Drug Profile

Dalnacogene ponparvovec - Belief Biomed

Alternative Names: BBM-H901

Latest Information Update: 16 Apr 2025

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At a glance

Originator Belief Biomed
Class Antihaemorrhagics; Gene therapies
Mechanism of Action Factor IX replacements; Gene transference

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Haemophilia B
New Molecular Entity No

Highest Development Phases

Registered Haemophilia B

Most Recent Events

10 Apr 2025 Registered for Haemophilia B in China (IV) - First global approval
07 Dec 2024 Efficacy and adverse event data from a phase III trial in Haemophilia B presented at the 66^th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
06 Nov 2024 US FDA grants Rare Pediatric Disease Designation (RPDD) to dalnacogene ponparvovec for Haemophilia B prior to November 2024

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