I-China Inika Unyango Oluphuhlileyo Ilungelo Lokutyunjwa kwi-ZL-1310: I-DLL3-Targeting ADC Entsha Ene-86% Esebenzayo kwi-Brain Metastases

Ngomhla wesi-9 kuFebruwari, ngo-2026, iwebhusayithi esemthethweni yeZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) yabhengeza ukuba i-ZL-1310 yokujova, i-DLL3-target antibody-drug conjugate (ADC) entsha, icwangciselwe ukunikwa iBreakthrough Therapy Designation.

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Njengelungu lePeking University Cancer Hospital Medical Consortium kunye nesibhedlele esikhethekileyo sesibini se-oncology sanamhlanje saseBeijing, iSebe le-Beijing South Region Oncology Hospital International lisebenzisa iqonga eliqinileyo lokuxilongwa kunye nonyango olubandakanya iinkalo ezahlukeneyo ukuze lidibanise ngokukhawuleza unyango oluphambili kwihlabathi liphela kwizicwangciso zonyango lwezigulane zamazwe ngamazwe. Ukuba wena okanye umntu omthandayo ujongene nemingeni yonyango lwesibini okanye oluzayo lomhlaza wemiphunga weeseli ezincinci, nceda ufunde ngononophelo idatha engezantsi kwaye unxibelelane nathi ngoko nangoko.

Nxibelelana neSebe leMicimbi yeHlabathi leSibhedlele i-Oncology saseBeijing South Region ngoku:

- Ifowuni: 400-880-3716

- I-ID ye-WeChat: 17801183037

- Email ①: 100085_010@163.com

- Email ②: myimmnet@163.com

**Idatha Engacacanga: Ukusebenza kakuhle ukuya kuthi ga kwi-86% kwizigulana ezineMetastases yobuchopho**

KwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ka-2025, idatha yesifundo seklinikhi sesigaba se-1a/1b sehlabathi se-ZL-1310 yavezwa.

Kwabaguli abafumene unyango ngaphambili (unyango lodidi lwesibini):

- Izinga lokuphendula ngendlela echanekileyo (uORR) elingaqinisekiswanga lifikelele kwi-67%, kunye nezinga lokulawula isifo (DCR) le-97%.

- Kwiqela ledosi efanelekileyo yebhayoloji (1.6 mg/kg): Izinga lokuphendula elijoliswe kwinjongo (ORR) linyuke laya kwi-79%, kunye nezinga lokulawula isifo (DCR) le-100%.

- Oku kuthetha ukuba: Phantse zonke izigulane ezili-10 ezifumene le dosi zifikelele kwinqanaba lokulawula ithumba, kwaye phantse izigulane ezisi-8 ziye zancipha kakhulu ithumba.

Kwabona bantu banengxaki enkulu yokuphazamiseka kwengqondo:

- Izigulane ezine-baseline brain metastases: Izinga lokuphendula kwinjongo (ORR) yayiyi-68%.

- Izigulana ezingazange zifumane unyango lwe-cranial radiotherapy: Izinga lokuphendula ngendlela ejolise kwi-objective response (ORR) laliphezulu njenge-86%!

Olu lwazi luyamangalisa. Amayeza e-chemotherapy emveli ayasokola ukungena kumqobo wegazi-ubuchopho, kodwa i-ZL-1310 ibonisa umsebenzi oqinileyo wokulwa nomhlaza ngaphakathi kwentloko. Kwizigulane zamazwe ngamazwe ezixhalabele iziphumo ebezingalindelekanga zonyango lwe-radiotherapy yobuchopho obupheleleyo, oku kubonisa ithemba elikhulu "lokuphepha imitha yobuchopho."

 

**Iprofayili yoKhuseleko:** Kwiqela ledosi elingaphantsi kwe-2.0 mg/kg, izehlo zeziganeko ezingalunganga ezinxulumene nonyango (ii-TRAE) zebanga lesi-3 okanye ngaphezulu yayiyi-6% kuphela, kungekho ziganeko zesifo semiphunga esinxulumene nonyango (i-ILD) okanye zokuyekiswa konyango ezixeliweyo.

**III. Kutheni Ukhetha iSebe leMicimbi yeHlabathi leSibhedlele se-Oncology saseBeijing South Region?**

Kwizigulane zamazwe ngamazwe, ukufikelela kunyango olutsha akupheleli nje ekubeni “iyeza likhona na,” kodwa kukwakho nenkqubo ecwangcisiweyo ebandakanya “ukuba ngubani onokulisebenzisa, indlela yokulisebenzisa, kunye nokuba ngubani olawula iziphumo ebezingalindelekanga.”

ISebe leMicimbi yeHlabathi leSibhedlele i-Oncology saseBeijing South Region libonelela ngovavanyo olunokwenzeka kunye nolawulo olupheleleyo lwezonyango ezisemgangathweni ezifana ne-ZL-1310 kwizigulane ezifanelekileyo. Nokuba uvela eMzantsi-mpuma Asia, kuMbindi Mpuma, eYurophu, okanye eMelika, sinenkqubo yenkonzo yezonyango yamazwe ngamazwe esele imiselwe kakuhle.

Sinikezela ngeenkonzo ezibanzi, ukusuka kwiingcebiso zangaphambi kokuba uye esibhedlele, ukuguqulela kwiilwimi ezininzi, iileta ze-visa zonyango, ukuya kulandelelo lonyango. Ukunamathela ngokungqongqo kumgaqo-nkqubo othi “ugqirha omnye, isigulane esinye, igumbi elinye” kuqinisekisa ukuba ubumfihlo bakho kunye nesidima sakho ziyahlonitshwa ngokupheleleyo, nokuba ukwilizwe langaphandle.

Okwangoku, i-ZL-1310 inikwe i-Orphan Drug Advisory kunye ne-Fast Track Designation yi-US FDA. Ukufakwa kwayo okucwangcisiweyo kwi-Breakthrough Therapy Designation yaseTshayina kuya kukhawulezisa kakhulu ukufikeleleka kwayo eTshayina.

Musa ukuvumela imiqobo yolwimi, izikhewu zolwazi, okanye iinkqubo ezinzima zikuthintele ekufumaneni unyango oluphambili. ISebe leMicimbi yeHlabathi leSibhedlele saseBeijing South Region Oncology liseke ijelo eliluhlaza lezigulane zamazwe ngamazwe.

Thabatha ifowuni okanye unxibelelane nathi nge-WeChat okanye nge-imeyile ukuze wabelane ngemeko yakho. Iingcali zethu zonyango ziya kubonelela ngovavanyo lokuqala zingadlulanga iiyure ezingama-24.

- Umnxeba (ingcebiso enikezelwa iiyure ezingama-24): 400-880-3716

- I-WeChat (unxibelelwano olukhawulezileyo): 17801183037 (ixhasa isiNgesi nesiTshayina)

- I-imeyile (yeerekhodi zonyango):

- 100085_010@163.com

- myimmnet@163.com

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Ixesha lokuthumela: Februwari-12-2026