E ai ki a Sichuan Kelun-Biotech kua whakaaetia te Werohanga Cetuximab N01 mō te hokohoko e NMPA Haina

I te 7 o Pēpuere, 2025, i whakapuakina e Sichuan Kelun-Biotech Biopharmaceutical te whakaaetanga o tana Werohanga Cetuximab N01 e te National Medical Products Administration mō te rongoā i te mate pukupuku colorectal metastatic (mCRC) i Haina.

Ko te whakaaetanga i ahu mai i tētahi rangahau haumanu wāhanga tuatoru nui e whakaatu ana i te ōritetanga o te whai huatanga me te haumaru o te rongoā ki ngā maimoatanga o nāianei, ā, ka piki ake pea te urunga atu ki te maimoatanga mō te mCRC i Haina kei te piki haere te auau me te mate.

I whakaurua te katoa o ngā tūroro ki te rangahau, ā, i whakaatuhia e ngā hua ko te tikanga rongoā chemotherapy whakakotahi o te cetuximab N01 he rite tonu ki te reiti urupare whāinga (ORR) ki te werohanga cetuximab (Erbitux) chemotherapy whakakotahi (ORR). Ko te reiti urupare whāinga (ORR) o te cetuximab N01 me te werohanga cetuximab (Erbitux) he 71.0% me te 77.5%, ia. Kāore he rerekētanga haumanu, tatauranga rānei i roto i te roa o te urupare (DoR) me te oranga kore-haere-ake (PFS) i waenga i te cetuximab N01 me te werohanga cetuximab (Erbitux), me te oranga kore-haere-ake toharite o te 10.9 marama me te 10.8 marama, ia.

Mō te haumaru, e whakaū ana tēnei whakamātautau haumanu wāhanga III, kanohi ki te kanohi, he rite tonu te haumaru, te manawanui, me te kaha ārai mate o te cetuximab N01 ki te werohanga cetuximab (Erbitux) i roto i te maimoatanga chemotherapy.

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.

Tau Waea：4008803716

Email：myimmnet@163.com

Ngā Tohutoro

1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html

2.Wu CC, Hsu CW, Hsieh MC, et al. Te Raupapa Tino Pai me te Maimoatanga Pūnaha Tuarua-Raina o ngā Tūroro me te Matepukupuku Metastatic Colorectal RAS Mohoao: He Tātaritanga-Meta. J Clin Med. 2021 Whiringa-ā-rangi 4;10(21):5166.