Ngo-Ephreli 17, 2025, i-Hansoh Pharmaceutical imemezela ukuthi i-B7-H3-target antibody-drug conjugate (ADC) HS-20093 yeQembu eyazikhiqizela yona ukuze ijovwe ithole imvume yokufakwa njengoMuthi Oqokiwe Wokwelapha yi-National Medical Products Administration (NMPA) yaseShayina, kanye nesibonakaliso esiphakanyisiwe somdlavuza wamaphaphu ongeyona i-squamous non-small cell (NSCLC) othuthukisiwe noma osakazeke endaweni ngaphandle kokuguqulwa komshayeli, waqhubeka noma waphindeka ngemuva kwe-chemotherapy esekelwe ku-platinum.
I-HS-20093 iyi-ADC ehlosiwe ye-B7-H3 ephenyweni eyakhiwe yi-antibody ye-anti-B7-H3 monoclonal yomuntu ehlanganiswe ndawonye ne-topoisomerase inhibitor (TOPOi) payload futhi yakhelwe ukwelapha umdlavuza wamaphaphu, i-sarcoma, umdlavuza wekhanda nentamo kanye nezinye izimila eziqinile ezivivinyweni eziningi zemitholampilo eShayina, kanti isigaba socwaningo esiphezulu kakhulu yizivivinyo zemitholampilo zeSigaba Ⅲ.
I-Designation isekelwa idatha yomtholampilo yokuqala evela ocwaningweni lwe-ARTEMIS-001. Lolu wuvivinyo oluqhubekayo lwesigaba sokuqala oluvulekile, olunezikhungo eziningi lweziguli ezingaphezu kuka-300 oluhlola ukuphepha, ukubekezeleleka, kanye nomsebenzi wokuqala wokulwa nomdlavuza esimilaneni esiqinile esithuthukisiwe noma esisakazekile endaweni (umdlavuza wamaphaphu ongeyona i-squamous non-small cell osakazekile endaweni ethile noma osakazekile ngaphandle kokuguqulwa komshayeli, oqhubeke noma ophinde wavela ngemuva kwe-chemotherapy esekelwe ku-platinum), olwenziwa yi-Hansoh Pharma.
Ngaphambilini, i-HS-20093 ithole imvume yokufakwa njengomuthi oqokiwe yi-NMPA njenge-Breakthrough-Therapy ngezinkomba ezimbili:
·Umdlavuza Wamaphaphu Wesigaba Esibanzi Wamangqamuzana Amancane (i-ES-SCLC) wavela ngemuva kokwelashwa okujwayelekile komugqa wokuqala (i-chemotherapy ye-platinum doublet ehlanganiswe nokwelashwa nge-immuno-therapy).
·I-Osteosarcoma ezigulini eseziqhubekele phambili okungenani emigqeni emibili yokwelashwa ngaphambilini.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Ephreli-22-2025