Thaum Lub Ob Hlis 7, 2025, Sichuan Kelun-Biotech Biopharmaceutical tau tshaj tawm tias nws tau pom zoo rau nws cov tshuaj Cetuximab N01 txhaj los ntawm National Medical Products Administration rau kev kho mob qog nqaij hlav metastatic colorectal (mCRC) hauv Suav teb.
Qhov kev pom zoo no yog raws li kev tshawb fawb loj theem III uas qhia txog qhov sib npaug ntawm cov tshuaj hauv kev ua haujlwm zoo thiab kev nyab xeeb rau cov kev kho mob uas twb muaj lawm, uas yuav ua rau muaj kev nkag mus rau kev kho mob rau mCRC hauv Suav teb qhov chaw uas tus nqi ntawm kev kis tus kab mob thiab kev tuag nce siab.
Cov kev tshawb fawb no suav nrog tag nrho 688 tus neeg mob, thiab cov txiaj ntsig tau qhia tias kev kho mob chemotherapy ua ke ntawm cetuximab N01 yog sib npaug hauv kev kho mob hauv qhov nrawm teb (ORR) piv rau cetuximab txhaj tshuaj (Erbitux) ua ke chemotherapy (ORR). Qhov nrawm teb (ORR) ntawm cetuximab N01 thiab cetuximab txhaj tshuaj (Erbitux) yog 71.0% thiab 77.5%, raws li. Tsis muaj qhov sib txawv tseem ceeb hauv kev kho mob lossis kev suav lej hauv lub sijhawm teb (DoR) thiab kev ciaj sia tsis muaj kev nce qib (PFS) ntawm cetuximab N01 thiab cetuximab txhaj tshuaj (Erbitux), nrog rau qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib ntawm 10.9 lub hlis thiab 10.8 lub hlis, raws li.
Hais txog kev nyab xeeb, qhov kev sim tshuaj loj theem III no lees paub tag nrho tias kev siv tshuaj kho mob sib xyaw ua ke ntawm cetuximab N01 zoo sib xws hauv kev nyab xeeb, kev kam rau siab, thiab kev tiv thaiv kab mob piv rau kev txhaj tshuaj cetuximab (Erbitux) ua ke.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250207150842162.html
2.Wu CC, Hsu CW, Hsieh MC, thiab lwm tus. Kev Kho Mob Zoo Tshaj Plaws thiab Kab Thib Ob rau Cov Neeg Mob uas Muaj Mob Cancer Colorectal Hom Kab Mob RAS: Kev Tshawb Fawb Txog Meta. J Clin Med. 2021 Kaum Ib Hlis 4;10(21):5166.
Lub sijhawm tshaj tawm: Lub Ob Hlis-13-2025