Huons BioPharma Secures NMPA Approval for Type A Botulinum Toxin in China

Huons BioPharma Transferred Exclusive Distribution Rights in China to IMeik in 2022

[Shin-Min Joon, Edaily Reporter] Huons BioPharma a subsidiary of Huons Global has obtained regulatory approval for its botulinum toxin product in China.

Huons BioPharma CI. (Image=Huons BioPharma)

Huons BioPharma announced on the 9th that its Chinese partner IMeik Technology has received marketing authorization from the National Medical Products Administration (NMPA) of China for Hutox (domestic brand name: LIZTOX).

This approval marks the second instance in which a Korean company has secured Chinese regulatory approval for a type A botulinum toxin product.

IMeik acquired exclusive importation and distribution rights for Huons BioPharma’s botulinum toxin products in Greater China including mainland China, Hong Kong and Macau, in 2022. Following the completion of local clinical trials the company submitted a New Drug Application (NDA) in 2024.

Huons BioPharma a specialized botulinum toxin company within the Huons Group was spun off from Huons Global in 2021.

Hutox is a botulinum toxin type A (Clostridium botulinum toxin type A) formulation indicated for both aesthetic and therapeutic use, primarily for the improvement of glabellar lines and periorbital wrinkles.

The active pharmaceutical ingredient is manufactured at high purity and the product’s manufacturing and quality control processes comply with the China Pharmaco poeia ensuring validated quality and consistency.

The 100 unit formulation of Hutox completed a local Phase III clinical trial in China for mod erate to severe glabellar lines. Approximately 17 months after NDA submission in June 2024 the product has now achieved commercial approval.

The Center for Drug Evaluation (CDE) under the NMPA completed its technical review across four key areas clinical data, pharma ceutical quality, statistical evaluation and regulatory compliance. IMeik confirmed that it has received the final drug registration certificate from Chinese authorities.

With this approval Hutox becomes the seventh botulinum toxin product commercially availa ble in China.

Previously approved products include AbbVie’s Botox (U.S.), Lanzhou Institute of Biological Products’ Hengli (China), Ipsen’s Dysport (France), Hugel’s Letybo (Korea), Merz’s Xeomin (Germany), and DaxibotulinumtoxinA (Daxxify) by an Israeli based medical technology company.

More than ten additional domestic and multinational companies are currently con ducting clinical trials or remain in the regulatory review stage in China.

Following approval, IMeik plans to accelerate commercialization through its nationwide distri-bution network in China. The company operates its own dermal filler manufacturing facility and R&D center, enabling a rapid market launch and the establishment of a stable local sup-ply chain.

“We are pleased to begin the new year by sharing meaningful progress toward full-scale en-try into the Chinese market,” said Yeong-Mok Kim, CEO of Huons BioPharma. “Having com-pleted the preparation phase for export, we have now entered a phase of tangible execution, and we expect Hutox to strengthen its global presence.”

He added, “Beyond product competitiveness, our enhanced understanding of global regulato-ry environments and our ability to respond effectively to country-specific requirements have enabled consistent and reliable regulatory submissions. As approvals and supply expansion continue across additional markets, Hutox’s global footprint is expected to further solidify.”

Huons BioPharma has already secured marketing approvals for Hutox in 15 countries, sup-porting steady export growth. In recognition of its performance, the company received the ‘USD 7 Million Export Tower’ award in December last year. Regulatory review processes are currently progressing across key regions, including Latin America, Southeast Asia, and the Middle East, supported by systematic regulatory submissions and technical responsiveness tailored to local requirements.

신민준 (adonis@edaily.co.kr)