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1 products found

pp-058

Tablets

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
United States
GMP approvals
FDA, EU GMP
Registered in
Australia , Austria , Bulgaria , China , Czech Republic , Denmark , Finland , France , Germany , Hong Kong , Italy , Malta , Netherlands , New Zealand , Norway , Poland , Romania , Spain , Sweden , Taiwan , United Kingdom , United States
Comments
Indication: Relapsed or refractory diffuse large B-cell lymphoma in patients who have progressed after multiple prior systemic therapies. Clinical stage: Commercialized in several regions with ongoing clinical development in additional hematologic malignancy settings. Modality: Small molecule Mechanism / Target: Selective inhibitor of nuclear export acting on XPO1 to block nuclear export of tumor suppressor proteins and disrupt oncogenic signaling. Route / form: Oral tablets Differentiation: First-in-class selective nuclear export inhibitor with demonstrated activity in heavily pretreated lymphoma populations and a distinct mechanism from existing cytotoxic or targeted agents.
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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