BTX market new comers not bothered by legal dispute

MFDS approves BNC Korea and BMI Korea’s botulinum toxin products for export

Including products in development, 18 companies to compete in Korea

The Korean botulinum toxin market competition is reaching the peak.

 

While the toxin strain related legal dispute has not yet been fully resolved, more and more companies are latching on to the market.

 

Bio ventures, on top of the large and small-and-medium companies, have announced their plan to join the over-heated competition.

 

On Jan.

 

13, Ministry of Food and Drug Safety (MFDS) cleared two botulinum toxin items, ‘Bienox’ and ‘Hitox,’ respectively from BNC Korea and BMI Korea.

 

Founded in 2007, BNC Korea specializes in aesthetic plastic surgery medical devices like dermal filler and hyaluronic acid filler.

 

Established in 2005, BMI Korea is the only pharmaceutical company to base in Jeju Island.

 

It has been mainly manufacturing injections for anesthesia and pain.

 

It seems their strategy is to first receive approval as an export product, and to win sales approval in Korea after conducting clinical trial in the future.

 

With the export approval, the companies may export the products overseas without marketing approval in Korea.

 

The strategy has worked for Huons, when its botulinum toxin product first got cleared for export under the name of ‘Hutox’, and received approval for Korean market later under the name of ‘Liztox.’ Including BNS Korea and BMI Korea, now 12 pharmaceutical companies have Korean government-approved botulinum toxin products.

 

The number goes down to eight, excluding importers like Allergan, Merz and Ipsen.

 

The rest of the list consists of Medytox, Hugel, Daewoong Pharmaceutical, Huons, Pharma Research Bio, Chong Kun Dang Pharmaceutical, BNC Korea and BMI Korea, in the order of approval date.

 

Botulinum toxin products approved by MFDS

The list expands to 18 companies if companies with botulinum toxin in development are added.

 

All the latecomers are new bio companies, such as Jetema, Protox, Kanzen, Eubiologics, and Inibio.

 

According to sources, Jetema has recently applied for MFDS’ export approval.

 

The company has been approved as a pharmaceutical manufacturing company in January 2019.

 

The purpose of the company seems to be clear and focused on manufacturing botulinum toxin products.

 

On the other hand, Protox completed the construction of its botulinum toxin production facility in Hyangnam Pharmaceutical Industry Cluster in Hwaseong, Gyeonggi Province.

 

The facility has a capacity to manufacture approximately 2.7 million vials a year.

 

The company plans to conduct Phase 1 trial this year on its independently developed product, ‘Protoxin.’ Eubiologics and Inibio had their clinical trial protocols passed in March and December last year, respectively.

 

Kanzen has registered botulinum toxin strain discovered on a snow mountain.

 

Botulinum toxin products in development

As a result, an unprecedentedly intense competition is expected to unfold in Korea.

 

Currently, there are about three to seven global pharmaceutical companies supplying botulinum toxin products.

 

Starting from Allergan, Ipsen and Merz, other global companies like Galderma, US WorldMeds, Revance Therapeutics and Lanzhou Bioengineering are in the game.

 

In around 2022 and 2023, at least 14 companies would be competing against each other with 16 items according to the companies’ development plans.

 

As blunt as it is, the competition would inevitably do more damage.

 

The market, once led by Medytox and Hugel, has gotten saturated with Daewoong Pharmaceutical and Huons joining the market.

 

Sources confirmed Medytox and Hugel have stopped growing already.

 

Also the unresolved legal dispute over the source of botulinum toxin strain could be a burden for the new challengers.

 

At the moment, Medytox and Daewoong Pharmaceutical are preceding astronomically expensive litigation on the source of botulinum toxin strain.

 

The litigation would get close the final decision in around June.

 

An insider of the industry commented, “Depending on the final decision, the two companies may proceed with next litigation.”