Drug intelligence / Profile preview

HLX05

Development stage
Approved
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Intramuscular
01

Overview

HLX05 is a **biosimilar** to **cetuximab**, a chimeric monoclonal antibody that targets the **epidermal growth factor receptor (EGFR)**. It acts as an **EGFR antagonist**, inhibiting signal transduction pathways involved in cell proliferation and survival, which are frequently activated in various cancers. HLX05 is being developed primarily for oncology indications, mirroring the therapeutic uses of cetuximab, such as metastatic colorectal cancer and squamous cell carcinoma of the head and neck. HLX05 is being developed by Shanghai Henlius Biotech and is currently in early-stage clinical trials to assess its pharmacokinetics, safety, tolerability, and immunogenicity compared to the reference product, Erbitux (cetuximab)[1][3][5][9].

Brand names
HLX05HLX-05HLX 05
Other names
Anti-EGFR monoclonal antibody 225 biosimilar重组抗EGFR人鼠嵌合单克隆抗体(上海复宏汉霖生物)
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)

Beyond the preview

Go deeper on HLX05.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on HLX05.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call