Kua Whakamanahia e te NMPA te Rongoā Whakaora-Whanui mō te B7-H3-targeted Antibody-Drug Conjugate HS-20093 mō ngā nsNSCLC

I te 17 o Paenga-whāwhā, 2025, ka pānuitia e Hansoh Pharmaceutical kua whakaaetia te werohanga HS-20093 i hangaia e te Rōpū hei rongoā Breakthrough-Therapy-Designated e te National Medical Products Administration (NMPA) o Haina, me te tohu kua whakaarohia mō te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua whanake ā-rohe, kua horapa rānei, kāore he whakarerekētanga taraiwa, kua ahu whakamua, kua hoki mai rānei i muri i te chemotherapy e hangai ana ki te platinum.

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Ko te HS-20093 he ADC rangahau e arohia ana ki te B7-H3, he mea tito mai i tētahi paturopi monoclonal anti-B7-H3 tangata katoa e hono tahi ana ki te kawenga aukati topoisomerase (TOPOi), ā, kei te whakawhanakehia mō te rongoā i te mate pukupuku pūkahukahu, te sarcoma, ngā mate pukupuku o te upoko me te kaki me ētahi atu pukupuku totoka i roto i ngā whakamātautau haumanu maha i Haina, ko te wāhanga rangahau teitei rawa ko ngā whakamātautau haumanu Wāhanga Ⅲ.

E tautokona ana te Tohunga e ngā raraunga haumanu tuatahi mai i te rangahau ARTEMIS-001. He whakamātautau tuwhera-tapanga wāhanga I tēnei, he whakamātautau maha-pokapū kei te haere tonu, neke atu i te 300 ngā tūroro e aromatawai ana i te haumaru, te manawanui, me te mahi ārai-puku tuatahi i roto i te pukupuku totoka kua horapa, kua horapa rānei (mate pukupuku pūkahukahu kore-pūtau iti kua horapa, kua horapa rānei, kāore he whakarerekētanga taraiwa, kua ahu whakamua, kua hoki anō rānei i muri i te chemotherapy e hangai ana ki te platinum), i whakahaerehia e Hansoh Pharma.

 

I mua, kua whakaaetia a HS-20093 kia whakaurua hei rongoā Breakthrough-Therapy-Designated Drug e te NMPA mō ngā tohu e rua:

·Ka puta te matepukupuku pūkahukahu iti o te wāhanga whānui (ES-SCLC) i muri i te maimoatanga tuatahi (te rongoā platinum takirua me te rongoā ārai mate).

·Te Osteosarcoma i roto i ngā tūroro kua whanake haere i muri i te rua o ngā rongoā o mua.

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: Paenga-whāwhā-22-2025