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Ipilimumab biosimilar - Innovent Biologics

Drug Profile

Ipilimumab biosimilar - Innovent Biologics

Alternative Names: Anti-CTLA-4 antibody - Innovent Biologics; IBI-310; Ipilimumab N01

Latest Information Update: 06 Apr 2026

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At a glance

  • Originator Innovent Biologics
  • Developer Innovent Biologics; Peking University
  • Class Antineoplastics; Antiretrovirals; Immunotherapies; Monoclonal antibodies; Recombinant fusion proteins
  • 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

  • Registered Colorectal cancer
  • Phase III Acral lentiginous melanoma; Liver cancer
  • Phase II Cervical cancer; Gastric cancer; Neuroendocrine tumours
  • Phase I/II Biliary cancer; Nasopharyngeal cancer
  • No development reported Non-small cell lung cancer; Renal cell carcinoma; Solid tumours

Most Recent Events

  • 01 Apr 2026 Tianjin Medical University Cancer Institute and Hospital plans a phase II trial for Colorectal cancer (Combination therapy, Metastatic, Late-stage disease, Inoperable/Unresectable) (IV) in March 2026 (NCT07506109)
  • 24 Mar 2026 Innovent Biologics plans a phase II/III for Liver cancer (first-line therapy, Late-stage diseases, Combination therapy, In operable/Unresectable) in China (IV), in March 2026 (NCT07490262)
  • 18 Mar 2026 Sun Yat-sen University in collaboration with Innovent Biologics plans the phase II ACTION-001 trial for Liver cancer (Combination therapy, Neoadjuvant therapy, First-line therapy) (IV) (NCT07487662)

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