Kamfanin Sichuan Kelun-Biotech ya ce NMPA China ta amince da allurar Cetuximab N01 don tallatawa.

A ranar 7 ga Fabrairu, 2025, Sichuan Kelun-Biotech Biopharmaceutical ta sanar da amincewa da allurar Cetuximab N01 daga Hukumar Kayayyakin Lafiya ta Kasa don maganin cutar kansar hanji (mCRC) a China.

Amincewar ta dogara ne akan wani babban bincike na asibiti na mataki na uku wanda ya nuna daidaiton maganin a cikin inganci da aminci ga magungunan da ake da su, wanda hakan na iya ƙara yawan damar yin magani ga mCRC a China inda yawan kamuwa da cutar da mace-mace ke ƙaruwa.

Binciken ya ƙunshi jimillar marasa lafiya 688, kuma sakamakon ya nuna cewa haɗin tsarin chemotherapy na cetuximab N01 ya yi daidai da na asibiti a cikin ƙimar amsawar gaskiya (ORR) idan aka kwatanta da allurar cetuximab (Erbitux) hadewar chemotherapy (ORR). Matsakaicin amsawar gaskiya (ORR) na allurar cetuximab N01 da allurar cetuximab (Erbitux) sun kasance kashi 71.0% da 77.5%, bi da bi. Babu wani bambanci mai mahimmanci a asibiti ko na ƙididdiga a cikin tsawon lokacin amsawa (DoR) da rayuwa ba tare da ci gaba ba (PFS) tsakanin allurar cetuximab N01 da allurar cetuximab (Erbitux), tare da matsakaicin rayuwa ba tare da ci gaba ba na watanni 10.9 da watanni 10.8, bi da bi.

Dangane da aminci, wannan gwaji na asibiti mai girma na mataki na uku wanda aka gudanar da shi kai-tsaye ya tabbatar da cewa haɗin tsarin chemotherapy na cetuximab N01 yana da kama da juna a cikin aminci, juriya, da kuma juriyar rigakafi idan aka kwatanta da allurar cetuximab (Erbitux) hadewar chemotherapy.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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Nassoshi

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

2.Wu CC, Hsu CW, Hsieh MC, da sauransu. Mafi kyawun Tsarin Jiyya da Tsarin Layi na Biyu ga Marasa Lafiya da ke fama da Ciwon Mara na RAS na Daji: Nazarin Meta-Analysis. J Clin Med. 4 ga Nuwamba 2021;10(21):5166.