Drug Profile

Dalcinonacog alfa - GC biopharma

Alternative Names: CB-2679d; CB-FIX; DalcA; Dalcinonacog alfa - Gyre Therapeutics/ISU Abxis; Factor IX - Gyre Therapeutics ; FIX-NG; ISU-304

Latest Information Update: 01 Nov 2023

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At a glance

Originator Catalyst Biosciences
Developer Gyre Therapeutics; ISU Abxis
Class Antihaemorrhagics; Blood coagulation factors; Peptide hydrolases; Recombinant proteins
Mechanism of Action Factor IX replacements

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 Yes
Available For Licensing Yes - Haemophilia

30 Oct 2023 GNI has merged with Catalyst Biosciences to form Gyre Therapeutics
27 Feb 2023 GC Biopharma acquires Dalcinonacog alfa from Catalyst Bioscience
14 Nov 2022 Phase-II development for Haemophilia B (In adolescents, In children, Treatment-experienced, In adults) is still ongoing in South Africa (IV)

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