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Rulonilimab - Shandong New age Pharmaceutical

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Drug Profile

Rulonilimab - Shandong New age Pharmaceutical

Alternative Names: Anti PD-1 monoclonal antibody - Shandong New Age Pharmaceutical; Anti-programmed cell death-1 monoclonal antibody - Shandong New Age Pharmaceutical; F-520; Recombinant humanized anti-PD-1 monoclonal antibody

Latest Information Update: 20 Aug 2026

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At a glance

  • Originator Shandong New age Pharmaceutical
  • 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

  • Phase II/III Cervical cancer; Liver cancer; Unknown primary neoplasms
  • Phase II Solid tumours
  • No development reported Lymphoma

Most Recent Events

  • 08 Jul 2026 Phase-II/III clinical trials in Unknown primary neoplasms (First-line therapy, Combination therapy, Metastatic disease) in China (IV) (NCT07761429)
  • 26 Sep 2024 Phase-II/III clinical trials in Cervical cancer (Combination therapy, Recurrent, Metastatic disease, First-line therapy, Inoperable/Unresectable, Late-stage disease) in China (IV) (NCT06755515)
  • 03 Jan 2024 Shandong New Time Pharmaceutical completes a phase II trial in Cervical cancer (Late-stage disease, Recurrent, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater) in China (IV) (NCT06226350)

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