyisikhungo esaziwayo esithathwa njengesinye sezikhungo zokwelapha umdlavuza eChina. Kusemaphethelweni okuqanjwa kabusha kwezokwelapha, njalo kuphusha imingcele yocwaningo lomdlavuza, ukuxilongwa, kanye nokwelapha.

Ngokuphawulekayo, iSibhedlela Somdlavuza sase-Peking University siyingqalabutho ekwelapheni kwamaseli e-CAR T, sinikeza le nketho yokwelashwa eyinkimbinkimbi ezigulini ezibhekene nezinhlobonhlobo zomdlavuza, kuhlanganise ne-myeloma eminingi.

Ngakho-ke, uma ucabangela ukwelashwa kweseli ye-CAR T ye-myeloma eminingi, lesi sibhedlela ngokungangabazeki siyisikhungo esihloniphekile okufanele sihlolwe.

Isibhedlela iShanghai Changzheng

Isibhedlela i-Changzheng, esisenkabeni ye-Shanghai, siyisibonelo esigqamile sokusebenza kahle kwezokwelapha, sihlinzeka ngemithi yokwelapha esezingeni eliphezulu njengokwelashwa kwamaseli e-CAR T ezinhlobonhlobo zomdlavuza wegazi, okuhlanganisa ne-myeloma eminingi.

Umnyango Wezempilo Wezempilo Yesibhedlela i-Changzheng uhola uhlelo lwe-CAR T cell therapy, usebenzisa iminyaka yalo yobuchwepheshe kanye nemishini ephakeme ukuze unikeze izinhlelo zokwelashwa eziqondene nawe.

Ithimba labo elizinikele lodokotela begazi, izazi ze-oncologists, nabahlengikazi basebenza ngokubambisana ukuze baqinisekise ukuthi isiguli ngasinye sithola ukunakekelwa kwekhwalithi ephezulu kulo lonke uhambo lokwelashwa.

Isibhedlela iLu-Daopei

UDkt. Lu Daopei, udokotela wegazi odumile, wasungula iSibhedlela iLu-Daopei, esizisungule njengomholi ekwelashweni nasekucwaningeni kwezifo zegazi eChina. Ngokuphawulekayo, banolwazi olunzulu ngokwelashwa kwamaseli e-CAR-T, okuhlinzeka ngale ndlela eguquguqukayo ezigulini ezilwa ne-myeloma eminingi neminye imidlavuza.

Babe ngabokuqala eShayina ukusebenzisa amaseli e-CAR-T ukwelapha i-B-cell acute lymphoblastic leukemia (B-ALL) futhi kusukela lapho benze izinqubo eziyimpumelelo ze-CAR-T ezingaphezu kuka-300 zomdlavuza wegazi ohlukahlukene.

Isibhedlela saseBeijing Gobroad Boren

Umnyango we-hematology esibhedlela sase-Beijing Gobroad Boren ugxile ekubhekaneni nokuphazamiseka kwe-hematological ngeminyaka engaphezu kwamashumi amathathu yokuhlangenwe nakho okubanzi kuzilungiselelo zangaphakathi zomtholampilo nezaselabhorethri.

Umnyango uhlinzeka ngohlu olugcwele lwezinsizakalo zokuxilonga nokwelapha izifo ezifana ne-myeloma eminingi, i-leukemia, i-lymphoma, i-thalassemia, izinkinga zokuhlangana, kanye nezimila ze-hematological.

Uma kukhulunywa ngezinketho zokwelapha, banikeza izinhlobonhlobo zokwelapha zesimila se-hematological, okuhlanganisa: i-chemotherapy, i-immunotherapy, ukwelashwa okuhlosiwe, kanye ne-radiotherapy.

Uma wena noma othandekayo ubhekene ne-myeloma eminingi, iCancerFax ilapha ukuze ikusize. Sifana nomngane onobungane osendleleni yakho eya empilweni ethuthukisiwe. 

ICancerFax isebenza nezibhedlela ezihamba phambili zomdlavuza emhlabeni wonke, okuhlanganisa no-MD Anderson, Memorial Sloan Kettering, kanye neMayo Clinic, ukusiza iziguli ezifuna imibono yesibili noma ukunakekelwa okukhethekile zithole ukufinyelela ekwelashweni kwesimanje. 

Kule minyaka eyishumi edlule, besilokhu sisiza abantu abavela emazweni angaphezu kwangu-8, futhi sikulungele ukukusekela nawe. Xhumana nathi namuhla ukuze uhlole izinketho zokwelashwa ezingcono kakhulu ze-CAR T Cell e-China futhi uqale indlela yakho yokuzizwa ungcono.

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Ngabe Ukwelashwa Okuhlosiwe Kuguqula Kangakanani Ukwelashwa Komdlavuza Okuthuthukile?

Emkhakheni we-oncology, ukuvela kokwelashwa okuhlosiwe kuye kwaguqula isimo sokwelashwa komdlavuza oseqophelweni eliphezulu. Ngokungafani ne-chemotherapy evamile, eqondisa kabanzi amangqamuzana ahlukanisa ngokushesha, ukwelashwa okuhlosiwe kuhloswe ukuhlasela amangqamuzana omdlavuza ngokukhetha kuyilapho kunciphisa umonakalo kumaseli avamile. Le ndlela enembayo yenziwa yenzeke ngokuhlonza izinguquko ezithile zamangqamuzana noma ama-biomarker ahlukile kumaseli omdlavuza. Ngokuqonda amaphrofayili amangqamuzana ezimila, izazi ze-oncologists zingakwazi ukuhlanganisa izindlela zokwelapha ezisebenza kahle kakhulu futhi ezinobuthi obuncane. Kulesi sihloko, sihlolisisa izimiso, izinhlelo zokusebenza, kanye nentuthuko yokwelapha okuhlosiwe kumdlavuza othuthukile.

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Siyakwamukela kuCancerFax!

Ukwelashwa kweseli ye-CAR T ehloselwe i-BCMA ye-myeloma eminingi e-China kubiza phakathi kuka-55,000 no-90,000 USD, kuye ngohlobo nesigaba sesifo kanye nesibhedlela esikhethiwe.

Equecabtagene Autoleucel (FUCASO), that is approved by NMPA, will cost around 250,000 USD.

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