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Trastuzumab botidotin - Klus Pharma

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Drug Profile

Trastuzumab botidotin - Klus Pharma

Alternative Names: A-166

Latest Information Update: 16 Apr 2025

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At a glance

  • Originator Klus Pharma
  • Developer Klus Pharma; Sichuan Kelun-Biotech Biopharmaceutical
  • Class Antineoplastics; Auristatins; Drug conjugates; Immunoconjugates; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action Tubulin inhibitors
  • 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

  • Preregistration HER2 positive breast cancer
  • Phase II Breast cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 07 Jan 2025 Preregistration for HER2-positive-breast-cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Monotherapy, Second-line therapy or greater) in China (IV) prior to January 2025
  • 07 Jan 2025 NMPA accepts NDA for Trastuzumab botidotin for HER2-positive breast cancer for review
  • 11 Jul 2022 Phase-II clinical trials in Breast cancer (Late-stage disease, Second-line therapy or greater) in China (IV) (KLUS Pharma pipeline, July 2022)

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