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Disitamab vedotin - Yantai Rongchang Pharmaceutical

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Drug Profile

Disitamab vedotin - Yantai Rongchang Pharmaceutical

Alternative Names: Aidixi; PF-08046051; RC 48; RC 48-ADC; Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate - Yantai Rongchang Pharmaceutical

Latest Information Update: 28 Nov 2025

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At a glance

  • Originator Yantai Rongchang Biological Engineering
  • Developer Pfizer; RemeGen; Seagen
  • Class Antineoplastics; Auristatins; Drug conjugates; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; Mitosis inhibitors; Tubulin inhibitors; Tubulin polymerisation inhibitors
  • Orphan Drug Status

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

    Yes - Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Gastric cancer
  • Registered Urogenital cancer
  • Preregistration HER2 positive breast cancer
  • Phase II Biliary cancer; Bladder cancer; Breast cancer; Cervical cancer; Gynaecological cancer; Malignant melanoma; Solid tumours
  • Phase I/II Non-small cell lung cancer
  • Phase I Prostate cancer

Most Recent Events

  • 28 Nov 2025 No recent reports of development identified for phase-I development in Gastric-cancer(Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (Parenteral, Injection)
  • 20 Oct 2025 Updated efficacy data from the phase III RC48-C016 trial in Urogenital cancer released by RemeGen
  • 30 Jun 2025 Phase-I/II clinical trials in Breast cancer (Inoperable/Unresectable, Metastatic disease, Late-stage disease, Second-line therapy or greater) in Puerto Rico, USA (IV) (NCT06966453)

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