Ma Pepeluali 7, 2025, ua hoʻolaha ʻo Sichuan Kelun-Biotech Biopharmaceutical i ka ʻāpono ʻia ʻana o kāna Cetuximab N01 Injection e ka National Medical Products Administration no ka mālama ʻana i ka maʻi ʻaʻai colorectal metastatic (mCRC) ma Kina.
Ua hoʻokumu ʻia ka ʻāpono ʻana ma kahi noiʻi lapaʻau pae III nui e hōʻike ana i ke kūlike o ka lāʻau lapaʻau ma ka pono a me ka palekana i nā lāʻau lapaʻau e kū nei, e hoʻonui ana paha i ka hiki ke loaʻa i ka lāʻau lapaʻau no mCRC ma Kina kahi e piʻi nei ka nui o ka hanana a me ka make.
Ua komo pū ka noiʻi me ka huina o 688 mau maʻi, a ua hōʻike nā hopena ua like ke ʻano chemotherapy hui pū ʻia o cetuximab N01 ma ke ʻano lapaʻau i ka helu pane pahuhopu (ORR) i hoʻohālikelike ʻia me ka cetuximab injection (Erbitux) chemotherapy hui pū ʻia (ORR). ʻO ka helu pane pahuhopu (ORR) o cetuximab N01 a me ka cetuximab injection (Erbitux) he 71.0% a me 77.5%, kēlā me kēia. ʻAʻohe ʻokoʻa koʻikoʻi ma ke ʻano lapaʻau a i ʻole ka helu helu i ka lōʻihi o ka pane (DoR) a me ke ola manuahi holomua (PFS) ma waena o cetuximab N01 a me ka cetuximab injection (Erbitux), me ka median progression free survival o 10.9 mau mahina a me 10.8 mau mahina, kēlā me kēia.
Ma ke ʻano o ka palekana, ua hōʻoia piha kēia hoʻokolohua lapaʻau nui i kāohi ʻia e ke poʻo a i ke poʻo ma ka pae III e like ka hoʻohālikelike ʻana o ka regimen chemotherapy hui pū ʻia o cetuximab N01 i ka palekana, ka hoʻomanawanui, a me ka immunogenicity i hoʻohālikelike ʻia me ka chemotherapy i hui pū ʻia me cetuximab injection (Erbitux).
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Nā Kuhikuhi
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html
2.Wu CC, Hsu CW, Hsieh MC, et al. Ka Papa Hana Kūpono a me ka Lapaʻau ʻōnaehana ʻelua o nā maʻi me ka RAS Wild-Type Metastatic Colorectal Cancer: He Meta-Analysis. J Clin Med. 2021 Nov 4;10(21):5166.
Ka manawa hoʻouna: Pepeluali-13-2025