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Trastuzumab biosimilar - Alteogen/Cristalia/Qilu Pharmaceutical

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Drug Profile

Trastuzumab biosimilar - Alteogen/Cristalia/Qilu Pharmaceutical

Alternative Names: ALT 02; ALT L2; ALT LS2; Herceptin biosimilar; QL-1701

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Alteogen
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; ERBB 2 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III HER2 positive breast cancer
  • Preclinical Gastric cancer

Most Recent Events

  • 13 Apr 2023 Qilu Pharmaceutical completes a phase III trial in HER-positive breast cancer (First-line therapy, Metastatic disease, Recurrent, Combination therapy) in China (IV) (NCT05629949)
  • 13 Oct 2021 Phase-II clinical trials in HER-positive breast cancer (In volunteers) in Canada (IV) (Alteogen pipeline, October 2021)
  • 13 Oct 2021 Preclinical development is still ongoing for Breast cancer and Gastric cancer in South Korea (SC) (Alteogen pipeline, October 2021)

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