Ukuqokwa Kwe-GFH375 Kwezokwelapha Okuphumelelayo eShayina: Isinyathelo Esithembisayo Sokuqhubekela Phambili Komdlavuza We-Pancreatic We-KRAS G12D-Mutant Metastatic

NgoMashi 31, 2026, i-Center for Drug Evaluation of China's National Medical Products Administration ilethe izindaba ezijabulisayo: I-GFH375, eyasungulwa yi-GenFleet Therapeutics, ifakiwe ngokusemthethweni njengomuntu ofanele "ukwelashwa okuphumelelayo" ekwelapheni iziguli ezinomdlavuza we-pancreatic osabalele i-KRAS G12D mutation ezithole okungenani ukwelashwa okukodwa kwangaphambilini. Lokhu kuphawula isinyathelo esibalulekile phambili emkhakheni wokwelashwa okunembile komdlavuza we-pancreatic.

Uma wena noma othandekayo wakho nibhekene nomdlavuza we-pancreatic oguquliwe we-KRAS G12D, ningalahli ithemba. UMnyango Wezizwe Ngezizwe Wesibhedlela i-Beijing South Region Oncology Hospital (400-880-3716) ulandela eduze lolu hlelo olusezingeni eliphezulu futhi unikeza izinsizakalo zokubonisana kochwepheshe kanye nokuxhumanisa ukwelashwa kweziguli zakwamanye amazwe.

**Mayelana ne-GFH375/VS-7375**

I-GFH375 iyisivimbeli se-KRAS G12D (ON/OFF) esisebenza ngomlomo, esinamandla, futhi esikhetha kakhulu i-KRAS G12D (ON/OFF) esiklanyelwe ukubhekisa ukushintshaniswa kwe-GTP/GDP, ngaleyo ndlela siphazamise ukusebenza kwendlela engezansi futhi sivimbele ngempumelelo ukwanda kwamaseli esimila. Izifundo zangaphambi kokwelashwa zibonise ukuvinjelwa okuncike kumthamo kumamodeli anezinguquko ze-KRAS G12D; i-GFH375 iphinde yabonisa ingozi ephansi ngaphandle kwenhloso ekukhetheni kwe-kinase kanye nokuhlolwa kokuphepha kwenhloso.

I-GenFleet yangena ekubambisaneni kokutholwa nokuthuthukiswa ne-Verastem Oncology (Nasdaq: VSTM) ukuze ithuthukise izinhlelo ezintathu ezintsha ze-oncology ezihlose umdlavuza oqhutshwa yi-RAS/MAPK. Lokhu kubambisana kunikeza i-Verastem inketho ekhethekile yokuthola ilayisensi yamakhemikhali amathathu ngemva kokuphothula ngempumelelo izinyathelo ezibekiwe esivivinyweni seSigaba I. NgoDisemba 2023, i-Verastem yakhetha i-GFH375/VS-7375, i-KRAS G12D (ON/OFF) inhibitor yomlomo, njengohlelo lwayo oluholayo kusukela ekubambisaneni, kanti ilayisensi ye-GFH375 eyasetshenziswa ngoJanuwari 2025 yayingowokuqala kusukela kulokhu kubambisana. Amalayisense anikeza i-Verastem amalungelo okuthuthukiswa kanye nokuhweba ngaphandle kwe-China, kuyilapho i-GenFleet igcina amalungelo ngaphakathi kwe-China.

**Idatha yesilingo somtholampilo esithembisayo seSigaba I/II eyethulwe eNgqungqutheleni ye-ESMO ka-2025:**

- Iziguli ezingama-91.5% zathola ukwehla kwezilonda eziqondiwe

- Izinga lokuphendula okuhlosiwe (ORR) lifinyelele ku-40.7%

- Izinga lokulawula izifo (i-DCR) laliphezulu kakhulu lifinyelela ku-96.7%

- Ukusinda okungenalo inqubekela phambili okumaphakathi (mPFS) kwakuyizinyanga ezingu-5.52

- Izinga lokusinda elingenayo inqubekela phambili yezinyanga ezine lalingu-78.2%

Le datha, ethathwe ezigulini ezingu-59 ezine-KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC) ethuthukisiwe ezake zathola ukwelashwa kwesistimu ngaphambilini, ikhombisa ngokunamandla umsebenzi onamandla wokulwa nomdlavuza we-GFH375 kumdlavuza we-pancreatic ongaphikisi.

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

Njengephayona kwezokwelapha zomhlaba wonke, uMnyango Wezokwelapha Wesibhedlela Samazwe Ngamazwe saseBeijing South Region Oncology uzibophezele ekuhlinzekeni iziguli zomhlaba wonke nge:

- Izinsizakalo zokubonisana kwezokwelapha zobungcweti kanye nezokuqokwa kwezilimi eziningi

- Ukufinyelela kochwepheshe abaphambili be-oncology eShayina nakwamanye amazwe

- Isiteshi esiluhlaza esisodwa sokwelashwa kwezokwelapha okuwela umngcele

Siyaqonda ukuthi ezigulini ezinomdlavuza osezingeni eliphezulu, usuku ngalunye lokulinda luletha ingozi enkulu. Ngakho-ke, sisungule iziteshi eziningi zokuxhumana zamazwe ngamazwe ezilula ukuqinisekisa ukuthi uthola ukwesekwa kochwepheshe ngesikhathi esifanele.

**Xhumana nathi namuhla bese uqala uhambo lwakho lwethemba**

���� Ucingo oluphuthumayo: 400-880-3716

���� I-WeChat: 17801183037

���� I-imeyili:

- 100085_010@163.com

- myimmnet@163.com

Kungakhathaliseki ukuthi ukuliphi izwe noma isifunda, noma ukuthi zingaki izindlela zokwelapha osuzizamile, uMnyango Wezangaphandle Wesibhedlela Se-Beijing South Region Oncology ukulungele ukukusiza ekulweni kwakho nomdlavuza. Intuthuko eqhubekayo ye-GFH375 ingaba ukukhanya obekulokhu ukulindele.

Call 400-880-3716, add us on WeChat at 17801183037, or email us at 100085_010@163.com or myimmnet@163.com.

Sisonke, masilwele amathuba engeziwe okuphila.

> Qaphela: I-GFH375 ayikavunyelwa ngokusemthethweni ukumaketha ezwenikazi laseShayina. Ukuqokwa kwayo kwe-Breakthrough Therapy kulindeleke ukuthi kusheshise ukufinyeleleka kwezokwelapha. UMnyango Wezizwe Ngezizwe Wesibhedlela SaseBeijing South Region Oncology uzoqapha eduze intuthuko ekufinyeleleni kwemithi futhi unikeze ulwazi mayelana nokwelashwa okuseqophelweni eliphezulu kanye nezinsizakalo zokuxhumanisa iziguli ezifanelekile. Sicela ulandele isiqondiso sikadokotela wakho mayelana nezinhlelo ezithile zokwelapha.

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Isikhathi sokuthunyelwe: Ephreli-10-2026