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SHR 8068

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Drug Profile

SHR 8068

Alternative Names: SHR-8068

Latest Information Update: 09 Dec 2025

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At a glance

  • Originator Suzhou Suncadia Biopharmaceuticals
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T-lymphocyte antigen 4 modulators; 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 Yes

Highest Development Phases

  • Phase III Liver cancer; Non-small cell lung cancer
  • Phase II Biliary cancer; Colorectal cancer; Gastric cancer; Oesophageal cancer; Solid tumours
  • Phase I/II Urogenital cancer

Most Recent Events

  • 05 Dec 2025 Shanghai Zhongshan Hospital plans a phase II CATALIS trial for Adenocarcinoma (Neoadjuvant therapy, Late-stage disease, Combination therapy) (IV) in January 2026 (NCT07266025)
  • 20 Nov 2025 Suzhou Suncadia Biopharmaceuticals plans a phase I/II trial for Renal cell carcinoma (Late-stage disease, Metastatic disease, Combination therapy) in China, in December 2025 (NCT07239596)
  • 17 Nov 2025 Suzhou Suncadia Biopharmaceuticals plans a phase-III trial for Biliary cancer (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in China (Parenteral), (NCT07229625)

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