Alteogen’s Tergase® Shines with Outstanding Immunogenicity Profile in Breakthrough Injection

Alteogen’s Tergase® Breaks Ground with Zero Immunogenicity in Clinical Triumph

DAEJEON, South Korea, September 5, 2023 – Brace yourselves for a medical marvel! Alteogen Inc. (KOSDAQ:196170), a pioneering Korean biotech firm, has unveiled a groundbreaking discovery in their recent clinical trial of Tergase®. The showstopper? Zero incidence of ADA (including neutralizing antibodies), an unprecedented feat that could revolutionize the medical world.

Tergase®, Alteogen’s trailblazing creation, isn’t your average hyaluronidase product. It’s poised to replace animal-derived counterparts, complete with their notorious disadvantages. Unlike its commercial counterparts, Tergase® showed absolutely no sign of anti-drug antibodies (ADA) in the clinical trial—a game-changer in terms of both safety and effectiveness.

What makes Tergase® extraordinary? It’s a standalone hyaluronidase product designed to tackle various medical conditions, from pain relief to edema treatment and even hyaluronic acid filler removal. But here’s the kicker—compared to the animal-derived competition, it’s a pinnacle of purity with minimal impurities and an impeccable safety record. As a Novel Recombinant Human Hyaluronidase, Tergase® has the potential to open doors to new indications currently out of reach for existing animal-derived products.

ADA, the proverbial villains in the world of drugs, are notorious for inducing unwanted side effects. Regulatory authorities scrutinize products for ADA presence, knowing it can impact safety and efficacy. With Tergase®, a genetically modified human recombinant protein crafted through cutting-edge domain swapping technology, a low incidence of ADA was always expected. The clinical trial’s stunning result—zero ADA incidence among 244 healthy volunteers—solidifies Tergase®’s position as a top-tier product due to its exceptional quality.

Dr. Soon Jae Park, CEO of Alteogen, underscores the need for differentiated, safer products in the market. Existing animal-derived options have limitations due to their side effect profiles, making Tergase® a game-changer in terms of stability and safety. It’s even poised to outshine the only commercially available human recombinant hyaluronidase from Alteogen’s competitor.

Intriguingly, a literature review unveiled ADA incidence ranging from 3% to 12% in the competitor’s recombinant hyaluronidase product. Even more impressive, administering Tergase® at a 4-20 times higher dosage than the competitor resulted in significantly fewer Injection Site Reactions (ISRs).

Currently, Tergase® is navigating the pharmaceutical approval process by the Ministry of Food and Drug Safety, with expectations of product approval by the end of 2023 or early 2024. The world of medicine is on the cusp of a transformative breakthrough, and Alteogen’s Tergase® is leading the charge.

About Alteogen Inc.

DAEJEON, South Korea – Alteogen Inc. is not your run-of-the-mill biopharmaceutical company. It’s a South Korea-based trailblazer, dedicated to pushing the boundaries of medical innovation. At its core, Alteogen is all about developing and commercializing groundbreaking biologics. Think Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars—the kind of revolutionary therapies that are shaping the future of healthcare.

What sets Alteogen apart is its impressive portfolio, brimming with clinical-stage long-acting therapeutic proteins and next-gen ADCs. These scientific marvels are the result of proprietary NexP™-fusion and NexMab™ platform technologies, representing the cutting edge of biopharmaceutical R&D.

But that’s not all. Alteogen’s ingenuity doesn’t stop there. They’ve harnessed the power of Hybrozyme™ technology to create a game-changing proprietary recombinant human hyaluronidase enzyme. This innovation opens the door to large-volume subcutaneous drug administration—typically reserved for IV injections. It’s a game-changer, breaking barriers in drug delivery.

Founded in 2008, Alteogen Inc. has risen to prominence and is now listed on KOSDAQ (196170.KQ). This is a company with a mission: to revolutionize medicine, one breakthrough at a time. Stay tuned, because Alteogen is shaping tomorrow’s healthcare solutions today.

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