Thaum Lub Plaub Hlis 17, 2025, Hansoh Pharmaceutical tshaj tawm tias Pawg Neeg tus kheej tsim B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 rau kev txhaj tshuaj tau txais kev pom zoo kom suav nrog ua Breakthrough-Therapy-Designated Drug los ntawm National Medical Products Administration (NMPA) ntawm Tuam Tshoj, nrog rau qhov kev qhia rau kev mob qog nqaij hlav hauv zos lossis metastatic non-squamous non-small cell lung cancer (NSCLC) uas tsis muaj kev hloov pauv tsav tsheb, nce qib lossis rov tshwm sim tom qab platinum-based chemotherapy.
HS-20093 yog ib qho ADC uas tsom mus rau B7-H3 uas tab tom tshawb nrhiav uas muaj cov tshuaj antibody monoclonal antibody uas txuas nrog topoisomerase inhibitor (TOPOi) payload thiab tab tom tsim los kho mob qog noj ntshav ntsws, sarcoma, qog noj ntshav taub hau thiab caj dab thiab lwm yam qog nqaij hlav hauv ntau qhov kev sim tshuaj hauv Suav teb, nrog rau theem kev tshawb fawb siab tshaj plaws yog Theem III kev sim tshuaj.
Lub Npe tau txais kev txhawb nqa los ntawm cov ntaub ntawv kho mob ua ntej los ntawm kev tshawb fawb ARTEMIS-001. Qhov no yog theem I qhib-daim ntawv lo, ntau lub chaw sim ntawm ntau dua 300 tus neeg mob soj ntsuam kev nyab xeeb, kev kam rau siab, thiab kev ua haujlwm tiv thaiv qog nqaij hlav hauv cov qog nqaij hlav khov kho hauv zos lossis metastatic (qog nqaij hlav hauv zos lossis metastatic non-squamous non-small cell ntsws tsis muaj kev hloov pauv tsav tsheb, nce qib lossis rov tshwm sim tom qab platinum-based chemotherapy), ua los ntawm Hansoh Pharma.
Yav dhau los, HS-20093 tau txais kev pom zoo kom suav nrog ua Tshuaj Kho Mob Tshiab los ntawm NMPA rau ob qho cim qhia:
Mob Cancer Ntsws Me Me (ES-SCLC) uas loj hlob tom qab kev kho mob thawj kab (platinum doublet chemotherapy ua ke nrog kev kho mob immunotherapy).
· Osteosarcoma rau cov neeg mob uas tau nce qib ntawm tsawg kawg yog ob txoj kev kho mob yav dhau los.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Plaub Hlis-22-2025