pp-044 Solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
Comments
Indication: Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), especially HPV-negative disease, typically in combination with cetuximab.
Clinical stage: Phase 3 global development.
Modality: Biologic (humanized IgG1 monoclonal antibody).
Mechanism / Target: Anti-HGF / c-MET monoclonal antibody blocking the hepatocyte-growth-factor pathway involved in tumor growth, invasion, and resistance to EGFR inhibitors.
Route / form: Intravenous infusion.
Differentiation: Targets HGF-mediated resistance pathways and has shown enhanced activity in combination with cetuximab. Oncology is a wholly owned subsidiary and does not make independent partnering decisions.
Manufacturer #16907
This South Korea–based life-sciences organization develops a portfolio of small-molecule and biologic therapeutics, with a strategic focus on oncology, immunology, and metabolic diseases. Its pharmaceutical R&D is supported by global clinical programs and collaborations aimed at advancing first-in-class and best-in-class candidates. The group also maintains established therapeutic franchises and leverages international partnerships to expand its presence in the global healthcare market.
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