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Toripalimab - Shanghai Junshi Biosciences

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Drug Profile

Toripalimab - Shanghai Junshi Biosciences

Alternative Names: Anti-PD1 monoclonal antibody - Shanghai Junshi Biosciences; CHS-007; JS 001; JS-001sc; LOQTORZI; SO-001; TAB-001; Terepril monoclonal antibody; toripalimab-tpzi; Treipril monoclonal antibody; Treprizumab; Treprizumab - Shanghai Junshi Biosciences; Tripleitriumab; Triprizumab; TUOYI; Tuoyi

Latest Information Update: 25 Jul 2024

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At a glance

  • Originator Elpiscience Biopharmaceuticals; Shanghai Junshi Biosciences
  • Developer Ascentage Pharma; Coherus BioSciences; Fudan University; GenFleet Therapeutics; HUTCHMED; I-MAB Biopharma; Peking Union Medical College Hospital; Peking University; RemeGen; Shanghai Junshi Biosciences; Sun Yat-Sen University; Suzhou Yasheng Pharmaceutical; Xiangya Hospital of Central South 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 - Nasopharyngeal cancer; Malignant melanoma; Oesophageal cancer; Small cell lung cancer; Soft tissue sarcoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Malignant melanoma; Nasopharyngeal cancer; Non-small cell lung cancer; Squamous cell cancer; Urogenital cancer
  • Registered Renal cancer; Small cell lung cancer; Triple negative breast cancer
  • Preregistration Liver cancer
  • Phase III Gastric cancer; Hodgkin's disease; Neuroendocrine tumours
  • Phase II Biliary cancer; Bladder cancer; Breast cancer; Cancer; Colorectal cancer; Solid tumours; Thyroid cancer
  • Phase I/II Head and neck cancer; Liposarcoma; Lung cancer
  • No development reported Alveolar soft part sarcoma; Lymphoma

Most Recent Events

  • 18 Jul 2024 Preregistration for Liver cancer (Combination therapy, Inoperable/Unresectable, First-line therapy, Late-stage disease, Metastatic disease) in China (IV) before July 2024
  • 18 Jul 2024 National Medical Products Administration (NMPA), China accepts sBLA for Toripalimab for Liver cancer (Combination therapy, First-line therapy) in China (IV) for review
  • 11 Jul 2024 Phase-III clinical trials in Non-small cell lung cancer (Combination therapy, First-line therapy, Recurrent, Metastatic disease) in China (SC) (NCT06505837)
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