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Ipilimumab biosimilar - Henlix Biotech

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Drug Profile

Ipilimumab biosimilar - Henlix Biotech

Alternative Names: HLX-13

Latest Information Update: 23 Dec 2025

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At a glance

  • Originator Henlix Biotech
  • Developer Shanghai Henlius Biotech
  • Class Antineoplastics; Antiretrovirals; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 inhibitors; 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 No

Highest Development Phases

  • Phase I Colorectal cancer; Endometrial cancer; Liver cancer; Malignant melanoma; Malignant-mesothelioma; Non-small cell lung cancer; Renal cell carcinoma

Most Recent Events

  • 25 Nov 2025 Phase-I clinical trials in Liver cancer (First-line therapy, Inoperable/Unresectable, Metastatic disease, Late-stage disease) in China (Parenteral) (NCT07176650)
  • 23 Sep 2025 Shanghai Henlius Biotech plans a phase I trial for Liver-cancer (First-line therapy, Unresectable diseases, Metastatic disease, Late-stage disease) (Parenteral) in October 2025 (NCT07176650)
  • 16 May 2025 Phase-I/III clinical trials in Liver cancer (Late-stage disease, Metastatic disease, First-line therapy, Inoperable/Unresectable, In combination therapy) in China (IV) (NCT06841185)

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