Hainan Haiyao Subsidiary Receives Drug Registration Certificate for Isavuconazonium Sulfate for Injection

SHENZHEN, China — Hainan Haiyao Co., Ltd (000566.SZ) announced Thursday that its wholly owned subsidiary, Haikou Pharmaceutical Factory Co., Ltd, has received a Drug Registration Certificate from China's National Medical Products Administration for isavuconazonium sulfate for injection.

The approval marks a significant milestone for the pharmaceutical company, which specializes in antifungal therapies. Isavuconazonium sulfate is a next-generation broad-spectrum triazole antifungal agent indicated for the treatment of invasive aspergillosis and invasive mucormycosis—two serious and potentially life-threatening fungal infections.

According to the company, the drug demonstrates several clinical advantages over existing antifungal treatments. These include favorable prodrug water solubility, high bioavailability, and predictable linear pharmacokinetic properties. The injectable formulation is free of cyclodextrin and other nephrotoxic excipients commonly found in other antifungal medications, reducing potential kidney-related risks.

Once administered, the drug is rapidly converted to its active metabolite by plasma esterases. Its molecular structure features side chains with high affinity for the fungal CYP51 protein, enabling a broad antifungal spectrum that includes fungi resistant to other azole-class antifungal drugs.

The Shenzhen-listed company did not disclose financial details related to the approval or provide commercialization timelines.

Source: Gelonghui, company announcement