[Edaily Reporter NA EUN-KYUNG ] A second product is poised to enter the domestic human recombinant hyaluronidase market. While “Tergase Injection” from Alteogen Inc.(196170)holds symbolic significance as the country’s first product, it has been unable to quickly replace existing animal-derived products; now, Huons Co., Ltd.(243070)is stepping up to secure market leadership with its “Hydizyme Injection.” Given that the timing of “Hydizyme”’s approval coincides with Huons Co., Ltd.’s absorption merger of Huons Lab, the product’s initial performance is expected to serve as the first litmus test for gauging the synergies of the merger.

According to Huons Co., Ltd. on the 13th, Huons Lab, the developer of “HeidiZyme,” submitted an application for product approval to the Ministry of Food and Drug Safety last December. The review is currently underway, and the goal is to obtain approval in the second half of this year. Once the merger between Huons Co., Ltd. and Huons Lab is completed, Huons Lab will be dissolved, and the rights to “HeidiZyme,” along with its development and commercialization operations, will be transferred to Huons Co., Ltd., the surviving entity.

Animal-Derived Market Remains Strong Despite the Emergence of Recombinant Products

Hyaluronidase is an enzyme that breaks down hyaluronic acid in tissues to promote the diffusion and absorption of co-administered drugs. It is used in combination with local anesthetics to expand the area of anesthesia or accelerate the onset of action, and is also utilized to treat post-surgical pain and swelling, as well as to alleviate side effects of hyaluronic acid fillers. The domestic market for hyaluronidase monotherapies is estimated to be worth approximately 50 billion won. While the industry previously projected the market would grow to 70 billion won by 2026, this forecast was based on applying a growth rate to existing estimates rather than actual sales figures.

The market is currently dominated by animal-derived products such as Huons Co., Ltd.’s “Hyalajeju.” Alteogen Inc.’s Tergase, which received approval from the Ministry of Food and Drug Safety in July 2024 and was launched in November of the same year, is Korea’s first human recombinant hyaluronidase. The company developed ALT-B4—the core substance of its Hybrozyme technology—into a standalone finished product.

Recombinant products offer the advantage of higher purity and more consistent activity compared to conventional products, which extract enzymes from animal tissues, while also reducing the risk of immune reactions. Alteogen Inc. official explained, “Tergase has high production yield and thermal stability, and it maintains consistent activity while offering higher purity than animal-derived products,” adding, “Clinical trials also confirmed its competitiveness in terms of immunogenicity, as no anti-drug antibodies (ADAs) were detected.”

However, it appears that these technical advantages have not immediately translated into a shift in prescribing patterns. It is presumed that the process of obtaining approval from the pharmacy committees of general hospitals takes time, and it likely also took time to change the usage habits of medical staff accustomed to existing products. In light of this situation, Alteogen Inc. is seeking a turnaround by switching its co-marketer for clinics from PharmaResearch to GC WellBeing this past April.

A GC WellBeing official stated, “We are marketing Tergaz in conjunction with our existing pain management product lineup, including Linex Injection, GC WellBeing Deoxy Injection, and GC WellBeing Collafil.” The official added, “While it is difficult to disclose specific sales figures,” they emphasized that “sales have increased since the change in co-marketer.”

Recombinant products are sold at higher prices than existing products in the non-reimbursed market. The key to market expansion lies in ensuring that healthcare professionals and patients accept the price premium justified by the safety and quality of recombinant products.

Adding a “Premium Product” Based on Hyalase

HyDiZyme was developed based on the wild-type human PH20 amino acid sequence, similar to Halozyme’s “Hylenex.” However, its production process, glycan profile, and formulation differ, making it an independent product rather than a biosimilar of Hylenex. While Hylenex is sold overseas, it has not been launched in Korea; therefore, if HydiZyme is approved, it will split the domestic human recombinant market with Tergase.

A representative of Huons Co., Ltd. explained, “Since we have not conducted direct comparative trials with competing products, it is difficult to definitively determine which product is superior,” but added, “What sets HydiZyme apart is that it is a standalone product based on a wild-type amino acid sequence, not a mutated one.” The official added, “While developing finished products based on our proprietary production and formulation technologies, we are also conducting research and securing patents for the application of subcutaneous injection formulations to various biopharmaceuticals, such as antibody drugs and antibody-drug conjugates (ADCs).”

Group affiliates collaborated on the development and manufacturing processes. Pangen Biotech Inc., a subsidiary of Huons Co., Ltd., produced the active pharmaceutical ingredients (APIs) and conducted process validation and stability testing. Humedix Co., Ltd. was responsible for the finished drug products, performing process validation and stability evaluations. Huons Lab explained that it used this data to compile the Chemistry, Manufacturing, and Control (CMC) documentation, which was incorporated into the marketing authorization application. Regardless of whether the merger between the two companies is finalized, Hy-Dzyme is a key asset that validates both Huons Co., Ltd.’s enterprise value and the rationale for the merger put forward by Huons Co., Ltd.

Of course, there is also the possibility that it could erode existing Hyalase sales. Huons Co., Ltd. also acknowledges that, since the prescription areas and customer bases of the two products overlap to some extent, a certain degree of market shift could occur. However, the strategy is to position Hydi-Zyme as a premium product to expand the market’s reach rather than completely replace existing products.

A Huons Co., Ltd. official emphasized, “The key to expanding the human recombinant hyaluronidase market lies in ensuring that medical professionals fully understand recombinant products and gain sufficient practical experience with them,” adding, “While maintaining the market foundation of the existing Hyalase, we will leverage the Group’s sales and marketing capabilities and network to expand new demand and customer segments in the medical and cosmetic fields.”