Drug intelligence / Profile preview

donafenib + KN046

Development stage
Unknown
Lead developer
Suzhou Zelgen Biopharmaceuticals
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

Donafenib + KN046 is a **combination therapy** consisting of donafenib, a small molecule multi-kinase inhibitor, and KN046, a recombinant humanized bispecific antibody targeting PD-L1 and CTLA-4. Donafenib inhibits multiple tyrosine kinase receptors involved in tumor cell proliferation, survival, and angiogenesis. KN046 is designed to simultaneously block PD-L1 and CTLA-4 pathways, reducing tumor-induced immune suppression and enhancing anti-tumor immune responses. The combination aims to provide synergistic anti-tumor effects, particularly for advanced hepatocellular carcinoma (HCC) and late-stage gastrointestinal tumors, by combining direct anti-proliferative action with potent immune modulation. Clinical development is ongoing, with phase I/II studies evaluating safety and efficacy in advanced gastrointestinal tumors and advanced/metastatic hepatocellular carcinoma[1][2][4].

Other names
donafenib tosylate + KN046Zelgen-Donafenib + Alphamab-KN046
02

Targets

VEGFR2 (Vascular endothelial growth factor receptor 2)RAF1 (c-Raf-1 (Y340D/Y341D))CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)KIT (c-KIT proto-oncogene receptor tyrosine kinase)CD274 (Programmed cell death protein 1 ligand 1)PDGFRB (Platelet-derived growth factor receptor beta)BRAF (B-Raf proto-oncogene, serine/threonine kinase)FLT3 (Fms related receptor tyrosine kinase 3)

Beyond the preview

Go deeper on donafenib + KN046.

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 donafenib + KN046.

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