Drug intelligence / Profile preview

BD111

Development stage
Phase 1
Lead developer
Shanghai BDgene Therapeutics
Modality
CRISPR-Cas9 → CRISPR Systems → Programmable Nucleases → Gene Editing → Gene Therapies, mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Lentiviral Vectors → Retroviral Vectors → Viral Vectors → Gene Addition/Replacement → Gene Therapies
Administration
Ophthalmic
01

Overview

BD111 is an investigational gene therapy developed by Shanghai BDgene Technology for the treatment of herpes simplex virus type 1 (HSV-1) stromal keratitis. It utilizes a lentivirus-like particle (VLP) delivery system to administer CRISPR/Cas9 gene editing components—specifically SpCas9 mRNA and guide RNA cassettes—directly into the corneal stroma. The mechanism of action involves targeted cleavage and degradation of the HSV-1 viral genome within infected cells, aiming to eliminate both active and latent viral reservoirs in ocular tissues such as the cornea and trigeminal ganglion. Unlike conventional antiviral drugs that only inhibit viral replication, BD111 seeks to eradicate HSV-1 DNA from host tissues, potentially offering a one-time curative approach for recurrent or chronic herpetic stromal keratitis. The product has received FDA orphan drug designation and is currently in Phase 1/2 clinical trials in China[1][2][3][4][5][7].

Other names
HSK-BD111HSK-BD-111HSK-BD 111BD-111BD111BD 111
02

Targets

HSV-1 (Herpes simplex virus type 1)

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