Ngomhlaka-15 Disemba 2025, i-National Medical Products Administration yaseShayina yagunyaza ngokusemthethweni ukwethulwa kwemakethe komuthi omusha wokulwa nomdlavuza i-zurletrectinib (ICP-723). Le ntuthuko ephawulekayo iletha ithemba lokwelapha elingakaze libonwe ezigulini emhlabeni wonke ezinezimila eziqinile ezinezakhi zofuzo ze-NTRK fusion.
**Ukwelashwa Okuguquliwe “Kwesifo Sokungezwani Nezimila”: Intuthuko Yesayensi Ye-Zurletrectinib**
I-Zurletrectinib iyisidakamizwa sokuqala se-TRK esithuthukiswe ngokuzimela eShayina, esenzelwe ngqo iziguli ezinezimila eziqinile ezithuthukile noma ezisakazeke endaweni ethile eziqukethe izakhi zofuzo ze-Neurotrophic Tyrosine Receptor Kinase (NTRK). Lo muthi "ongaqapheli" wokulwa nomdlavuza we-broad-spectrum umele ushintsho olujwayelekile emkhakheni wokwelashwa komdlavuza—ukuguquka kusuka ekuhlukanisweni nasekuphathweni okusekelwe endaweni yendabuko okusekelwe kuyo kanye nokwelashwa kuya ekwelashweni okuqondiswe ngokunemba okusekelwe ekushintsheni kwezakhi zofuzo.
**Izinkomba Eziyinhloko:**
* Iziguli ezitholakale ngokuhlolwa okuqinisekiswe ngokugcwele njengeziphethe i-gene ye-NTRK fusion (ngaphandle kokuguqulwa kokumelana okutholakale okwaziwayo).
* Iziguli zabantu abadala kanye nentsha (ezineminyaka engu-12 nangaphezulu) ezinezimila eziqinile ezingenayo enye indlela yokwelapha eyanelisayo noma eziye zahluleka ukwelashwa kwazo kwangaphambilini.
**Inzuzo Eyinhloko:**
Uma nje i-gene ye-NTRK fusion itholakala ngokuhlolwa kwezakhi zofuzo, iziguli zingase zizuze kakhulu ekwelashweni nge-zurletrectinib, kungakhathaliseki ukuthi isimila sivela emaphashini, e-thyroid, emabeleni, emathunjini amancane, noma kwezinye izindawo.
**Idatha Evelele Yezokwelapha: Ukuchaza Kabusha Okulindelwe Kokwelashwa**
Ukuhlolwa kwezokwelapha kwe-zurletrectinib okwenziwe eShayina kubonise idatha ephumelelayo yokusebenza kahle, okunikeza ithemba elikhulu lokusinda kweziguli ezinezimila eziqinile ezithuthukile:
* **Izinga Lokuphendula Lilonke (ORR): 89.1%** — Cishe ama-90% eziguli abhekane nokuncipha okukhulu kwesimila.
* **Izinga Lokulawula Izifo (DCR): 96.4%** — Ukuqhubeka kwesifo kwalawulwa ngempumelelo cishe kuzo zonke iziguli.
* **Isilinganiso Sokusinda Okungadingi Ukuqhubekela Phambili Kwezinyanga Ezingama-24 (i-PFS): 77.4%** — Ukulawulwa kwesikhathi eside kokuqhubekela phambili kwesifo.
* **Isilinganiso Sokusinda Sezinyanga Ezingama-24 (OS): 90.8%** — Isikhathi sokusinda sesiguli eside kakhulu.
**UMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology SaseBeijing South Region: Indlela Yakho Yokwelapha Umdlavuza Osezingeni Eliphezulu**
UMnyango Wezangaphandle Wesibhedlela i-Beijing South Region Oncology Hospital uzibophezele ekuhlinzekeni iziguli zomhlaba wonke ukufinyelela izixazululo zokwelapha umdlavuza ezithuthukisiwe. Ithimba lethu lezokwelapha lomhlaba wonke lizinikele ekunikezeni ukwesekwa kwezokwelapha okuphelele nokwenziwe ngokwezifiso kuzo zonke iziguli zomhlaba wonke.
Izinsizakalo zethu ezikhethekile zifaka:
1. Ukubonisana nokuhlolwa kokwelashwa kweziguli emhlabeni jikelele.
2. Ukuhlelwa kanye nokuchazwa kokuhlolwa kwezakhi zofuzo ze-NTRK fusion.
3. Ukubonisana kochwepheshe bemikhakha eminingi kanye nokuhlela ukwelashwa okuphelele.
4. Ukuhumusha kwezokwelapha ngezilimi eziningi kanye nokusekelwa kokuzivumelanisa namasiko.
**Xhumana noMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology saseBeijing South Region**
Siyaqonda ubunzima nezinselele iziguli zakwamanye amazwe ezibhekana nazo lapho zifuna ukunakekelwa kwezokwelapha kwamanye amazwe. Ngakho-ke, sisungule iziteshi zokuxhumana ezilula nezihlukahlukene ukuqinisekisa ukuthi ungafinyelela kalula ulwazi lwezokwelapha olugunyaziwe futhi uqale inqubo yokwelashwa.
**Indlela Yokuxhumana Ekhethwayo:**
* Ucingo Lokuphuthumayo Lweziguli Zamazwe Ngamazwe: 400-880-3716
**Iziteshi Zokuxhumana Ezihlukahlukene:**
* Ukubonisana nge-WeChat: Engeza i-ID ethi “17801183037″ ukuze uthole ukubonisana okusekelwe emilayezweni kanye nezimpendulo ezisheshayo.
* Ukubonisana nge-imeyili:
* General Inquiry: 100085_010@163.com
* International Medical Exclusive: myimmnet@163.com
**Inqubo Yesiguli Yomhlaba Wonke:**
1. Xhumana noMxhumanisi Weziguli Zomhlaba Wonke nganoma iyiphi yalezi zindlela ezingenhla.
2. Thumela amarekhodi ezokwelapha ukuze ahlolwe kuqala (kufaka phakathi imibiko yezifo, imiphumela yokuhlolwa kwezakhi zofuzo, njll.).
3. Hlela ukubonisana ngevidiyo kude nochwepheshe we-oncology wamazwe ngamazwe.
4. Uma kudingeka ukwelashwa eShayina, sizosiza ngokucubungula i-visa yezokwelapha, amalungiselelo okuhlala, kanye nokunye ukuthutha.
5. Jabulela izinsizakalo zezokwelapha ezifika kanye kuphela lapho ufika eBeijing, kusukela ekuthathweni esikhumulweni sezindiza kuya kulo lonke uhambo lokwelashwa.
**Isikhumbuzo Esibalulekile: Ukuhlolwa Kwezakhi Zofuzo Ngaphambi Kokwelashwa Kubalulekile**
Njengomuthi oqondiwe, ukusebenza kahle kwe-zurletrectinib kuncike kakhulu ekuhlolweni okunembile kwezakhi zofuzo. Sincoma ukuthi zonke iziguli ezicabangela lokhu kwelashwa ziqale zihlolwe izakhi zofuzo ze-NTRK. UMnyango Wezangaphandle Wesibhedlela SaseBeijing South Region Oncology ungakuhlelela izinsizakalo zokuhlola eziqashelwa emhlabeni wonke noma unikeze incazelo enegunya yemiphumela yakho yokuhlolwa ekhona.
**Ukubheka Phambili: Isikhathi Esisha Sokwelashwa Komdlavuza Okwenziwe Ngokwezifiso**
Ukuvunyelwa kwe-zurletrectinib akukhona nje ukwethulwa komuthi omusha; kuwubufakazi obunamandla bamakhono eShayina ekwelapheni umdlavuza ngendlela enembile. UMnyango Wezizwe Ngezizwe Wesibhedlela SaseBeijing South Region Oncology uzoqhubeka nokulandela intuthuko yomhlaba wonke ekwelapheni umdlavuza, uhlanganise izinsiza zezokwelapha ezisezingeni eliphezulu ezivela emithonjeni yasekhaya neyamazwe ngamazwe, futhi unikeze izinsizakalo zokuxilongwa nokwelashwa komdlavuza ezigxile esigulini ezisezingeni lomhlaba ezigulini zamazwe ngamazwe.
**Shayela manje ukuze ubuze ukuthi wena noma othandekayo wakho ningabaphi abantu abazongenela lolu hlelo olusha lokwelapha!**
Inombolo Yocingo Yeziguli Zamazwe Ngamazwe YaseBeijing South Region Oncology Hospital International Department: 400-880-3716
I-ID ye-WeChat: 17801183037
Email: 100085_010@163.com; myimmnet@163.com
**Qaphela:** Ulwazi lwezokwelapha olukulesi sihloko lusekelwe kudatha yokuhlolwa kwezokwelapha etholakala emphakathini. Izinhlelo zokwelapha ezithile kumele zakhiwe odokotela abangochwepheshe ngokusekelwe ezimweni zesiguli ngasinye. Kunconywa ukuthi zonke iziguli zithintane nochwepheshe bezempilo abafanelekayo ngaphambi kokucabangela noma yikuphi ukwelashwa.
Isikhathi sokuthunyelwe: Disemba 31-2025