Hoʻolaha ʻo Junshi Biosciences i ka ʻae ʻia ʻana o sNDA no Toripalimab i hui pū ʻia me Bevacizumab no ka mālama ʻana i ka laina mua o ka maʻi kanesa Hepatocellular holomua

Ma Malaki 21, 2025, ua hoʻolaha ʻo Junshi Biosciences ua ʻāpono ka National Medical Products Administration (“NMPA”) i ka noi lāʻau lapaʻau hou (“sNDA”) no ka huahana a ka hui, ʻo toripalimab, i hui pū ʻia me bevacizumab no ka mālama mua ʻana i nā maʻi hepatocellular carcinoma (“HCC”) hiki ʻole ke hoʻopau ʻia a i ʻole ka metastatic.

Hoʻokumu ʻia ka ʻae ʻana o ka NDA pākuʻi ma ka ʻikepili mai ke aʻo ʻana o HEPATORCH (NCT04723004), he haʻawina lapaʻau multi-center, randomized, open-label, active-controlled phase 3 multinational. ʻO Polofesa Jia FAN, he academician o ka Chinese Academy of Sciences, mai ka Halemai Zhongshan e pili ana i ke Kulanui ʻo Fudan, i lawelawe ma ke ʻano he mea noiʻi nui. Ua hoʻomaka ʻia ʻo HEPATORCH ma 57 mau kikowaena lapaʻau ma ka ʻāina nui o Kina, ʻo Taiwan a me Singapore o Kina, a ua kākau inoa ʻia he 326 mau maʻi. ʻO ka manaʻo o ke aʻo ʻana e loiloi i ka pono a me ka palekana o ka toripalimab i hui pū ʻia me bevacizumab no ka lāʻau lapaʻau laina mua o ka HCC hiki ʻole ke hoʻopau ʻia a metastatic paha i hoʻohālikelike ʻia me ka lāʻau lapaʻau maʻamau me sorafenib.

I Kepakemapa 2024, ua hoʻomaka mua ʻia nā hopena o ke aʻo ʻana ʻo HEPATORCH ma ka 27th National Clinical Oncology Conference a me ka 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. Ua hōʻike nā hopena o ke aʻo ʻana ua loaʻa i nā hopena mua, ʻo ke ola ʻole me ka holomua ʻole ("PFS," ma muli o ka loiloi radiographic kūʻokoʻa) a me OS, nā hopena maikaʻi.

Ua hōʻike ʻo HEPATORCH i ka hoʻohālikelike ʻana me ka sorafenib, hiki i ka toripalimab i hui pū ʻia me bevacizumab ke hoʻonui nui i ka PFS a me ka OS o nā maʻi, me ka PFS waena o 5.8 mau mahina vs. 4.0 mau mahina, e hōʻemi i ka pilikia o ka holomua o ka maʻi a i ʻole ka make ma 31% (lakio pōpilikia [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), me ka OS waena o 20.0 mau mahina vs. 14.5 mau mahina, a e hōʻemi i ka pilikia o ka make ma 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). ʻOi aku ka kiʻekiʻe o ka helu pane pahuhopu ("ORR") o ka hui toripalimab a me bevacizumab ma mua o ka hui sorafenib. ʻO ka ORR o nā hui ʻelua he 25.3% a me 6.1%, kēlā me kēia. Eia kekahi, he ʻano palekana maikaʻi ko ka hui pū ʻana i nā maʻi me ka HCC holomua. Kūlike ka spectrum toxicity me ka spectrum toxicity i ʻike ʻia o ka monotherapy maʻamau, a ʻaʻohe hōʻailona palekana hou i ʻike ʻia.

E pili ana iā Toripalimab

ʻO Toripalimab kahi antibody monoclonal anti-PD-1 i hoʻomohala ʻia no kona hiki ke ālai i nā pilina PD-1 me kāna mau ligands, PD-L1 a me PD-L2, a e hoʻoulu i ka internalization o ka receptor PD-1 (hana endocytosis). ʻO ka ālai ʻana i nā pilina PD-1 me PD-L1 a me PD-L2 e hoʻolaha i ka hiki o ka ʻōnaehana pale e hoʻouka a pepehi i nā cell tumor.

Ua mālama ʻia ma mua o kanahā mau haʻawina lapaʻau toripalimab i kākoʻo ʻia e ka hui e uhi ana i nā hōʻailona he ʻumikumamālima ma ka honua holoʻokoʻa e Junshi Biosciences, me Kina, ʻAmelika Hui Pū ʻIa, ʻEulopa a me Asia Hikina Hema. ʻO nā hoʻokolohua lapaʻau koʻikoʻi e hoʻomau nei a i hoʻopau ʻia paha e loiloi ana i ka palekana a me ka pono o ka toripalimab e uhi ana i nā ʻano ʻano puʻupuʻu like ʻole, me nā maʻi kanesa o ka māmā, nasopharynx, esophagus, ʻōpū, mimi ʻōpū, umauma, akepaʻa, puʻupaʻa, a me ka ʻili.

Ma ka ʻāina nui o Kina, ʻo toripalimab ka antibody monoclonal anti-PD-1 kūloko mua i ʻāpono ʻia no ke kūʻai aku ʻana (i ʻāpono ʻia ma Kina ʻo TUOYI®). I kēia manawa, aia he ʻumikumamākahi mau hōʻailona i ʻāpono ʻia no toripalimab ma ka ʻāina nui o Kina:

melanoma hiki ʻole ke hoʻopau ʻia a metastatic paha ma hope o ka hāʻule ʻole o ka lāʻau lapaʻau maʻamau;

ka carcinoma nasopharyngeal recurrent a metastatic paha (NPC) ma hope o ka hāʻule ʻana o ʻelua mau laina o ka lāʻau lapaʻau mua;

ʻO ka carcinoma urothelial holomua a metastatic paha i hāʻule i ka chemotherapy platinum-containing a i ʻole i holomua i loko o 12 mau mahina o ka chemotherapy neoadjuvant a i ʻole adjuvant platinum-containing;

i ka hui pū ʻana me cisplatin a me gemcitabine ma ke ʻano he lāʻau lapaʻau mua no nā maʻi me ka NPC kūloko a metastatic paha;

i ka hui pū ʻana me ka paclitaxel a me cisplatin i ka lāʻau lapaʻau mua o nā maʻi me ka carcinoma squamous cell esophageal metastatic locally advanced/recurrent a mamao paha (ESCC) hiki ʻole ke hoʻopau ʻia;

i ka hui pū ʻana me ka pemetrexed a me ka platinum ma ke ʻano he lāʻau lapaʻau mua ma ka EGFR mutation-negative a me ka ALK mutation-negative, unresectable, locally advanced a metastatic non-squamous non-small cell lung cancer (NSCLC);

i ka hui pū ʻana me ka chemotherapy ma ke ʻano he lāʻau perioperative a ma hope me ka monotherapy ma ke ʻano he adjuvant therapy no ka mālama ʻana i nā maʻi makua me ka pae resectable IIIA-IIIB NSCLC;

i ka hui pū ʻana me axitinib no ka mālama mua ʻana i nā maʻi me ka maʻi renal cell carcinoma (RCC) hiki ʻole ke hoʻokaʻawale ʻia a i ʻole ka metastatic;

i hui pū ʻia me ka etoposide me ka platinum no ka lāʻau lapaʻau mua o ka maʻi kanesa māmā liʻiliʻi ākea (ES-SCLC);

i ka hui pū ʻana me ka paclitaxel no ka injection (albumin-bound) no ka lāʻau lapaʻau mua o ka maʻi ʻaʻai umauma triple-negative recurrent a metastatic paha (TNBC);

i ka hui pū ʻana me bevacizumab no ka mālama mua ʻana i nā maʻi hepatocellular carcinoma (HCC) hiki ʻole ke hoʻopau ʻia a metastatic paha.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

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