pp-087 Tablets
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, China
Unavailable markets
China
Registered in
China
Comments
Indication: Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) requiring systemic treatment after prior therapy including BTK inhibitors; additional development ongoing in multiple hematologic malignancies and select solid tumors.
Clinical stage: China conditional approval (2025) for treated CLL/SLL; global Phase Ib/II and four Phase III trials in CLL/SLL, AML, MDS.
Modality: Small-molecule.
Mechanism: Highly selective inhibitor of BCL-2 that restores apoptotic signaling in malignant cells; designed with a short elimination half-life and high Cmax to achieve potent “hit-and-run” target engagement while potentially reducing systemic toxicities.
Route: Oral.
Differentiation: First China-approved BCL-2 inhibitor; rapid 1-week ramp-up with lower toxicity potential.
Manufacturer #38620
A global, clinical-stage biopharmaceutical company discovering, developing and commercializing small-molecule therapies addressing unmet needs in hematological cancers and other serious diseases. It advances programs through international registrational trials with strategic development and partnership goals. The organization integrates R&D and global expansion efforts.