[Edaily Reporter NA EUN-KYUNG ] Newmeco, a subsidiary of Medy-Tox Inc.(086900), announced on the 22nd that it has obtained marketing authorization from the Ministry of Food and Drug Safety for its botulinum toxin product “Newlux Injection 200 Units” (Clostridium botulinum toxin type A).

With this approval, Newmeco has expanded its product lineup to include the 200-unit formulation, following the “Newlux Injection 100 Units” approved in 2023.

Botulinum toxin is a biopharmaceutical used not only for cosmetic indications, such as glabellar lines, but also for various therapeutic purposes, including muscle stiffness and blepharospasm. In the domestic market, companies such as Medy-Tox Inc., Hugel, Inc.(145020), DAEWOONGPHARMACEUTICAL(069620), and Huons Co., Ltd. are competing, and there has recently been active diversification of product lines to expand into overseas markets.

Newlux is a freeze-dried botulinum toxin product developed by Newmeco based on a candidate substance for which it received a technology transfer from Medy-Tox Inc. According to the company, only non-animal-derived media were used during the bacterial strain cultivation process, and the manufacturing process was also partially improved.

Newlux 200 Units has the same efficacy and effects as the existing 100-unit product but contains twice the active ingredient. The company explains that it can be used in procedures or treatment settings requiring high doses and will expand the range of dosage options available to medical professionals.

The product is scheduled to be manufactured at Building E of Medy-Tox Inc.’s Osong Plant No. 3.

A NewMeco official stated, “Based on this domestic marketing authorization for the 200-unit product, we have laid the groundwork to enhance our competitiveness in future global regulatory approvals and exports,” adding, “We will continue to elevate the brand value of ‘NewLux’ by leveraging our differentiated quality competitiveness and R&D capabilities.”