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pp-059

Solution for infusion

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, EU GMP
Comments
Indication: Relapsed or refractory Claudin 18.2–positive solid tumors, including gastric and gastroesophageal junction cancers, with cohorts structured by moderate-to-high, low, and ultra-low antigen expression. Clinical stage: Phase 1/2 clinical development. Modality: Antibody–drug conjugate (ADC) Mechanism / Target: High-affinity antibody targeting Claudin 18.2 linked to a cytotoxic payload, enabling selective internalization and tumor cell killing even in low-antigen-density tumors. Route / form: Intravenous infusion Differentiation: Designed to treat a broad range of Claudin 18.2 expression levels, potentially expanding therapeutic reach beyond earlier Claudin 18.2 therapies that require high antigen expression.
Manufacturer #38613

A clinical-stage biopharmaceutical company advancing innovative cancer medicines from early discovery through commercialization. It focuses on targeted oncology and immuno-oncology therapeutics to address unmet needs through global development and strategic partnerships. The organization integrates R&D, manufacturing, and commercialization efforts (US, CN)

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