Alteogen's 'Hyaluronidase Alone' Tergase Approved by MFDS

Alteogen announced on the 8th that its recombinant hyaluronidase standalone product, Tergase, received marketing approval from the Ministry of Food and Drug Safety on the 5th.

Alteogen's hyaluronidase standalone product 'Tergase'

Tergase is a product that uses recombinant hyaluronidase (ALT-B4) made with Alteogen's Hybrozyme technology as a standalone. ALT-B4 is a core technology of Alteogen that converts existing intravenous injection formulations into subcutaneous injection formulations, enhancing dosing convenience. ALT-B4 is a platform technology for which multiple global pharmaceutical companies have signed technology export contracts, and worldwide, only Halozyme in the United States and Alteogen possess it.

The standalone hyaluronidase product is used in orthopedics, neurosurgery, anesthesiology, and rehabilitation medicine to manage pain or swelling or to accelerate drug absorption. It is also known to enable faster anesthesia and accelerate wound healing compared to the conventional lidocaine-only method in trauma and post-surgical suturing. Additionally, in the cosmetic field, it is rapidly expanding into various areas such as fat-dissolving injections and correction after filler use.

The company explained that Tergase can have an advantage in quality compared to existing products. First, it is considered to have higher safety in terms of the origin of its ingredients. Existing hyaluronidase products are animal-derived, produced by extracting from the testes of animals such as horses or sheep. This raised concerns about allergic side effects caused by administering heterologous proteins different from the human body. In contrast, Tergase is a human-derived product that significantly reduced such safety concerns in clinical trials, and notably, it was proven that anti-drug antibodies (ADA) do not occur, allowing for repeated procedures.

Park Soon-jae, CEO of Alteogen, said, “Marketing and sales of Tergase are very different fields from the culture that Alteogen has maintained and developed, focusing on research and development (R&D) of biopharmaceuticals.” He added, “To maintain Alteogen’s expertise and identity and achieve efficient performance, we will conduct the Tergase business through our subsidiary, Alteogen Healthcare.”

This content was produced with the assistance of AI translation services.