GC Biopharma secures Hunterraze approvals in India and Taiwan

GC Biopharma has received marketing authorization for its Hunter syndrome treatment, Hunterraze, in India and Taiwan. The intravenous formulation, Hunterraze IV, was approved by India’s Central Drugs Standard Control Organization (CDSCO) and Taiwan’s Food and Drug Administration (TFDA).

Additionally, the Taiwan TFDA approved the Hunterraze ICV formulation, which is administered directly into the cerebral ventricles to target central nervous system symptoms. With these approvals, Hunterraze IV is now authorized in 14 countries, while the ICV formulation is available in four.

The company aims to expand its presence in the Asian rare disease market, following previous approvals in Japan, China, and Malaysia. India is noted for its high unmet medical needs due to low existing treatment rates, while Taiwan offers strong market accessibility through established patient screening and support systems.