Alteogen Gets MFDS Approval for Tergase®

Alteogen Inc., a biopharmaceutical company based in Daejeon, South Korea, has announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved their New Drug Application (NDA) for Tergase®, a recombinant human hyaluronidase. This approval marks a significant achievement for Alteogen as it steps into the commercial stage of its operations, aiming to deliver improved biologic products for patients.

Tergase® is developed using Alteogen's Hybrozyme™ Technology and is primarily intended for the removal of dermal fillers. However, its applications extend to various medical fields, including providing local anesthesia for eye surgeries and managing orthopedic pain. Unlike the existing market hyaluronidases, which are typically derived from bovine or ovine sources and have lower purity levels, Tergase® boasts over 99% purity and reduced immunogenicity due to its recombinant nature. This high purity level suggests that Tergase® could be used in areas where animal-derived hyaluronidases have not been traditionally utilized.

The submission for NDA approval was backed by a pivotal Phase 1 clinical trial conducted across multiple centers. This double-blind, placebo-controlled study involved 244 healthy participants to evaluate the safety, tolerability, and pharmacokinetics of Tergase®. The trial successfully met its primary endpoint, demonstrating a significantly lower allergic response rate during intradermal administration compared to the U.S. Food and Drug Administration's (USFDA) recommendations. Additionally, no anti-drug antibodies (ADA) were detected in the test subjects.

The MFDS approval is a crucial step for Alteogen, enabling the company to move forward with its commercial strategies. Dr. Soon Jae Park, CEO of Alteogen, expressed enthusiasm over this milestone and the potential for expanding partnerships to commercialize Tergase®. He emphasized that Tergase®'s excellent safety profile, compared to animal-derived hyaluronidase products, positions it as a competitive alternative in the global hyaluronidase market, which is projected to reach around $1 billion.

Tergase® (ALT-BB4), a standalone recombinant hyaluronidase derived from human hyaluronidase PH20, is being explored for a broad spectrum of uses. Its primary function is to act as a tissue permeability enhancer, facilitating the dispersion and absorption of other injected drugs and topical anesthetics when administered subcutaneously or intradermally. The product is designed to balance efficacy and safety optimally and is available in a liquid formulation free from human serum albumin, with a concentration of 1,500 IU/mL per vial.

Alteogen Inc., founded in 2008 and listed on the KOSDAQ, specializes in developing and commercializing innovative biologics, including Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Its portfolio features clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed using its proprietary NexP™-fusion and NexMab™ platform technologies. Additionally, Alteogen has engineered a proprietary recombinant human hyaluronidase enzyme through its Hybrozyme™ technology, which enables the subcutaneous administration of large drug volumes typically given via intravenous infusion.

In summary, the approval of Tergase® by the MFDS represents a pivotal achievement for Alteogen, setting the stage for the product to make a significant impact in the global hyaluronidase market and enhancing the company's commercial prospects.