I te 21 o Poutū-te-rangi, 2025, i panuitia e Junshi Biosciences kua whakaaetia e te National Medical Products Administration (“NMPA”) te tono rongoā hou tāpiri (“sNDA”) mō te hua a te kamupene, te toripalimab, me te bevacizumab hei rongoā tuatahi mō ngā tūroro hepatocellular carcinoma (“HCC”) kāore e taea te tango, te hunga rānei kua horapa te mate pukupuku.
Ko te whakaaetanga tāpiri NDA e ahu mai ana i ngā raraunga mai i te rangahau HEPATORCH (NCT04723004), he rangahau haumanu wāhanga 3 matapōkere maha-pokapū, matapōkere, tuwhera-tapanga, whakahaere-kaha. Ko Ahorangi Jia FAN, he tohunga mātauranga o te Chinese Academy of Sciences, mai i te Hōhipera Zhongshan e hono ana ki te Whare Wānanga o Fudan, te kairangahau matua. I whakarewahia a HEPATORCH i roto i te 57 pokapū haumanu i te tuawhenua o Haina, Taiwan me Singapore o Haina, ā, e 326 ngā tūroro i whakaurua. Ko te whāinga o te rangahau he aromatawai i te whai huatanga me te haumaru o te toripalimab me te bevacizumab mō te maimoatanga raina tuatahi o te HCC kāore e taea te tango, te HCC metastatic rānei, ki te whakataurite ki te maimoatanga paerewa me te sorafenib.
I te marama o Hepetema 2024, i puta tuatahi ngā hua o te rangahau HEPATORCH i te 27 o ngā Huihuinga ā-Motu mō te Mate Pūkahukahu Hauora me te Hui-ā-Tau Mātauranga a te Rōpū Hainamana mō te Mate Pūkahukahu Hauora (CSCO) i te tau 2024. I whakaatuhia e ngā hua o te rangahau ko ngā pito matua, ko te oranga kore-haere whakamua ("PFS," i runga i te arotakenga X-ray motuhake) me te OS, i eke ki ngā hua pai.
I whakaatuhia e HEPATORCH, ki te whakaritea ki te sorafenib, ka taea e te toripalimab me te bevacizumab te whakaroa ake i te PFS me te OS o ngā tūroro, me te PFS toharite o te 5.8 marama vs. 4.0 marama, te whakaiti i te mōrearea o te whanaketanga o te mate, te mate rānei mā te 31% (ōwehenga mōrearea [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), me te OS toharite o te 20.0 marama vs. 14.5 marama, me te whakaiti i te mōrearea o te mate mā te 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). Ko te reiti urupare whāinga (“ORR”) o te rōpū toripalimab me te bevacizumab he nui ake i te rōpū sorafenib. Ko te ORR o ngā rōpū e rua he 25.3% me te 6.1%, ia. Hei tāpiritanga, he pai te āhua haumaru o te rongoā whakakotahi mō ngā tūroro he HCC matatau. He rite tonu te whānuitanga paitini ki te whānuitanga paitini e mōhiotia ana o te rongoā kotahi paerewa, ā, kāore he tohu haumaru hou i kitea.
Mō Toripalimab
Ko te Toripalimab he paturopi monoclonal anti-PD-1 i whakawhanakehia mō tōna kaha ki te aukati i ngā taunekeneke PD-1 me ōna ligands, PD-L1 me PD-L2, me te whakaoho i te whakaurunga o te kaiwhakawhiwhi PD-1 (te mahi endocytosis). Mā te aukati i ngā taunekeneke PD-1 me PD-L1 me PD-L2 ka whakatairanga i te kaha o te pūnaha ārai mate ki te whakaeke me te patu i ngā pūtau pukupuku.
Neke atu i te whā tekau ngā rangahau haumanu toripalimab i tautokona e te kamupene e kapi ana i te neke atu i te tekau mā rima ngā tohu kua whakahaerehia puta noa i te ao e Junshi Biosciences, tae atu ki Haina, Te Hononga o Amerika, Ūropi me te Tonga-mā-rāwhiti o Āhia. Ko ngā whakamātautau haumanu matua e haere tonu ana, e oti rānei, e aromatawai ana i te haumaru me te whai huatanga o te toripalimab e kapi ana i te whānuitanga o ngā momo pukupuku, tae atu ki ngā mate pukupuku o te pukahukahu, te ihu o te ihu, te korokoro, te puku, te pūkahukahu, te ū, te ate, te whatukuhu, me te kiri.
I te tuawhenua o Haina, ko te toripalimab te paturopi monoclonal anti-PD-1 tuatahi o te motu i whakaaetia mō te hokohoko (i whakaaetia i Haina ko TUOYI®). I tēnei wā, tekau mā tahi ngā tohu kua whakaaetia mō te toripalimab i te tuawhenua o Haina:
melanoma kāore e taea te tango, te horapa rānei i muri i te korenga o te rongoā pūnaha paerewa;
te mate pukupuku ihu (NPC) e hokihoki mai ana, e horapa ana rānei i muri i te korenga o te rua o ngā momo rongoā pūnaha o mua;
te mate pukupuku urothelial kua horapa ki te rohe, kua horapa rānei, ā, i rahua te chemotherapy kei roto he platinum, i ahu whakamua rānei i roto i ngā marama 12 o te chemotherapy neoadjuvant, adjuvant rānei kei roto he platinum;
me te whakamahi tahi me te cisplatin me te gemcitabine hei rongoā tuatahi mō ngā tūroro e pāngia ana e te NPC e hokihoki ana ki te rohe, e horapa ana rānei;
hei rongoā tuatahi mō ngā tūroro e pangia ana e te mate pukupuku pūtau squamous esophageal kua horapa ā-rohe/hoki mai, kua horapa rānei ki tawhiti;
i te taha o te pemetrexed me te platinum hei maimoatanga tuatahi mō te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kāore i te whai i te whakarerekētanga EGFR me te mate pukupuku pūkahukahu ALK kāore i te whai i te whakarerekētanga ALK, kāore e taea te tango, kua whanake ā-rohe, kua horapa rānei;
hei tāpiritanga ki te chemotherapy hei maimoatanga i mua i te pokanga, ā, muri iho ka whakamahia hei monotherapy hei rongoā tāpiri mō ngā tūroro pakeke me te wāhanga IIIA-IIIB NSCLC ka taea te tango;
hei rongoā tahi me te axitinib mō te maimoatanga tuatahi o ngā tūroro he mate pukupuku pūtau tākihi (RCC) kāore e taea te tango, he mate pukupuku pūtau tākihi rānei e horapa ana;
hei tāpiritanga ki te etoposide me te platinum mō te maimoatanga tuatahi o te mate pukupuku pūkahukahu iti wāhanga whānui (ES-SCLC);
hei tāpiri atu ki te paclitaxel hei werohanga (herea ki te albumin) hei rongoā tuatahi mō te mate pukupuku ū toru-kino e hokihoki mai ana, e horapa mai ana rānei (TNBC);
hei rongoā tuatahi mō ngā tūroro hepatocellular carcinoma (HCC) kāore e taea te tango, te hunga rānei kua horapa te mate pukupuku hepatocellular (HCC).
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Wā tuku: Maehe-27-2025