HENLIUS's self-developed HLXTEHAase02 has been approved for phase I clinical trial application.

HENLIUS (02696) announced that the company's self-developed Phase 1 clinical trial application for HLXTE-HAase02 (recombinant human hyaluronidase injection) has been approved by the National Medical Products Administration (NMPA). The company plans to conduct relevant clinical trials in mainland China (excluding Hong Kong, Macau, and Taiwan) once conditions are met. HLXTE-HAase02 is a new recombinant human hyaluronidase (rHuPH20) developed by the company, intended to promote the diffusion and absorption of subcutaneous injections or infusions. Under physiological conditions, HLXTE-HAase02 can locally and reversibly specifically depolymerize subcutaneous tissue hyaluronic acid, increasing the volume of subcutaneous drug administration, enhancing drug dispersion and permeability in subcutaneous tissue, thereby increasing drug bioavailability and improving patient compliance with subcutaneous administration. HLXTE-HAase02 is intended for the development of subcutaneous drug delivery products, assisting these drugs in achieving more effective subcutaneous delivery. Non-clinical studies have shown that HLXTE-HAase02 exhibits enzyme activity comparable to currently marketed recombinant human hyaluronic acid products.