Huons BioPharma, a subsidiary of Huons Global, said on the 9th that its type A botulinum toxin product has received marketing authorization in China.
IMeik Technology, Huons BioPharma's partner in China, obtained drug registration approval for "Hutox®" from China's National Medical Products Administration (NMPA). The product's name in Korea is "LIZTOX." This approval is the second case of a Korean corporations successfully entering the Chinese market with a type A botulinum toxin.
IMeik secured exclusive import and distribution rights for Hutox in China (including Macao and Hong Kong) from Huons BioPharma in 2022. It later completed clinical trials in China and applied for marketing authorization in 2024.
Huons BioPharma is a botulinum toxin specialist corporations spun off from Huons Global in 2021. Its flagship product, Hutox, is a cosmetic and therapeutic drug whose main ingredient is botulinum toxin type A (Clostridium botulinum toxin), used to improve glabellar lines and crow's feet. It is manufactured and quality-controlled in accordance with the China Pharmacopoeia, and is characterized by the use of high-purity botulinum toxin type A.
Hutox Injection 100 units completed phase 3 clinical trials in China for the indication of improving moderate to severe glabellar lines. About 1 year and 7 months after applying for marketing authorization in June 2024, commercialization has become possible. With this approval, Hutox Injection has become the seventh botulinum toxin product commercialized in China.
Botulinum toxin products approved for sale in China include "Botox" by U.S. company AbbVie, "Hengli" by China's Lanzhou Biotech, "Dysport" by France's Ipsen, "Letybo" by Korea's HUGEL, and "Xeomin®" by Germany's Merz, among others, and more than 10 other Chinese and overseas corporations are in clinical or approval procedures.
IMeik plans to ramp up market supply of Hutox by leveraging its distribution network established across China. Based on its own filler manufacturing plant and research lab, it aims for a fast market launch and a stable supply system.
So far, Huons BioPharma has obtained marketing authorization for Hutox in 15 countries and exported it. Additional national approvals are underway, focusing on Latin America, Southeast Asia and the Middle East.
Chief Executive Kim Young-mok of Huons BioPharma said, "We achieved a meaningful result as our entry into the Chinese market moves into full swing," adding, "We have moved beyond the preparation stage centered on approvals and entered a phase where tangible results are becoming visible." Kim added, "As our ability to respond to regulatory requirements by country accumulates, the foundation for expanding into global markets is strengthening."