▎WuXi AppTec Content Team ReportToday (August 20th),The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Qilu Pharmaceutical Co., Ltd. submittedPanitumumab InjectionMarketing application for biosimilar accepted.Panitumumab is a monoclonal antibody product targeting EGFR.
Screenshot source: CDEOfficial Website
Public information shows,Panitumumab (panitumumab, trade name Vectibix) original product byDeveloped by Amgen，Specifically targets the epidermal growth factor receptor (EGFR)The EGFR signaling pathway plays an important role in cell proliferation and migration. Many cancer cells have been found to overexpress EGFR or show excessive activation of EGFR, enabling uncontrolled growth. Panitumumab has been approved globally for various cancer indications, includingMonotherapy for tumors expressing EGFRMetastatic Colorectal Cancer (mCRC)Patients, in combination with the FOLFOX chemotherapy regimen as first-line treatmentKRAS 2mCRC patients with wild-type exonSecond-line TreatmentRASWild-type mCRC patients, etc.。According to the official website of the Chinese Clinical Trials Registry and Information Disclosure Platform, Qilu Pharmaceutical Co., Ltd.Recombinant Anti-EGFR Fully Human Monoclonal Antibody Injection (QL1203)Multiple clinical studies have been conducted, including QL1203 combined with mFOLFOX6 versus placebo combined with mFOLFOX6 treatment.RASPatients with metastatic colorectal cancer of the wild typePhase 3 clinical study on the efficacy and safety; Comparison of pharmacokinetics and safety between QL1203 and Panitumumab original product in healthy males; Study on the safety, tolerability, and pharmacokinetics of QL1203 in colorectal cancer patients.
The submission of this biosimilar for marketing approval in China marks a significant advancement in its development process.References:
[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Aug 20, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c
[2] Official Website of China Drug Clinical Trial Registration and Information Disclosure Platform. From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml
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