Drug Profile

Tislelizumab - BeOne Medicines

Alternative Names: BGB-A317; TEVIMBRA; Tilelizumab; Tirelizumab - BeiGene; Tislelizumab-jsgr; Tizveni; VDT-482

Latest Information Update: 14 Jun 2025

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At a glance

Originator BeiGene
Developer Asieris Pharmaceuticals; BeiGene; BeOne Medicines; Celgene Corporation; HUTCHMED; Leap Therapeutics; Novartis; Tianjin Medical University
Class Antineoplastics; Immunotherapies; Monoclonal antibodies
Mechanism of Action Antibody-dependent cell cytotoxicity; 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.

Yes - Squamous cell cancer; Nasopharyngeal cancer; Liver cancer
New Molecular Entity Yes

Marketed Hodgkin's disease; Liver cancer; Non-small cell lung cancer; Oesophageal cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
Registered Adenocarcinoma; Nasopharyngeal cancer
Preregistration Small cell lung cancer
Phase III Cancer
Phase II Bladder cancer; Cervical cancer; Colorectal cancer; Lung cancer; Lymphoma; Rectal cancer
Phase I/II Endometrial cancer; Haematological malignancies; Triple negative breast cancer
No development reported Ovarian cancer; Renal cancer

27 May 2025 Preregistration for Nasopharyngeal cancer (Combination therapy, First-line therapy, Metastatic disease, Recurrent) in European Union (IV), prior to Mya 2025
27 May 2025 Committee for Medicinal Products for Human Use (CHMP) of EMA adopts a positive opinion for Tislelizumab for Nasopharyngeal cancer (Combination therapy, First-line therapy, Metastatic disease, Recurrent)
07 May 2025 RemeGen Co plans a phase III trial for Adenocarcinoma (Late stage disease, Metastatic disease, First line therapy, Combination therapy) in China (IV) in May 2025 (NCT06944496)

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