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
, 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)