Medytox received approval of the world’s first liquid-type BTX ‘INNOTOX® 100 unit’ in domestic market from MFDS
- With the approval, Medytox secured its lineup of various capacities along with 25, 50 units…dominating the premium BTX market in advance.
- The utilization rate of Medytox’s 2nd plant under cGMP guidelines has increased.
SEOUL, SOUTH KOREA – January, 2020 – INNOTOX® 100 unit received approval in domestic market manufactured in Medytox’s second plant designed to meet cGMP of US FDA.
Medytox Inc., the leading biopharmaceutical company in Korea, said on January 2 that the Ministry of Food and Drug Safety has approved to sell INNOTOX® 100 unit, the world’s first liquid-type botulinum toxin (BTX) A-Type product, in the domestic market. With this approval, Medytox has secured its lineup of various capacities along with the existing 25 and 50 units. Also Medytox has increased the utilization rate of its second plant in Osong, which exclusively manufactures BTX products under U.S. current Good Manufacturing Practice (cGMP) guidelines.
INNOTOX® is the world’s first liquid type BTX A-type developed by Medytox in 2014. It enhances safety by eliminating both human serum albumin and animal-derived substances in the manufacturing process. Also INNOTOX® can be used immediately without any dilution process, further improving the convenience of treatment and having the advantage of more accurate treatment capacity calculation.
«The sales approval for INNOTOX® 100 unit is significant as it has allowed the company to secure a lineup of various capacities, and help to meet consumer needs better,» Medytox CEO Hyunho Jung said. «Clinical trials are underway to secure additional indications for INNOTOX® and accelerate the company’s advance to the premium BTX market.» The company also plans to unveil a new prefilled syringe-type BTX, Jung said.
Meanwhile, Medytox signed a partnership with Allergan, the original manufacturer of Botox, in 2013 to bring BTX to the advanced market. Recently, Allergan initiated phase 3 clinical trials in both US and EU with hopes to get US marketing approval in 2022.