Huonslab Announces Positive Results from Non-Clinical PK Comparative Study of Trastuzumab Co-formulated with HyDIFFUZE™

- Biological equivalence confirmed to Trastuzumab co-formulated with ENHANZE® -

- Huonslab is advancing with its proprietary antibody SC delivery platform based on recombinant human hyaluronidase PH20  -

Huonslab, a subsidiary of Huons Global Co., Ltd. is accelerating the development of a subcutaneous(SC) injection formulation with recombinant human hyaluronidase (hereinafter “HyDIFFUZE™”) to enhance patient convenience. 

Huonslab announced on the 4th that it has confirmed the non-clinical efficacy of its SC formulation of an antibody drug co-formulated with HyDIFFUZE™ through animal studies conducted by a Contract Research organization (CRO).   

The comparative PK study in animal model was conducted with trastuzumab/HyDIFFUZE™ and trastuzumab/ENHANZE®(Halozyme US). The study results confirmed comparable PK profile and biological equivalence between the two groups.  

HyDIFFUZE had previously demonstrated biological equivalence in comparative studies with MabThera (MabThera® SC, with ENHANZE®) in February and October 2023. Through these studies, HyDIFFUZE™ not only confirmed that HyDIFFUZE provides dispersion efficacy comparable to ENHANZE®, but also secured formulation technology to convert IV drugs into SC formulation applying HyDIFFUZE™ platform.

Last July, Huonslab successfully registered a process patent for the ‘Method for producing original form hyaluronidase’ a method for manufacturing HyDIFFUZE™. This process applies recombinant protein technology using mammalian cell lines (Chinese Hamster Ovary) and HyDIFFUZE™ manufacturing technology to express recombinant human hyaluronidase (rHuPH20) in its original form with high purity and high yield without fragmented byproducts.  

According to a Freedom-to-Operate (FTO) analysis conducted by the law firm PADO IP Law PLLC, Halozyme’s substance patent hyaluronidase is set to expire in September 2027 in the U.S. and in March 2024 in other countries, including S. Korea.   

With the registration of the process patent for its proprietary HyDIFFUZE™ technology, Huonslab anticipates gaining a competitive edge in manufacturing technology and avoiding patent infringement in the global market once Halozyme’s hyaluronidase substance patent expires.   

In August, Honslab received approval from the Ministry of Food and Drug Safety (MFDS) to conduct clinical study for ‘HLB3-002’, a hyaluronidase drug product. This study will evaluate the safety and tolerability of single SC injection in 243 healthy volunteers. 

Lim Chae-Young, a Chief Technology Officer(CTO) of Huonslab Bio Research Institute stated “upon completing the clinical study and obtaining BLA approval from the MFDS, we expect to secure global competitiveness, and marketed in the fields of aesthetics and pain management” He added, “we also plan to broaden the scope of application to various fields such as antibodies, bispecific antibodies, and antibody drug conjugates (ADCs), driving the development of SC drugs that offer great convenience and innovation”.