Sichuan Kelun-Biotech Akuti Cetuximab N01 Yavomerezedwa Kuti Igwiritsidwe Ntchito Pamalonda Ndi NMPA China

Pa February 7, 2025, Sichuan Kelun-Biotech Biopharmaceutical idalengeza kuvomereza kwa Cetuximab N01 Injection yake ndi National Medical Products Administration pochiza khansa ya m'matumbo yofalikira (mCRC) ku China.

Kuvomerezedwa kumeneku kwachokera pa kafukufuku wamankhwala waukulu wa gawo lachitatu womwe ukuwonetsa kufanana kwa mankhwalawa pakugwira ntchito bwino komanso chitetezo chake poyerekeza ndi mankhwala omwe alipo kale, zomwe zitha kuwonjezera mwayi wopezeka kwa chithandizo cha mCRC ku China komwe kuchuluka kwa anthu omwe amafa ndi omwe akuwadwala kukukwera.

Kafukufukuyu adaphatikizapo odwala 688, ndipo zotsatira zake zidawonetsa kuti njira yophatikizana ya chemotherapy ya cetuximab N01 inali yofanana ndi yachipatala mu objective response rate (ORR) poyerekeza ndi cetuximab injection (Erbitux) combined chemotherapy (ORR). Objective response rate (ORR) ya cetuximab N01 ndi cetuximab injection (Erbitux) inali 71.0% ndi 77.5%, motsatana. Panalibe kusiyana kwakukulu pakati pa nthawi yoyankha (DoR) ndi progression free survival (PFS) pakati pa cetuximab N01 ndi cetuximab injection (Erbitux), ndi apakatikati a progression free survival a miyezi 10.9 ndi miyezi 10.8, motsatana.

Ponena za chitetezo, mayeso azachipatala akuluakulu a gawo lachitatu awa akutsimikizira mokwanira kuti njira yophatikizana ya chemotherapy ya cetuximab N01 ndi yofanana pachitetezo, kulekerera, komanso chitetezo cha mthupi poyerekeza ndi chemotherapy yophatikizana ya cetuximab jakisoni (Erbitux).

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Email：myimmnet@163.com

Zolemba

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

2. Wu CC, Hsu CW, Hsieh MC, ndi ena. Kutsatana Kwabwino Kwambiri ndi Chithandizo Chachiwiri Chadongosolo cha Odwala Omwe Ali ndi RAS Wild-Type Metastatic Colorectal Cancer: Kusanthula kwa Meta. J Clin Med. 2021 Nov 4;10(21):5166.