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Sintilimab - Eli Lilly and Company/Innovent Biologics

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Drug Profile

Sintilimab - Eli Lilly and Company/Innovent Biologics

Alternative Names: Anti-PD-1 antibody - Eli Lilly and Company/Innovent Biologics; IBI 308; LY-3342901; Sintilimab injection; Sintilimab injection - Eli Lilly and Company/Innovent Biologics; Tyvyt; Xindili Dankang

Latest Information Update: 12 Jun 2025

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At a glance

  • Originator Adimab; Innovent Biologics
  • Developer Chinese Academy of Medical Sciences; Eli Lilly and Company; Fujian Cancer Hospital; HUTCHMED; Innovent Biologics; Jiangsu Hengrui Medicine Co.; Jiangsu Provincial Peoples Hospital; Laekna Therapeutics; Peking University; Shanghai Jiaotong University School of Medicine; Sun Yat-Sen 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Gastric cancer; Hodgkin's disease; Liver cancer; Non-small cell lung cancer; Oesophageal cancer
  • Registered Endometrial cancer
  • Preregistration Renal cell carcinoma
  • Phase III Acral lentiginous melanoma; Colorectal cancer; Nasopharyngeal cancer
  • Phase II Cervical cancer; Extranodal NK-T-cell lymphoma; Neuroendocrine tumours; Small cell lung cancer
  • Phase I/II Solid tumours
  • Phase I Cancer; Lung cancer; Lymphoma

Most Recent Events

  • 04 Jun 2025 Preregistration for Renal cell carcinoma (Late-stage disease, Combination therapy, Metastatic disease, Second-line therapy or greater) in China (IV)
  • 04 Jun 2025 NMPA accepts NDA for Sintilimab for Renal cell carcinoma for review
  • 02 Apr 2025 9438205 - Updated KDM, no significant sci data mentioned

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