I-Sevabertinib Ivunyelwe eShayina: Ukwelashwa Okusha Okuqondile kwe-HER2-Mutant NSCLC

Muva nje, iBayer imemezele ukuthi iNational Medical Products Administration (NMPA) yaseShayina ivumile umuthi omusha oqondiwe i-sevabertinib wokwelapha iziguli ezindala ezinomdlavuza wamaphaphu ongeyona encane (NSCLC) ongatholakali kalula endaweni noma osakazeka kalula one-HER2 (ERBB2) esebenzayo futhi oye wabhekana nokuqhubeka kwesifo okungenani ngemva kokwelashwa okukodwa kwangaphambilini.

 

Lokhu kusho ukuthi kungakhathaliseki ukuthi uvela kuliphi izwe, manje usungakwazi ukufinyelela lokhu kwelashwa okunembile okuthuthukisiwe emhlabeni wonke ngoMnyango Wezibhedlela Zamazwe Ngamazwe zaseBeijing South Region Oncology.

 

I-Sevabertinib: Ukuhlosa Ngokuqondile Izinguquko ze-HER2

 

I-Sevabertinib iyi-inhibitor entsha, yomlomo, eguquguqukayo ye-tyrosine kinase yama-molecule amancane. Ivimbela ngamandla i-HER2 eguquliwe (kufaka phakathi ukufakwa kwe-HER2 exon 20 kanye nokuguqulwa kwamaphuzu) kanye ne-EGFR. Uma kuqhathaniswa nama-TKI endabuko angaguquki, i-TKI eguquguqukayo inikeza ukuvimba kwesikhashana nokunembile kwesisulu, okuvumela ukwelashwa okulawulwayo futhi okungenzeka kunciphise imiphumela emibi yesikhathi eside.

 

Ukukhuthaza Imininingwane Yezokwelapha: Izimpendulo Ezibalulekile, Izinzuzo Ezihlala Njalo

 

Ukuvunyelwa kwe-sevabertinib kusekelwe emiphumeleni emihle evela esivivinyweni se-SOHO-01 seSigaba I/II samazwe ngamazwe esinezikhungo eziningi:

 

- Ezigulini ezazingakaze zithole ukwelashwa kwe-ADC okuqondiswe ku-HER2 ngaphambilini

Izinga lokuphendula eliqondile (ORR) lifinyelele ku-64%, kufaka phakathi izimpendulo eziphelele ezingu-2.5% kanye nezimpendulo ezingaphelele ezingu-62%. Isikhathi esimaphakathi sempendulo sasiyizinyanga ezingu-9.2.

- Ezigulini ezazike zathola ukwelashwa kwe-ADC okuqondiswe ku-HER2 ngaphambilini

I-ORR yayisengu-38%, okuhlanganisa izimpendulo eziphelele ezingu-5.5% kanye nezimpendulo ezingaphelele ezingu-33%. Isikhathi esimaphakathi sempendulo sasiyizinyanga ezi-7.

 

Iphrofayili yokuphepha iyalawuleka futhi ihambisana nemibiko yangaphambilini, inikeza isisekelo esithembekile sokwelashwa kwesikhathi eside.

 

Kungani Ukhethe UMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology SaseBeijing South Region?

 

Njengesikhungo sezokwelapha samazwe ngamazwe esigxile ekunakekelweni komdlavuza okunembile, sinikeza iziguli zomhlaba wonke:

- Ithimba lezokwelapha elisebenzisa izilimi eziningi: Izinsizakalo ngesiShayina, isiNgisi, isiRashiya, isi-Arabhu, nokuningi, okuqinisekisa ukuxhumana okungenazinkinga kulo lonke.

- Izinsizakalo zeziguli zomhlaba wonke ezitholakala endaweni eyodwa: Ukuxhumana okuzinikele kusukela ekubonisaneni okukude kanye nosizo lwe-visa yezokwelapha kuya ekudluliselweni esikhumulweni sezindiza, amalungiselelo okulaliswa esibhedlela, kanye nokulandelwa kwangemva kokwelashwa.

- Izinhlelo zokwelapha ezenzelwe wena: Ukwelashwa okuqondiswe kuwe kanye nezinhlelo zokuphatha eziphelele ngokusekelwe kuphrofayili yezakhi zofuzo zesiguli kanye nesimo saso sonke.

 

Xhumana Nathi Namuhla Ukuze Uqale Uhambo Lwakho Lwethemba

 

UMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology SaseBeijing South Region

Ucingo Lomhlaba Wonke Lweziguli: 400-880-3716

I-WeChat: 17801183037

I-imeyili:

- 100085_010@163.com

- myimmnet@163.com

 

 

Ukuphila Kwakho Kufanelwe Ukwelashwa Okungcono Kakhulu

 

Kungakhathaliseki ukuthi ufuna umugqa wokuqala wethemba noma usuvele uthuthukile ngemuva kwezindlela eziningi zokwelapha zangaphambilini, i-sevabertinib ingase inikeze ithuba lokushintsha elingakaze libonwe. UMnyango Wezibhedlela Zomhlaba Wonke waseBeijing South Region Oncology Hospital usukulungele ukukuvulela indlela eluhlaza—shayela ku-400-880-3716 manje, noma usithinte nge-WeChat noma nge-imeyili. Masikusize uxhumane nochwepheshe abaphambili, uhlole ukufaneleka, futhi uhlele uhambo lwakho lokwelashwa eShayina.

 

Ungalindi. Yonke ikholi ingaba yisiqalo esisha.

 

UMnyango Wezizwe Ngezizwe Wesibhedlela Se-Oncology SaseBeijing South Region — Ukuhlanganisa Iziguli Zomhlaba Wonke Nemithi Yokwelapha Eqondile YaseShayina.

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Isikhathi sokuthunyelwe: Ephreli-16-2026