The number of domestic companies producing botulinum preparations used for cosmetic purposes such as wrinkle improvement is increasing. This agent, famous as Allergan’s ‘Botox’, is currently being competed with by domestic companies such as Medytox, Daewoong Pharmaceutical, and Hugel by launching products into the market.

According to the Ministry of Food and Drug Safety on the 11th, Protox (CEO Lee Dong-beom), which is developing botulinum toxin preparations, obtained a pharmaceutical manufacturing license on the 7th.

Protox completed the construction of a botulinum toxin plant last April, investing 32 billion won. The factory is located in Hyangnam Pharmaceutical Complex, Hwaseong-si, Gyeonggi-do.

This factory has a total floor area of ​​6,227㎡ (about 1,886 pyeong), 4 floors above ground, and is equipped with GMP (good manufacturing practice) facilities.

The company said that it can produce 2.7 million vials of botulinum toxin preparations per year, and that it is conducting a redesign to install additional freeze dryers to increase production to 5.4 million vials per year in the future.

It is known that ‘Protoxin’, a botulinum toxin A preparation currently being developed by Protox, has completed non-clinical trials and is preparing for clinical trials. The company explained, “We are developing a high-purity, next-generation botulinum toxin preparation with improved formulation and performance compared to existing botulinum toxin preparations,” and added, “We are aiming to launch the product in 2023, starting with clinical trials next year.”

Protox is a subsidiary of DSK, a factory automation control system developer. Protox is also the largest shareholder of pharmaceutical company Medica Korea with a 49.47% stake.

As domestic botulinum toxin preparations become success stories, such as Medytox and Hugel’s high domestic market share and Daewoong Pharmaceutical’s overseas expansion, the number of next-tier players such as Protox continues to increase. Companies currently developing botulinum toxin preparations include Eubiologics, Protox, BMI Korea, Zetema, Kanzen, and Osstem Implant.

Huons Global also received approval for ‘Riztox Injection’ in 2016, and Pharma Research Bio also received approval for ‘Reentox Injection’ in February, and is preparing to launch it on the market. Now there are five licensed companies. Latecomers dream of becoming the next Medytox, Daewoong Pharmaceutical.
Reporter Tak-soon Lee (hooggasi2@dailypharm.com)