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tregzi

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

tregzi

Proper name

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

Licence type

351(a)

BLA number

125868

Applicant

Orca Biosystems Inc.

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
>=1.0 10^6HSPC CELLS,0.9-3.510^6 TREG CELLS,0.9-6.910^6 TCON CELLS /PATIENT KG	Solution	Intravenous	Bag	Rx	June 30, 2026

Purple Book	FDA	Licence type, presentations, reference product, exclusivity