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HX 009

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Drug Profile

HX 009

Alternative Names: anti-PD-1/CD47 infusion protein; HX-009; Recombinant humanised anti-CD47/PD-1 bifunctional antibody HX009 injection

Latest Information Update: 08 Mar 2025

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At a glance

  • Originator Waterstone Hanxbio
  • Developer HanX Biopharmaceuticals; Waterstone Hanxbio
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD47 antigen inhibitors; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Solid tumours
  • Phase I/II Lymphoma; Malignant melanoma

Most Recent Events

  • 08 Mar 2025 Phase-I/II clinical trials in Solid tumours (Late-stage disease, Combination therapy, Metastatic disease, Inoperable/Unresectable) in China (IV) (NCT06708663)
  • 17 Jan 2025 Phase-I/II clinical trials in Malignant melanoma (Metastatic disease, Inoperable/Unresectable, Combination therapy, Late-stage disease) in China (IV) (NCT06708663)
  • 07 Dec 2024 Efficacy and adverse events data from a Phase-I/II clinical trials in Lymphoma presented at the 66th American Society of Hematology Annual Meeting and Exposition(ASH-Hem-2024)

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