Ngomhlaka-25 kuNhlolanja 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-finotonlimab ngokuhlanganiswa ne-SCT510.ukwelashwa kwe-carcinoma yesibindi engasuswa noma esakazeke kakhulu engakatholi ukwelashwa kwesistimu ngaphambilini.
I-Finotonlimab iyi-antibody ye-monoclonal ye-IgG4 ephinde yahlanganiswa futhi enamalungelo aphelele empahla yobuhlakani. Njengomuthi omusha onelungelo lobunikazi, isakhiwo sayo sama-molecule sihlukile futhi sinezinzuzo zendlela yokusebenza. I-Finotonlimab ibopha i-PD-1 ngokuqina okuphezulu, ivimba ngempumelelo indlela ye-PD-1/PD-L1, ibuyisele futhi ithuthukise umsebenzi wokubulala amasosha omzimba wamaseli e-T, ngaleyo ndlela ivimbele ukukhula kwesimila.
Emhlanganweni Waminyaka Yonke we-ASCO ka-2024, kubika i-isivivinyo sesigaba sesi-3 esingahleliwe of I-SCT-I10A ihlanganiswe ne-bevacizumab biosimilar (SCT510) uma iqhathaniswa ne-sorafenib ekwelashweni kokuqala kwe-carcinoma yesibindi ethuthukisiwe.
Kulolu vivinyo lwesigaba sesi-3 oluvulekile, olunezikhungo eziningi, (i-NCT04560894) olwenziwa eShayina, iziguli ezine-HCC ethuthukisiwe ezazingazange zithole ukwelashwa kwesistimu ngaphambilini zabhaliswa futhi zabelwa ngokungahleliwe (2:1) ukuthola i-SCT-I10A (200 mg njalo emavikini amathathu [Q3W]) kanye ne-SCT510 (i-bevacizumab biosimilar, 15 mg/kg Q3W) noma i-sorafenib (400 mg ngomlomo kabili ngosuku) kuze kube yilapho kungekho nzuzo yezokwelapha noma ubuthi obungamukeleki. Ukungahleliwe kwahlukaniswa ngokwesimo sokusebenza kwe-ECOG (0 vs. 1), izinga le-alpha-fetoprotein eliyisisekelo (<400ng/ml vs. ≥400ng/ml), ukuhlasela kwe-macrovascular noma i-metastasis yangaphandle kwesibindi (yebo vs. cha). Iziphetho eziyinhloko ezihambisanayo kwakuyi-overall survival (OS) kanye ne-progressive-free survival (PFS) njengoba kuhlolwe yi-blindless independent central review (BICR) ngokusho kwe-Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 kusethi ephelele yokuhlaziya.
Ngesikhathi sokuhlolwa kwedatha kwesikhashana (ngoNovemba 2, 2023), iziguli ezingu-346 zibhalisiwe futhi zathola okungenani umthamo owodwa (iqembu le-SCT-I10A kanye ne-SCT510, n=230; iqembu le-sorafenib, n=116), kanti ukulandelwa okuphakathi kwaba yizinyanga ezingu-19.7. Iqembu le-SCT-I10A kanye ne-SCT510 libonise i-OS ephakathi ende kakhulu kunaleyo eqenjini le-sorafenib (izinyanga ezingu-22.1 vs. 14.2, isilinganiso sengozi [HR] 0.60; isikhawu sokuzethemba esingu-95% [CI]: 0.44, 0.81; p=0.0008). I-Median PFS yaqhubeka isikhathi eside kakhulu eqenjini le-SCT-I10A kanye ne-SCT510 uma kuqhathaniswa neqembu le-sorafenib (izinyanga ezingu-7.1 vs. 2.9; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). Izinga lokuphendula eliqondile (ORR) laliphezulu eqenjini le-SCT-I10A kanye ne-SCT510 (32.8% [75/229]) kunaseqenjini le-sorafenib (4.3% [5/116]). Izehlakalo ezimbi ezihlobene nokwelashwa (ama-TRAE) zebanga ≥3 zabonwa ku-42.6% (98/230) weziguli eqenjini le-SCT-I10A kanye ne-SCT510 kanye no-33.6% (39/116) weziguli eqenjini le-sorafenib. Ibanga elivame kakhulu le-≥3 TRAE kwakuyi-hypertension (iqembu le-SCT-I10A kanye neqembu le-SCT510 uma kuqhathaniswa neqembu le-sorafenib: 7.8% [18/230] uma kuqhathaniswa ne-4.3% [5/116]). Ukufa okuthathu okuhlobene nezidakamizwa (imbangela engaziwa, ukopha ngaphakathi kobuchopho, noma ukopha okuphezulu kwesisu esigulini esisodwa ngasinye) kwenzeke futhi kwakuhlobene ne-SCT510.
Iziphetho: Inhlanganisela ye-SCT-I10A kanye ne-SCT510 ibonise izinzuzo ezinkulu zezokwelapha kanye nephrofayili yokuphepha eyamukelekayo ezigulini ezine-HCC ethuthukisiwe, ngaleyo ndlela isekela ukufaneleka kwayo njengenketho yokwelashwa yokuqala ye-HCC.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Mashi-10-2025