“Saturated” is a word often used to describe the Korean botulinum toxin market, which has been dominated by first movers Medytox and Hugel.

But the playing field is about to undergo a major shift, as No. 1 player Medytox faces the possible revocation of its license to sell cash cow Meditoxin.

Anticipating the potential disappearance of Meditoxin, several players are already out to grab a slice of the pie. Hugel, Daewoong Pharmaceutical, Huons, Chong Kun Dang and more are lining up in the growing queue.

Meditoxin is a clostridium botulinum toxin type A that treats issues including facial wrinkles, eyelid twitching and local muscle rigidity in the upper body. It launched in 2006 as the first-ever Korean BTX product. In the 13 years that followed, Medytox sold over 16.9 million vials of Meditoxin, according to the company.

In 2019, the drug accounted for 42 percent of the company’s 205.9 billion won ($167.7 billion) in revenue.

Since April 17, all manufacturing and sales of Meditoxin have been suspended due to allegations that an unapproved material -- the nature of which remains undisclosed -- was used in batches made between December 2012 and June 2015.

The company’s last shot at preventing the revocation of its license to sell the revenue generator was to be Monday’s hearing with the Drug Ministry. The hearing, however, was postponed for an indeterminate time in a surprise twist of events when a Drug Ministry official had a medical emergency.

A new date will be set for the hearing, according to the Drug Ministry and Medytox.

Should the final verdict be unfavorable to Medytox, the company will not be able to apply for reauthorization of the product for at least a year or two, Kim Sang-bong, director of the Pharmaceutical Policy Division at the Ministry of Food and Drug Safety, told The Korea Herald.

Medytox’s stumble is an opportunity for competing BTX makers in the Korean wrinkle-removing beauty market, estimated to be worth some 100 billion won. The global botulinum toxin market is valued at $5.9 billion, and therapeutic formulations account for $3.2 billion, or 55 percent of the total.

Medytox and Hugel are believed to account for approximately 80 percent of the Korean BTX market. The figure is only an estimation, because BTX shots are uninsured items that have no official tally. But rough guesses can be made from the two companies’ annual financial reports.

Hugel, whose BTX product launched in 2009 under the trade name Botulax, posted 204.5 billion won in revenue in 2019, second only by a small margin to Medytox’s 205.9 billion won.

Daewoong Pharmaceutical, whose 2014-launched Nabota is also steadily gaining a stronger footing, is believed to be in third place among Korean BTX products. A rough figure is difficult to gauge, as the firm’s product portfolio goes far beyond the aesthetic BTX and filler market.

Just as Medytox’s shares fell to the lowest level allowed in a day on the Kosdaq bourse on April 20 -- the first business day after the Drug Ministry issued the temporary sales ban -- Hugel’s and Daewoong Pharmaceutical’s soared 16 percent and 10 percent, respectively.

Another product that did not go unnoticed was Huons’ Liztox.

“In light of the developing case, we have switched from Meditoxin to Huons’ product,” said Ban Jae-sang, the chief surgeon at the Banobagi Plastic Surgery Clinic in Gangnam.

Newly launched in mid-2019, Liztox is now to be sold on dual tracks -- traditional pharma firm Chong Kun Dang is to distribute the same product with different packaging under the name Wonder Tox.

Chong Kun Dang said it would mobilize its existing distribution channels and ties to tap the BTX market.

And then there are the newcomers throwing in their hats.

The Drug Ministry refrained from sharing how many new clinical trial applications were made in the BTX arena, citing concerns about stock market fluctuations. But according to publicly accessible data, a number of biotechs are rushing to develop their own BTX products.

Eubiologics was approved on April 22 to carry out a final-stage clinical trial of its BTX pipeline ATGC. Ini Bio is currently recruiting participants for phase 1 and 2 clinical trials of INI 101.

Korea’s oldest pharmaceuticals firm, Dongwha Pharm, and BTX bioventure Jetema announced April 17 that they were collaborating on the development of The Toxin, while Protox has requested Drug Ministry reviews of designs for phase 1 and 2 clinical trials of Protoxin.

Of course, foreign BTX products are silently flexing their muscle in Korea.

Merz’s Xeomin, Allergan’s Botox and Ipsen’s Dysport are viewed positively by consumers here, according to a 2018 report from the Korea Biomedicine Industry Association.

Medytox shares traded on the 300,000 won line just two months ago, but slid to the 200,000 won line at the peak of the COVID-19 crisis and dropped further to the 100,000 won line after sales of Meditoxin were suspended. Within six business days of the sales ban, Medytox shares had fallen 45 percent.

At one point, the company’s market cap plummeted from 1.7 trillion won in February 2020 to 660.5 billion won, tumbling from No. 8 to No. 50 on the Kosdaq.

Individual and foreign investors are still staking their hopes on Medytox, however, as the company continues to sporadically experience marginal rebounds. On Wednesday, Medytox shares went up 6.03 percent to 117,900 won and its market cap rose to 704.7 billion won.

Due to the volatility of the stock, investment analyst Hong Ga-hye of Daishin Securities, who had maintained her recommendation that investors purchase Medytox stocks even after the Meditoxin sale suspension, told The Korea Herald that she had stopped offering any comments on Medytox stocks.

Hong had suggested that Medytox’s China entry would buoy its business performance, and that the business uncertainty would clear up after June 5, when the US International Trade Commission is expected to deliver its preliminary judgment on a case brought by Medytox against Daewoong.

It is still unclear how the revocation of its license might affect Meditoxin’s prospects of market penetration in China. Meditoxin has completed a phase 3 clinical trial.

The Chinese aesthetic treatment market has only two officially authorized botulinum toxin products so far: Allergan’s Botox and Lanzhou Institute’s BTXA. Both products trade at high premium rates.

Not unrelated to the scarcity of options and affordability issue, most of the 2 trillion-won Chinese botulinum toxin treatment market comprises black market goods.

Hence, between Korean BTX companies, the race is for the first to penetrate an untapped China.

Meditoxin was, before the temporary sales ban and legal complexities with Daewoong, considered likely as the first to break through the finish line.

Given the circumstances, Hugel, which has also completed phase 3 clinical trials, might outpace Medytox.

Following close behind, Daewoong Pharmaceutical is currently carrying out clinical phase 3 trials in China, and Huons has recently announced it will begin trials.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)