I whiwhi a Zurletrectinib i te Arotake Matua mai i te NMPA o Haina

I te 25 o Paenga-whāwhā, 2025, i panuitia e InnoCare Pharma kua whakaaetia te arotake matua mō tana aukati pan-TRK hou, zurletrectinib (ICP-723), e te Center for Drug Evaluation (CDE) o te China National Medical Products Administration (NMPA), i whakaae ki te New Drug Application (NDA) o te zurletrectinib mō te maimoatanga o ngā tūroro he pukupuku totoka matatau kei roto ngā hononga ira NTRK. Ko te arotake matua tētahi o ngā kaupapa here matua i whakaurua e te CDE hei whakatere i te whakaaetanga rongoā.

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I roto i te whakamātautau rēhitatanga mō ngā tūroro he pukupuku totoka NTRK fusion-positive, i whakaatu a zurletrectinib i te whai huatanga tino pai me te kōtaha haumaru pai.

I mea atu a Tākuta Jasmine Cui, te kaiwhakaū, te heamana me te Tumu Whakahaere Matua o InnoCare, "E harikoa ana mātou kua whakaaetia te arotake matua mō te zurletrectinib. Kua whakaatu a Zurletrectinib i te whai huatanga tino pai me te āhua haumaru pai. E matapaetia ana ka whakaratohia e ia he kōwhiringa maimoatanga pai ake mō ngā tūroro whai mana me ngā pukupuku totoka i te wā e taea ai."

Ko te Zurletrectinib he aukati pan-TRK i whakawhanakehia e InnoCare. I whakaputa te British Journal of Cancer, he wāhanga o te hautaka pūtaiao matua a Nature, i tētahi pepa ko "Ko te Zurletrectinib he aukati TRK o te whakatupuranga e whai ake nei me te kaha o te mahi ā-roto o te angaanga ki ngā pukupuku NTRK fusion-positive me te ātete ki ngā kaihoko o te whakatupuranga tuatahi".

I roto i te pepa, i whakaatuhia e te zurletrectinib te kaha ki te whawhai ki ngā kinase TRKA, TRKB, me TRKC WT, tae atu ki ngā whakarerekētanga ātete TRKA G595R me TRKA G667C. He kaha ake te Zurletrectinib i ētahi atu aukati TRK whakatupuranga tuatahi (larotrectinib) me te whakatupuranga e whai ake nei (selitrectinib me repotrectinib) kua whakaaetia e te FDA, kua whakamatautauria rānei ki te haumanu, ki te whawhai ki te nuinga o ngā whakarerekētanga ātete aukati TRK. Waihoki, i aukati te zurletrectinib (1 mg/kg BID) i te tipu o te pukupuku i roto i ngā tauira xenograft i ahu mai i ngā pūtau NTRK fusion-positive i te horopeta 30 ngā wā iti iho i te wā e whakaritea ana ki te selitrectinib.

I whakaaturia anō e te pepa, i roto i tētahi rangahau pharmacokinetic penetrant pūnaha io matua (CNS) i roto i ngā kiore SD, i whakaatu te zurletrectinib i te kaha ake ki te uru atu ki te arai toto-roro, me te toro atu ki te roro he pai ake i te selitrectinib me te repotrectinib. Ko te pikinga o te urunga o Zurletrectinib ki te roro i whakamaoritia hoki hei whakapai ake i te mahi ārai pukupuku. I roto i tētahi tauira xenograft glioma kiore orthotopic e mau ana i te whakarerekētanga ātete TRKA G598R/G670A, i tino whakapai ake te zurletrectinib (15 mg/kg) i te oranga o ngā kiore e mau ana i ngā glioma NTRK fusion-positive, TRK-mutant (te oranga toharite = 41.5, 66.5, me te 104 rā mō te selitrectinib, repotrectinib, me te zurletrectinib; P < 0.05), e whakaatu ana i te whai huatanga pai ake ki te repotrectinib (15 mg/kg) me te selitrectinib (30 mg/kg) (P=0.0384 me te 0.0022, ia), me te kōtaha haumaru tino pai.

Ka puta ngā ira whakakotahi NTRK i roto i ngā momo pukupuku pakeke me ngā tamariki. I roto i ētahi pukupuku onge, pērā i te carcinoma repe huware, te mate pukupuku ū huna, me te fibrosarcoma pēpi, neke atu i te 90% te auau o te whakakotahi ira NTRK. E kiia ana kei te 6,500 ngā kēhi hou o ngā pukupuku totoka whakakotahi-pai NTRK ka kitea i Haina i ia tau. He nui ngā matea haumanu kāore anō kia tutuki i tēnei wāhanga nā te kore o ngā kōwhiringa maimoatanga whai hua.

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: Mei-07-2025