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A Randomized, Double-blind, Parallel Control, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of HLX04 and Bevacizumab Combined With Oxaliplatin and Fluoropyrimidine-based Chemotherapy (XELOX or mFOLFOX6) in the First-line Treatment of Metastatic Colorectal Cancer (mCRC)

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Trial Profile

A Randomized, Double-blind, Parallel Control, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of HLX04 and Bevacizumab Combined With Oxaliplatin and Fluoropyrimidine-based Chemotherapy (XELOX or mFOLFOX6) in the First-line Treatment of Metastatic Colorectal Cancer (mCRC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2026

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At a glance

  • Drugs Bevacizumab (Primary) ; Capecitabine; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Shanghai Henlius Biotech

Most Recent Events

  • 13 Jan 2026 According to a Shanghai Henlius Biotech media release, company announced that the Biologics License Application (BLA) for HLX04 has been formally accepted for review by the U.S. Food and Drug Administration (FDA). The application seeks approval for the treatment of multiple solid tumours, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.
  • 19 Feb 2025 According to a Henlius Biopharmaceuticals media release, the company has received approval form Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED) for marketing HANBEITAI in Bolivia under the trade name LONGIVA Bolivia is mainly based on the review of a series of data.
  • 17 Jan 2022 Planned End Date changed from 30 Apr 2021 to 30 Apr 2024.

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