Description
Pirtobrutinib Tablets Product Specifications
| Attribute | Details |
|---|---|
| Product Name | Pirtobrutinib Tablets (Jaypirca) |
| Formulation | Film-coated tablet, 100mg |
| 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
FDA (Jan 2023): Accelerated approval for R/R MCL after ?2 prior treatments fr.wikipedia.org+8fda.gov+8onclive.com+8.
EU (Nov 2023): EMA authorized Jaypirca for R/R MCL; CHMP recommended for R/R CLL
China (Oct 2024): NMPA approval as Jaypirca 50?mg/100?mg tablets under HJ20240116
Research Applications
Suitable for preclinical and translational oncology research, including:
BTK pathway and resistance studies
In vitro cytotoxicity assays and animal models
Combinatorial investigations with immunotherapies or targeted agents
Handling & Storage
Storage: Room temperature 20–25°C (per USP), excursions 15–30°C
Handling: Standard lab PPE required; avoid ingestion, inhalation, skin/eye contact. Use biosafety protocol.
References
China NMPA approval under HJ20240116
FDA accelerated approval Jan 2023 (MCL)
EMA authorization & CHMP opinion
Clinical and prescribing info: dosage, interactions, warnings


manuelarana –
I’ve been looking for it for a long time, thank you