Sichuan Kelun-Biotech o re Cetuximab N01 E Amohetsoe Papatso ke NMPA China

Ka la 7 Hlakola 2025, Sichuan Kelun-Biotech Biopharmaceutical e phatlalalitse tumello ea Cetuximab N01 Ente ea eona ke Tsamaiso ea Naha ea Lihlahisoa tsa Bongaka bakeng sa kalafo ea kankere ea mala a maholo (mCRC) e metastatic Chaena.

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Kamohelo ena e ipapisitse le phuputso e kgolo ya bongaka ya mokgahlelo wa III e bontshang ho lekana ha moriana ka katleho le polokeho le diphekolo tse seng di ntse di le teng, e leng se ka eketsang phihlello ya kalafo bakeng sa mCRC Chaena moo sekgahla sa ho ata le ho shwa se ntseng se eketseha.

Phuputso ena e ne e kenyeletsa bakuli ba 688 kaofela, 'me liphetho li bontšitse hore mokhoa oa chemotherapy o kopantsoeng oa cetuximab N01 o ne o lekana ka bongaka ka sekhahla sa karabelo ea sepheo (ORR) ha o bapisoa le cetuximab injection (Erbitux) combined chemotherapy (ORR). Sekhahla sa karabelo ea sepheo (ORR) sa cetuximab N01 le cetuximab injection (Erbitux) e ne e le 71.0% le 77.5%, ka ho latellana. Ho ne ho se na phapang ea kliniki kapa ea bohlokoa ea nako ea karabelo (DoR) le progression free survival (PFS) pakeng tsa cetuximab N01 le cetuximab injection (Erbitux), ka karolelano ea ho phela ntle le tsoelo-pele ea likhoeli tse 10.9 le likhoeli tse 10.8, ka ho latellana.

Mabapi le polokeho, teko ena ea bongaka e kholo ea mohato oa III e laoloang ke hlooho le hlooho e tiisa ka botlalo hore mokhoa oa chemotherapy o kopaneng oa cetuximab N01 o ts'oana ka polokeho, mamello le ho itšireletsa mafung ha o bapisoa le chemotherapy e kopantsoeng ea cetuximab ente (Erbitux).

Hona jwale, ho ntse ho na le diteko tse ngata tsa bongaka tsa mahlale a matjha a ho lwantsha kankere Chaena a batlang bakudi. Dipuisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.

Nomoro ea mohala: 4008803716

Email:myimmnet@163.com

Litšupiso

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

2.Wu CC, Hsu CW, Hsieh MC, jj. Tatellano e Molemohali le Kalafo ea Mokhoa oa Bobeli ea Bakuli ba nang le RAS Kankere ea Metastatic Colorectal ea Mofuta oa Tlhaho: Tlhahlobo ea Meta. J Clin Med. 2021 Pulungoana 4;10(21):5166.

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Nako ea poso: Hlakola-13-2025