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pp-078

Injection

Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
Japan
Comments
Indication: Vocal cord scarring (vocal fold fibrosis) causing impaired phonation and reduced vocal function. Clinical stage: Phase I/II open-label dose-escalation investigator-initiated trial completed; Phase III multicenter, randomized, placebo-controlled, double-blind comparative trial ongoing. Mechanism / Target: the c-MET receptor activation to promote antifibrotic activity, tissue repair, and regeneration within the vocal fold lamina propria, aiming to restore pliability and vocal fold vibration. Route / form: Local intracordal injection into the vocal fold, as used in clinical studies. Differentiation: First-in-class regenerative biologic directly targeting fibrosis and restoring vocal function; demonstrated safety and biological activity in early trials and is advancing through pivotal evaluation.
Manufacturer #38606

A clinical-stage biopharmaceutical firm pioneering regenerative medicines based on a human growth factor protein. It develops therapies for intractable and rare diseases — including spinal-cord injury, organ damage, and tissue scarring — with global development and commercialization ambitions.

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