Small and mid-size domestic companies are rushing to develop botulinum toxin products, and four of them won approvals to conduct clinical trials for new anti-wrinkle treatments this year.
Ini Bio said Tuesday the Ministry of Food and Drug Safety gave the go-ahead to phase-1/2 trial on its botulinum toxin, INI-101. The study will compare the safety and efficacy of INI101 and botox strains in improving moderate or severe frown lines between eyes in adult patients.
Ini Bio and three other companies are testing their botulinum toxin candidates this year.
In January, Pharma Research Bio received approval for a phase-1 trial on ReNTox, a botulinum toxin type A that the company developed. In March, EuBiologics followed suit with a phase-1/2 on ATGC-100, a new botulinum toxin being developed jointly with ATGC. In August, BMI Korea also announced that it received the nod to test “Hitox,” a botulinum toxin type A, in a phase-1/2 trial.
The four companies are expected to enter the botulinum toxin market in 2022 or 2023, where more newcomers will arrive.
Next year, at least three drugmakers are likely to join the botulinum toxin competition.
Protox and Jetema have completed the construction of botulinum toxin manufacturing plants in Hwaseong in Gyeonggi Province and Wonju in Gangwon Province, respectively. They plan to begin testing their products next year. Another biotech firm Kanzen also said it discovered a strain of botulinum toxin in March and scheduled a trial for next year.
The problem, however, is that the domestic botulinum toxin market is already saturated, and the players would have to lower prices to compete.
Local companies such as Hugel, Medytox, and Daewoong Pharmaceutical are leading the local botulinum market. As most of the products aim for cosmetic purposes, a domestic firm selling products at a lower price is more likely to secure a larger market share.
Huons joined the market with the launch of Liztox in June, and Chong Kun Dang will do so next year. Chong Kun Dang recently signed an agreement to get a supply of the raw material of Liztox from Huons. Chong Kun Dang is expected to roll out a botulinum toxin, under the brand name Wonder Tox, as early as in March next year.
Chong Kun Dang has experience of selling Hugel’s botulinum toxin. The company is likely to be more aggressive in marketing a new botulinum toxin because it earned direct sales rights through the latest agreement with Huons.