Huons Biopharma Receives Approval for Type A Botulinum Toxin in China

Second Korean Company to Receive Approval for Botulinum Toxin in China

Huons Biopharma, a subsidiary of Huons Global, has received product approval for its botulinum toxin in China.

Huons Biopharma

On January 9, Huons Biopharma announced that its Chinese partner, iMaker Technology (iMaker), has obtained registration approval for "Hutox" from the National Medical Products Administration (NMPA) of China. This product approval marks the second case in which a Korean company has received approval for type A botulinum toxin in China.

Previously, in 2022, iMaker acquired exclusive import and distribution rights for Huons Biopharma's botulinum toxin products in the Chinese region, including Macau and Hong Kong. After completing local clinical trials in China, the company applied for product approval in 2024.

Hutox is a pharmaceutical product for cosmetic and therapeutic use, with botulinum toxin (Clostridium botulinum toxin type A) as its main ingredient. It is primarily used to improve glabellar lines and crow’s feet. The key component, botulinum toxin type A, has been proven to be manufactured and quality-controlled in accordance with the Chinese Pharmacopoeia.

Hutox 100 units completed a phase 3 clinical trial in China for the improvement of moderate to severe glabellar lines, and commercialization in China was achieved approximately one year and seven months after submitting the New Drug Application (NDA) in June 2024. The Center for Drug Evaluation (CDE) under the NMPA completed technical reviews of Hutox in four areas: clinical, pharmaceutical, statistical, and regulatory compliance.

Hutox has become the seventh botulinum toxin to be commercialized in China. The six other botulinum toxin products approved for sale in China are: "Botox" by AbbVie (USA), "Hengli" by Lanzhou Biotechnique (China), "Dysport" by Ipsen (France), "LetibotulinumtoxinA" by Hugel (Korea), "Xeomin" by Merz (Germany), and "DaxibotulinumtoxinA" by Sisram Medical Technology (Israel).

Following this product approval, iMaker plans to accelerate commercialization of the product throughout China using its established nationwide network. With its own filler manufacturing plant and research institute, the company aims to quickly launch the product in the market and establish a stable supply system locally.

Kim Youngmok, CEO of Huons Biopharma, stated, "I am pleased to share the news that we are officially entering the Chinese market in the new year. Until now, we have been in the preparation phase for exports, but as we move into the tangible phase, I look forward to Hutox making its mark globally."