描述
Pirtobrutinib Tablets Product Specifications
Attribute | Details |
---|---|
Product Name | Pirtobrutinib Tablets (Jaypirca) |
Formulation | Film-coated tablet, 100?mg |
Pack Size | 14 tablets × 4 blisters = 56 tablets per box |
Approval No. | China NMPA HJ20240116 |
Product Code | 86978403001613 |
Manufacturer | Lilly del Caribe, Inc. |
Intended Use | Research/Investigational use only; not for human use |
Pirtobrutinib Tablets Overview & Mechanism
Pirtobrutinib is a highly selective, non-covalent Bruton’s Tyrosine Kinase (BTK) inhibitor. It is effective against BTK-resistant mutations and approved for relapsed/refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in the US, EU, and China medlineplus.gov+15biopharmaboardroom.com+15trial.medpath.com+15
Pirtobrutinib Tablets Key Clinical Notes
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FDA (Jan 2023): Accelerated approval for R/R MCL after ?2 prior treatments fr.wikipedia.org+8fda.gov+8onclive.com+8.
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EU (Nov 2023): EMA authorized Jaypirca for R/R MCL; CHMP recommended for R/R CLL
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China (Oct 2024): NMPA approval as Jaypirca 50?mg/100?mg tablets under HJ20240116
Research Applications
Suitable for preclinical and translational oncology research, including:
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BTK pathway and resistance studies
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In vitro cytotoxicity assays and animal models
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Combinatorial investigations with immunotherapies or targeted agents
Handling & Storage
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Storage: Room temperature 20–25?°C (per USP), excursions 15–30?°C
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Handling: Standard lab PPE required; avoid ingestion, inhalation, skin/eye contact. Use biosafety protocol.
? References
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China NMPA approval under HJ20240116 pi.lilly.com+3trial.medpath.com+3biospectrumasia.com+3
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FDA accelerated approval Jan 2023 (MCL) en.wikipedia.org+6jhoponline.com+6biopharmaboardroom.com+6
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EMA authorization & CHMP opinion ema.europa.eu+1onclive.com+1
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Clinical and prescribing info: dosage, interactions, warnings fr.wikipedia.org
manuelarana –
I’ve been looking for it for a long time, thank you