ALTEOGEN Inc. announced that the Ministry of Food and Drug Safety (MFDS) of Korea approved its New Drug Application (NDA) for Tergase® (recombinant hyaluronidase). Tergase® is a recombinant human hyaluronidase developed utilizing Alteogen's proprietary Hybrozyme? Technology.

Dermal filler removal is the main product application, but it can also be used for various purposes, including local anesthetic solution for eye surgery, and orthopedics pain management. Mainly bovine or ovine-derived hyaluronidases with lower purity levels are available on the market, whereas owing to its recombinant source, Tergase® exhibits over 99% purity with lower immunogenicity. Given the superior product profile and comparative advantages, it is expected that the product applications will be extended to fields where animal-origin hyaluronidases have not been traditionally used.

The NDA submission is supported by a multicenter, 2-arm, randomized, double-blinded, placebo-controlled pivotal Phase 1 clinical trial involving 244 healthy subjects for the assessment of safety, tolerability, and pharmacokinetic characteristics. Primary endpoint - drug allergy response during intradermal administration ? was met as the allergic response rate in the test group was significantly lower than the U.S. Food and Drug Administration (USFDA) recommendation as well as zero incidence of anti-drug antibodies (ADA) found.

MFDS approval of Tergase® marks a key milestone for Alteogen as it transitions to become a commercial-stage company and achieves its goal of delivering better biologics for patients.