[Asia Economy Reporter Chunhee Lee] Alteogen announced on the 8th that it had applied for product approval of the recombinant hyaluronidase standalone product ‘Tergase’ to the Ministry of Food and Drug Safety on the 7th. This came just over two months after receiving the clinical trial report (CSR) for Tergase in December last year.
Tergase is a recombinant hyaluronidase standalone product developed by Alteogen. The hyaluronidase used in Alteogen’s subcutaneous injection (SC) formulation change platform ‘Hybrozyme’ is currently used for treating side effects of hyaluronic acid fillers, as an ophthalmic surgery adjunct, and for pain relief.
In the domestic market, which Alteogen considers its first target, only animal-derived hyaluronidase products exist. Since hyaluronidase is extracted and produced from the organs of cows or sheep, most have low purity, but Tergase is a high-purity product produced through protein recombination, according to the company. Therefore, it shows effects even with small amounts used, and the possibility of immunogenicity or other side effects is significantly reduced. Furthermore, when clinical results were compared with competing products, Tergase demonstrated safety by showing lower injection-related side effects (IRS) even when administered intradermally at 4 to 20 times the drug amount.
An Alteogen official said, “We prepared the application while discussing with clinical researchers to ensure smooth product approval,” adding, “If we obtain product approval within this year as planned, we intend to enter various markets starting with the domestic market.”
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