Alteogen said its recombinant hyaluronidase product, Tergase (ALT-B4), has received marketing authorization from the Ministry of Food and Drug Safety (MFDS).

Tergase, developed using Alteogen's Hybrozyme technology, is a recombinant hyaluronidase product that is utilized independently.

The Korean hyaluronidase product market, currently estimated at approximately 1 trillion won ($ 725.4 million), finds applications across various fields, including orthopedics, neurosurgery, anesthesiology, and rehabilitation medicine. It is primarily used to manage pain and swelling or to accelerate drug absorption.

Unlike existing hyaluronidase products, which are derived from the testes of animals such as cows or sheep, Tergase is a non-animal recombinant product.

According to Alteogen, traditional animal-derived hyaluronidase products have raised concerns regarding product quality and allergic reactions due to the administration of heterologous proteins.

The company stressed that clinical trials have shown that Tergase significantly reduces these safety concerns, notably by not inducing anti-drug antibodies (ADA), thereby allowing for repeated administration.

The company believes that Tergase's superior quality will rapidly transform the current market as it has the potential enter various therapeutic markets which were previously unattainable due to the side effects of animal-derived hyaluronidase products.

"Marketing and sales of our first commercial product, Tergase, represent a new venture for Alteogen, which has primarily focused on R&D of biopharmaceuticals," Alteogen CEO Park Soon-jae said. "To maintain our expertise and identity while achieving efficient performance, we will conduct the Tergase business through our subsidiary, Alteogen Healthcare, which specializes in this field."

Meanwhile, Park stressed that Tergase has already garnered significant interest in international meetings, such as CPHI and BIO USA, with agreements to discuss commercialization post-approval.

Alteogen and Alteogen Healthcare plan to target key markets in Europe, the U.S., and South America, considering each region's unique product classification, regulatory frameworks, and indications for effective international expansion.