Ngomhla wesi-7 kweyoMdumba, ngowama-2025, iSichuan Kelun-Biotech Biopharmaceutical yabhengeza ukuvunywa kweCetuximab N01 Injection yayo yiNational Medical Products Administration yokunyanga umhlaza we-colorectal osasazekayo (mCRC) eTshayina.
Olu vunyiweyo lusekelwe kuphando olukhulu lwezonyango lwesigaba sesi-3 olubonisa ukulingana kwamayeza ekusebenzeni nasekukhuselekeni kwawo kunyango olukhoyo, nto leyo enokwandisa ukufikeleleka konyango lwe-mCRC eTshayina apho izinga lokwenzeka kunye nokufa liyenyuka.
Olu phononongo luquke izigulane ezingama-688 zizonke, kwaye iziphumo zibonise ukuba irejimeni ye-chemotherapy edibeneyo ye-cetuximab N01 yayilingana ngokwezonyango kwizinga lokuphendula elijolise ngqo (ORR) xa kuthelekiswa ne-cetuximab injection (Erbitux) combined chemotherapy (ORR). Izinga lokuphendula elijolise ngqo (ORR) ye-cetuximab N01 kunye ne-cetuximab injection (Erbitux) yayiyi-71.0% kunye ne-77.5%, ngokulandelanayo. Akukho mahluko ubalulekileyo ngokwezonyango okanye ngokwezibalo kwixesha lokuphendula (DoR) kunye ne-progression free survival (PFS) phakathi kwe-cetuximab N01 kunye ne-cetuximab injection (Erbitux), kunye nokusinda okuphakathi kweenyanga ezili-10.9 kunye neenyanga ezili-10.8, ngokulandelanayo.
Ngokuphathelele ukhuseleko, olu vavanyo lweklinikhi olukhulu olulawulwa yi-phase III luqinisekisa ngokupheleleyo ukuba i-chemotherapy edibeneyo ye-cetuximab N01 iyafana ngokukhuselekileyo, ukunyamezeleka, kunye nokuqina komzimba xa kuthelekiswa ne-chemotherapy edibeneyo ye-cetuximab injection (Erbitux).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Iireferensi
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html
2.Wu CC, Hsu CW, Hsieh MC, et al. Ulandelelwano oluLungileyo kunye noNyango oluCwangcisiweyo lweSifo se-RAS Wild-Type Metastatic Colorectal Cancer: Uhlalutyo lweMeta. J Clin Med. 2021 Novemba 4;10(21):5166.
Ixesha leposi: Februwari-13-2025