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Ipilimumab biosimilar - Innovent Biologics

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Drug Profile

Ipilimumab biosimilar - Innovent Biologics

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

Latest Information Update: 28 Apr 2025

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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

  • Preregistration 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

  • 28 Apr 2025 No recent reports of development identified for clinical-Phase-Unknown development in Renal-cell-carcinoma in Unknown (IV)
  • 24 Feb 2025 Preregistration for Colorectal cancer (Combination therapy, Neoadjuvant therapy) in China (IV)
  • 24 Feb 2025 CDE of China's NMPA accepts NDA for ipilimumab biosimilar for Colorectal cancer (Combination therapy, Neoadjuvant therapy) in China (IV)

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