Na Machị 21, 2025, Junshi Biosciences kwupụtara na National Medical Products Administration ("NMPA") akwadola ojiji ọgwụ ọhụrụ ọzọ ("sNDA") maka ngwaahịa ụlọ ọrụ ahụ, toripalimab, yana bevacizumab maka ọgwụgwọ mbụ nke ndị ọrịa hepatocellular carcinoma a na-apụghị ịgbanahụ ma ọ bụ metastatic metastatic ("HCC").
Nkwado NDA ọzọ dabere na data sitere na ọmụmụ HEPATORCH (NCT04723004), nke bụ ọmụmụ ihe ahụike nke usoro nke atọ nke ọtụtụ mba dị iche iche, nke a na-achịkwaghị achịkwa, nke a na-emegheghị emeghe, nke a na-achịkwa nke ọma. Prọfesọ Jia FAN, onye ọkà mmụta nke Chinese Academy of Sciences, si n'ụlọ ọgwụ Zhongshan nke jikọtara na Mahadum Fudan, jere ozi dị ka onye nyocha bụ isi. E hiwere HEPATORCH na ebe ọgwụgwọ 57 na ala China, Taiwan na Singapore nke China, a gụnyekwara ndị ọrịa 326. Ọmụmụ ihe a bu n'obi ịtụle irè na nchekwa nke toripalimab yana bevacizumab maka ọgwụgwọ mbụ nke HCC a na-apụghị ịgbanahụ ma ọ bụ nke metastatic ma e jiri ya tụnyere ọgwụgwọ nkịtị na sorafenib.
Na Septemba 2024, nsonaazụ nke ọmụmụ HEPATORCH pụtara na nnọkọ ọmụmụ nke iri abụọ na asaa nke National Clinical Oncology Conference na 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. Nsonaazụ nke ọmụmụ ihe ahụ gosiri na isi ihe ndị dị mkpa, ndụ na-enweghị ọganihu ("PFS," dabere na nyocha rediographic onwe onye) na OS, ha abụọ nwetara nsonaazụ dị mma.
HEPATORCH gosiri na ma e jiri ya tụnyere sorafenib, toripalimab na njikọta ya na bevacizumab nwere ike ịgbatị PFS na OS nke ndị ọrịa nke ukwuu, yana PFS nke etiti nke ọnwa 5.8 vs. ọnwa 4.0, belata ohere nke ọganihu ọrịa ma ọ bụ ọnwụ site na 31% (oke ihe egwu [HR] = 0.69, 95% CI: 0.525-0.913; P = 0.0086), yana OS nke etiti nke ọnwa 20.0 vs. ọnwa 14.5, ma belata ohere nke ọnwụ site na 24% (HR = 0.76, 95% CI: 0.579-0.987; P = 0.0394). Ọnụego nzaghachi ebumnuche ("ORR") nke otu toripalimab na bevacizumab dị elu nke ukwuu karịa nke otu sorafenib. ORR nke otu abụọ ahụ bụ 25.3% na 6.1%, n'otu n'otu. Ọzọkwa, ọgwụgwọ njikọta ahụ nwere ezigbo nchekwa na ndị ọrịa nwere HCC dị elu. Ụdị nsí ahụ kwekọrọ na ụdị nsí a maara nke ọma nke monotherapy nkịtị, a chọpụtaghịkwa ihe mgbaàmà nchekwa ọhụrụ.
Banyere Toripalimab
Toripalimab bụ ọgwụ mgbochi PD-1 monoclonal nke e mepụtara maka ikike ya igbochi mmekọrịta PD-1 na ligands ya, PD-L1 na PD-L2, yana ịkwalite ime ihe nnabata PD-1 (ọrụ endocytosis). Igbochi mmekọrịta PD-1 na PD-L1 na PD-L2 na-akwalite ikike sistemu ahụ ji alụso ọrịa ọgụ ịwakpo ma gbuo mkpụrụ ndụ kansa.
Junshi Biosciences emeela ihe karịrị ọmụmụ ihe gbasara toripalimab iri anọ nke ụlọ ọrụ kwadoro, nke na-ekpuchi ihe karịrị ihe ngosi iri na ise n'ụwa niile, gụnyere na China, United States, Europe na Ndịda Ọwụwa Anyanwụ Eshia. Nnwale ahụike dị mkpa na-aga n'ihu ma ọ bụ nke emechara nke na-enyocha nchekwa na irè nke toripalimab na-ekpuchi ọtụtụ ụdị etuto ahụ, gụnyere kansa nke akpa ume, nasopharynx, esophagus, afọ, eriri afọ, ara, imeju, akụrụ, na akpụkpọ ahụ.
N'ala China, toripalimab bụ ọgwụ mgbochi monoclonal mbụ nke ụlọ ọgwụ mgbochi PD-1 kwadoro maka ahịa (nke a kwadoro na China dị ka TUOYI®). Ugbu a, enwere ihe ngosi iri na otu akwadoro maka toripalimab na ala China:
melanoma a na-apụghị iwepụ ma ọ bụ nke metastatic mgbe ọ dasịrị ọgwụgwọ sistemụ nkịtị;
ọrịa kansa nasopharyngeal na-emegharị ahụ ma ọ bụ nke metastatic (NPC) mgbe ọ dara ma ọ dịkarịa ala usoro abụọ nke ọgwụgwọ sistemu gara aga;
ọrịa kansa urothelial dị elu ma ọ bụ nke metastatic nke dara ada na chemotherapy nke nwere platinum ma ọ bụ gafere n'ime ọnwa 12 nke neoadjuvant ma ọ bụ adjuvant platinum-nwere chemotherapy;
yana cisplatin na gemcitabine dị ka ọgwụgwọ mbụ maka ndị ọrịa nwere NPC na-emegharị ahụ ma ọ bụ nke na-eme ka ahụ gbawaa;
yana paclitaxel na cisplatin n'ọgwụgwọ mbụ nke ndị ọrịa nwere ọrịa kansa squamous cell esophageal nke na-adịghị ewepụ nke ọma/na-alọghachi azụ ma ọ bụ nke dị anya (ESCC);
yana pemetrexed na platinum dị ka ọgwụgwọ mbụ na mgbanwe EGFR na mgbanwe ALK na mgbanwe ALK na-adịghị mma, nke a na-apụghị iwepụ, nke dị elu n'ógbè ma ọ bụ nke na-abụghị nke squamous nke na-abụghị obere mkpụrụ ndụ kansa (NSCLC);
yana chemotherapy dị ka ọgwụgwọ mgbe a na-awa ahụ, yana monotherapy dị ka ọgwụgwọ mgbakwunye maka ọgwụgwọ ndị okenye nwere ọkwa IIIA-IIIB NSCLC nke a na-ewepụ;
yana axitinib maka ọgwụgwọ mbụ nke ndị ọrịa nwere ọrịa kansa mkpụrụ ndụ akụrụ nke na-adịghị ewepụ ihe egwu ma ọ bụ kansa mkpụrụ ndụ akụrụ nke na-agbasa (RCC);
yana etoposide tinyere platinum maka ọgwụgwọ mbụ nke kansa akpa ume obere sel (ES-SCLC) nke nwere usoro sara mbara;
yana paclitaxel maka ịgba ọgwụ (a na-ejikọta albumin) maka ọgwụgwọ mbụ nke kansa ara ugboro ugboro ma ọ bụ nke na-adịghị mma (TNBC) nke na-apụtaghachi ugboro ugboro;
yana bevacizumab maka ọgwụgwọ mbụ nke ndị ọrịa hepatocellular carcinoma (HCC) nke a na-apụghị ịgbanahụ ma ọ bụ nke metastatic.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
Email：myimmnet@163.com
Oge ozi: Maachị-27-2025