UNI-BIO GROUP: The listing application for Isavuconazole capsules has been officially accepted by the National Medical Products Administration of China

According to the Zhitong Finance APP, UNI-BIO GROUP (00690) announced that the listing application for Isavuconazole sulfate capsules submitted by the group has been officially accepted by the National Medical Products Administration (NMPA) of China, with acceptance number "CYHS2502599". This marks an important milestone for the group in the field of antifungal treatment, with Isavuconazole sulfate capsules expected to be approved for market launch in the second half of 2026. It will provide more effective and safer high-quality treatment options for patients with invasive fungal infections (such as invasive aspergillosis and invasive mucormycosis).

Isavuconazole sulfate is a new triazole antifungal drug with broad-spectrum antibacterial activity. Its mechanism of action involves inhibiting cytochrome P 450 to block the synthesis of ergosterol in the fungal cell membrane, thereby weakening the structure and function of the fungal cell membrane. Clinical studies have shown that Isavuconazole sulfate is effective and has good safety, providing a reliable treatment option for patients with life-threatening fungal infections.

The launch of Isavuconazole sulfate capsules will create a synergistic effect with the existing product, Pinafu® (Voriconazole tablets), further consolidating the group's leading position in the antifungal market. Pinafu® has already achieved sales coverage in public hospitals nationwide, and to enhance product accessibility and profitability, the group is actively expanding its influence in the pharmacy network. Leveraging the established sales network and a professional sales team for antifungal drugs, Isavuconazole sulfate capsules will achieve efficient commercial operation and maximize market penetration.

To ensure the high-quality production and stable supply of Isavuconazole sulfate, the group has specifically renovated a customized dedicated production line. This production line is equipped with advanced capsule filling and aluminum-plastic packaging equipment, meeting strict industry standards to ensure the accuracy and consistency of each batch of products. The cutting-edge technology required for the production of Isavuconazole sulfate capsules, which differs from other manufacturers, creates a competitive advantage for the group. In addition, the group has established strategic partnerships with high-quality raw material suppliers to ensure a stable supply of high-quality raw materials and cost advantages, further consolidating its dual leading position in cost-effectiveness and product quality.

The global antifungal drug market is expected to grow significantly, with the Chinese market projected to reach approximately RMB 30 billion by 2030, with a compound annual growth rate of over 10%. As a new generation of treatment options, the group is fully prepared to capture a considerable share in this rapidly expanding market.

Looking ahead, the launch of Isavuconazole sulfate capsules will further enrich the group's product pipeline, strengthen its leadership position in the antifungal field, and contribute new momentum to sales growth. By responding to the growing market demand for innovative and effective therapies, the group will continue to promote its firm commitment to biopharmaceutical innovation, providing value to patients, and achieving sustainable growth for shareholders