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Sonesitatug Vedotin - Lepu Biopharma

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Drug Profile

Sonesitatug Vedotin - Lepu Biopharma

Alternative Names: AZD-0901; CMG 901

Latest Information Update: 08 Sep 2025

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At a glance

  • Originator KeyMed Biosciences; Miracogen
  • Developer AstraZeneca; KeyMed Biosciences
  • Class Antineoplastics; Auristatins; Drug conjugates; Immunoconjugates; Immunotherapies; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; Mitosis 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 - Oesophageal cancer; Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Adenocarcinoma
  • Phase II Solid tumours

Most Recent Events

  • 25 Aug 2025 AstraZeneca plans a phase II GAMBIT trial for Adenocarcinoma (Second-line therapy or greater, Metastatic disease, Late-stage disease, Inoperable/unresectable) in Russia(IV) in August 2025 (NCT07143604)
  • 14 Jul 2025 AstraZeneca plans the phase II GEMINI-PeriOp GC trial for Adenocarcinoma (Combination therapy, Late-stage disease, First-line therapy) in USA, Canada, China, Georgia, Italy, Japan, Poland, Spain, Taiwan, Turkey, United Kingdom (IV, Infusion), in July 2025 (NCT07069712) (EUCT2024-516909-23-00)
  • 28 Apr 2024 No recent reports of development identified for phase-I development in Solid-tumours(Inoperable/Unresectable, Late-stage disease, Monotherapy, Refractory metastatic disease, Second-line therapy or greater) in China (IV)

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