Ua hāʻawi ʻo NMPA i ka lāʻau lapaʻau i koho ʻia no ka B7-H3-targeted antibody-drug conjugate HS-20093 no nsNSCLC

Ma ʻApelila 17, 2025, ua hoʻolaha ʻo Hansoh Pharmaceutical ua loaʻa i ka hui ponoʻī ʻo B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 no ka injection i ka ʻae ʻia e hoʻokomo ʻia ma ke ʻano he Breakthrough-Therapy-Designated Drug e ka National Medical Products Administration (NMPA) o Kina, me ka hōʻailona i manaʻo ʻia no ka locally advanced a metastatic non-squamous non-small cell lung cancer (NSCLC) me ka ʻole o nā mutations driver, holomua a hana hou paha ma hope o ka chemotherapy platinum-based.

ʻO HS-20093 kahi ADC noiʻi i hoʻopaʻa ʻia no B7-H3 i haku ʻia me kahi antibody monoclonal anti-B7-H3 kanaka piha i hoʻopili ʻia i ka topoisomerase inhibitor (TOPOi) payload a ke hoʻomohala ʻia nei no ka mālama ʻana i ka maʻi ʻaʻai māmā, sarcoma, nā maʻi ʻaʻai poʻo a me ka ʻāʻī a me nā puʻupuʻu paʻa ʻē aʻe i nā hoʻokolohua lapaʻau he nui ma Kina, me ke kahua noiʻi kiʻekiʻe loa ʻo ia nā hoʻokolohua lapaʻau Phase Ⅲ.

Kākoʻo ʻia ka Hoʻolālā ʻana e ka ʻikepili lapaʻau mua mai ke aʻo ʻana o ARTEMIS-001. He hoʻokolohua wehe-lepili pae I kēia, he nui-kikowaena o nā maʻi he 300 a ʻoi aku e loiloi ana i ka palekana, ka hoʻomanawanui, a me ka hana anti-tumor mua i ka ʻōpū paʻa kūloko a metastatic paha (ʻo ka maʻi kanesa māmā non-smamous non-small cell holomua kūloko a metastatic paha me ka ʻole o nā mutations hoʻokele, holomua a hana hou paha ma hope o ka chemotherapy platinum-based), i mālama ʻia e Hansoh Pharma.

Ma mua, ua loaʻa iā HS-20093 ka ʻae ʻia e hoʻokomo ʻia ma ke ʻano he Breakthrough-Therapy-Designated Drug e ka NMPA no ʻelua mau hōʻailona:

·Hoʻomohala ʻia ke Kanesa Mama Liʻiliʻi o ke Keʻena Nui (ES-SCLC) ma hope o ka mālama ʻana maʻamau o ka laina mua (platinum doublet chemotherapy i hui pū ʻia me ka immuno-therapy).

ʻO Osteosarcoma i nā maʻi i holomua ma ka liʻiliʻi o ʻelua mau laina mua o ka lāʻau lapaʻau.

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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