March 31, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the investigational new drug (IND) application for HLXTE-HAase02, a novel recombinant human hyaluronidase (rHuPH20) injection independently developed and manufactured by the company with proprietary intellectual property rights, has been approved by the China National Medical Products Administration (NMPA). The product is intended to facilitate the dispersion and absorption of subcutaneously administered drugs.
In recent years, the application of large-molecule drugs such as monoclonal antibodies in oncology, autoimmune diseases, and other therapeutic areas has broadened significantly, driving the evolution toward more convenient administration options. Traditional intravenous administration typically requires frequent hospital visits and lengthy dosing times from 30 minutes to several hours.. In contrast, subcutaneous injection can be completed within 2–5 minutes and enables at-home self-administration, markedly improving patient compliance and treatment experience. Since 2014, approvals of subcutaneous formulations have accelerated, accounting for over 30% of FDA-approved antibody drug administration routes by 2024 and establishing subcutaneous administration as the leading alternative to intravenous administration, with substantial market potential. Hyaluronidases play a critical role in this shift by reversibly degrading hyaluronic acid (HA) in the subcutaneous tissue, rapidly reducing tissue viscosity and resistance to enhance drug dispersion and absorption efficiency¹⁻². Among these, rHuPH20 has emerged as an ideal excipient for subcutaneous formulation development due to its lower immunogenicity and sensitization risk³⁻⁴. Currently, several fixed-dose combination products containing rHuPH20 have been approved globally for indications including immunoglobulins, anti-tumor monoclonal antibodies, and neurological disorders.
HLXTE-HAase02 is a next-generation rHuPH20 injection derived from Henlius' proprietary hyaluronidase Henozye®. Henozye® demonstrates excellent enzymatic properties, exhibiting high activity and robust stability across various buffer systems and a wide pH range, along with favorable compatibility with diverse complex molecules. Nonclinical studies show that HLXTE-HAase02 is comparable to an already marketed product (Hylenex) in promoting subcutaneous dispersion and skin reconstitution. Toxicology studies suggest that antibodies generated against rHuPH20 are not associated with related adverse reactions. Furthermore, no significant differences in immunogenicity are observed between subcutaneous and intravenous administration of monoclonal antibodies co-formulated with HLXTE‑HAase02. Currently, Henozye® has been filed as a pharmaceutical excipient with the Center for Drug Evaluation (CDE) in China (Registration No.: F20250000716) and as a Drug Master File (DMF) with the U.S. FDA.
Notably, Henozye® was innovatively designed and developed using the company's proprietary simulation and computing platform, HAI PBD. During the sequence design phase, a Quality by Design (QbD) approach was adopted to purposefully redesign rHuPH20, resulting in a molecule that is significantly distinct from hyaluronidase products currently approved both domestically and internationally. Since 2020, the company's technical operations(TO) team has pioneered the development of its AI for Science platform, integrating cutting-edge technologies such as computational biology, mechanistic modeling, and machine learning with extensive experimental data. This integration has enabled the construction of an in-house AI-assisted simulation and computing platform HAI PBD, which substantially enhances R&D efficiency by covering key processes from protein molecular structure modeling and molecular design to developability assessment, process development, and formulation development. Leveraging this platform, the development cycle of Henozye® has been significantly shortened compared to traditional approaches. The platform also demonstrates broad compatibility with a wide range of protein molecules—including monoclonal antibodies, bispecific antibodies, multispecific antibodies, fusion proteins, and antibody-drug conjugates (ADCs), as well as exceptional stability across diverse buffer systems and environmental conditions. Together, these capabilities lower the barriers for subcutaneous co-formulation development, increase the success rate of complex formulation development, and expand the application scenarios of drug molecules.
Looking ahead, Henlius will continue to consolidate and expand the technological advantages of its chemistry, manufacturing, and controls (CMC) system to support new formulation development, while persistently upgrading its multi-dimensional innovation platform matrix, including the PD-(L)1-centered next-generation immuno-oncology platform, the immune cell engager platform, the Hanjugator™ ADC platform, and the HAI Club. Through this systematic and innovative R&D ecosystem, the company aims to accelerate the development of a mid-to-long-term pipeline with global competitiveness, delivering more high-quality, affordable treatments to patients worldwide.
References
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4. US Food and Drug Administration. Prescribing information. HYLENEX re-combinant (hyaluronidase human injection).