Ipilimumab biosimilar - Henlix Biotech
Alternative Names: HLX-13Latest Information Update: 29 May 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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
- 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)
- 29 Apr 2025 Sandoz in-licenses ipilimumab biosimilar from Shanghai Henlius Biotech for commercialization in USA, Japan, Australia, Europe and USA
- 24 Feb 2025 Shanghai Henlius Biotech plans to initiate a phase III trial for Hepatocellular Carcinoma (First-line therapy, Unresectable diseases, Metastatic disease, In combination therapy, Late-stage disease) (Parenteral) (NCT06841185)