Ka Tukuna e te CDE te Whakaaetanga IND ki te Whakaora EpCAM CAR-T a Immunofoco mō te Tohu Tuarua

I te 21 o Poutū-te-rangi, 2025, i panuitia e Immunofoco kua whakaaetia tana rongoā pūtau CAR-T autologous EpCAM-targeting motuhake, IMC001, e te Center for Drug Evaluation (CDE) i raro i te National Medical Products Administration (NMPA) i Haina mō tana tono tuarua mō te Rongoā Rangahau Hou (IND), me te nama whakaae CXSL2400901. Ko te whāinga o tēnei tono IND he rongoā i ngā pukupuku totoka matatau epithelial EpCAM-positive. I mua, i whiwhi a IMC001 i ngā whakaaetanga IND i Haina me te United States i te Hui-tanguru 2024 mō te rongoā i ngā pukupuku puku matatau EpCAM-positive.

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He nui te whakaaturanga o te ngota piri pūtau epithelial (EpCAM) i runga i ngā kiko pukupuku epithelial, tae atu ki te mate pukupuku korokoro, te mate pukupuku colorectal, te mate pukupuku pancreatic, te mate pukupuku ovarian, te mate pukupuku pūkahukahu, te mate pukupuku puku, me te mate pukupuku ū. He rerekē, he iti noa iho tōna whakaaturanga i roto i ngā kiko noa. Ahakoa ngā wero pēnei i te uaua o te taiao moroiti pukupuku totoka me te rerekētanga o te ūnga, kua whakaatuhia e IMC001 te haumaru pai me te whai huatanga tuatahi i roto i ngā whakamātautau haumanu o mua mō ngā pukupuku gastrointestinal, nā tana whiringa ūnga ahurei me te hoahoa auaha. Ko te whāinga o tēnei tohu tāpiri he tūhura atu i tōna pūmanawa haumanu.

I roto i ngā whakaaturanga pānui i ngā huihuinga ASCO me CSCO o te tau 2024, i whakaatuhia e ngā raraunga rangahau haumanu IIT o IMC001, i roto i ngā tūroro 10 e taea te arotake me te mate pukupuku puku kua whanake, ko te reiti whakahaere mate he 90%, kotahi te tūroro i roto i te rōpū horopeta iti 33.3% me te tokorua i roto i te rōpū horopeta waenga 40% i eke ki te urupare hapa (PR). Ko te oranga whānui toharite (OS) i roto i te rōpū horopeta waenga neke atu i te 55 wiki. Kotahi te tūroro i roto i te rōpū horopeta waenga i eke ki te PR kua whakaūtia i te Wiki 24, ā, i arahina ki te tango gastrectomy radical i te Wiki 27, ā, kua ora te tūroro mō te neke atu i te 22 marama i te rā kati.

Ko te whakakorenga o tēnei IND tāpiri he tohu nui ki te whakawhānui ake i te whānuitanga o te tūhuratanga haumanu a IMC001 mai i ngā pukupuku gastrointestinal ki tētahi whānuitanga whānui o ngā pukupuku totoka epithelial, tae atu ki te mate pukupuku pūkahukahu pūtau-iti (SCLC), te mate pukupuku ū triple-negative (TNBC), me ētahi atu mate pukupuku.

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-03-2025