HENLIUS Secures Regulatory Approval for Phase 1 Trial of Self-Developed HLXTEHAase02

Stock News03-31

HENLIUS (02696) announced that the Investigational New Drug (IND) application for the Phase 1 clinical trial of its self-developed HLXTEHAase02 (recombinant human hyaluronidase injection) has been approved by the National Medical Products Administration (NMPA). The company plans to initiate the related clinical trial in mainland China once the necessary conditions are met. HLXTE-HAase02 is a novel recombinant human hyaluronidase (rHuPH20) developed by HENLIUS, intended to enhance the diffusion and absorption of subcutaneously injected or infused drugs. Under physiological conditions, HLXTE-HAase02 specifically and reversibly degrades hyaluronic acid in the subcutaneous tissue locally, increasing the volume for subcutaneous administration and improving the dispersion and permeability of drugs within the tissue. This leads to enhanced drug bioavailability and better patient compliance with subcutaneous dosing. The product is designed for use in the development of subcutaneous drug delivery systems, facilitating more effective subcutaneous administration of therapeutics. Non-clinical studies have demonstrated that HLXTE-HAase02 exhibits enzyme activity comparable to that of marketed recombinant human hyaluronidase products.

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