Sichuan Kelun-Biotech avuga ko inshinge za Cetuximab N01 zemewe ku isoko na NMPA Ubushinwa

Ku ya 7 Gashyantare 2025, Sichuan Kelun-Biotech Biopharmaceutical yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (National Medical Products Agency) cyemeye inshinge za Cetuximab N01 mu kuvura kanseri y’inkondo y’umura (mCRC) mu Bushinwa.

Kwemeza gushingiye ku bushakashatsi bwakozwe mu cyiciro cya gatatu cy’ubuvuzi bw’icyiciro cya gatatu bwerekana ko uyu muti ungana mu mikorere n’umutekano ugereranije n’ubuvuzi busanzwe, bishobora kongera uburyo bwo kuvura mCRC mu Bushinwa aho umubare w’abandura n’impfu ziyongera.

Ubushakashatsi bwakozwe ku barwayi 688, kandi ibyavuye mu bushakashatsi byagaragaje ko uburyo bwo gufata imiti ya cetuximab N01 buvanze bwari bungana mu buryo bufatika mu gipimo cy’ubutabazi (ORR) ugereranije n’uburyo bwo gufata imiti ya cetuximab injection (Erbitux) injection (ORR). Igipimo cy’ubutabazi (ORR) cya cetuximab N01 na cetuximab injection (Erbitux) byari 71.0% na 77.5%, uko bikurikirana. Nta tandukaniro rigaragara mu buvuzi cyangwa mu mibare mu gihe cyo gufata imiti (DoR) no kubaho nta guhindagurika (PFS) hagati ya cetuximab N01 na cetuximab injection (Erbitux), aho hagati y’amezi 10.9 n’amezi 10.8, uko bikurikirana.

Ku bijyanye n'umutekano, iki cyiciro cya gatatu cy'igerageza rinini ryakozwe ku rwego rwo hejuru ryemeza neza ko uburyo bwo gufata imiti ya cetuximab N01 buvanze bwa cetuximab bungana mu mutekano, kwihanganira no kutagira ubudahangarwa bw'umubiri ugereranije n'uburyo imiti ya cetuximab iterwa (Erbitux) iterwa na cetuximab.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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Amareferensi

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

2. Wu CC, Hsu CW, Hsieh MC, n'abandi. Uburyo bwiza bwo kuvura abarwayi ba RAS Kanseri y'uruhu isanzwe: Isesengura rya Meta. J Clin Med. 2021 Ugushyingo 4; 10 (21): 5166.