pp-143 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
Hong Kong
GMP approvals
China
Comments
Indication: Primary immune thrombocytopenia (ITP); warm autoimmune haemolytic anaemia (wAIHA)
Clinical stage: Phase 3 completed (ITP, China — NDA filed); Phase 2 ongoing (wAIHA)
Modality: Small molecule
Mechanism / Target: Syk (spleen tyrosine kinase) inhibitor — blocks B-cell receptor and Fcγ receptor signalling; reduces autoantibody production and platelet/RBC destruction
Route / form: Oral tablet (once daily)
Differentiation: Oral Syk inhibitor in ITP; differentiated target from TPO-RA class (romiplostim, eltrombopag); also applicable to B-cell-driven haemolytic anaemia
Manufacturer #39174
Commercial-stage oncology and immunology company with focus on China and global expansion. Develops and commercialises targeted therapies for cancers and autoimmune diseases. Wholly owned late-stage assets with NDA filings and approved products in China.
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