Did you know that 9.8 million botulinum toxin type A injections were administered in the United States in 2024? According to the American Society of Plastic Surgeons’ (ASPS) Procedural Statistics Report, this procedure became the most popular non-surgical cosmetic procedure of the year. This widespread use underscores the importance of ensuring product consistency and safety in such high-demand treatments.
Given the growing popularity of botulinum toxin products, practitioners need to partner with a reliable manufacturer. Liztox, a botulinum toxin type A formulation, is produced by Huons Biopharma Co., Ltd. This respected South Korean biotech company is recognized for its GMP-certified facilities, rigorous quality controls, and global distribution network. These attributes ensure batch-to-batch reliability, making Liztox a trusted option for medical professionals looking to deliver consistent, safe results.
In this article, we’ll delve into Huons Biopharma’s corporate background, manufacturing processes, and quality assurance practices, explaining why Liztox stands out in the world of botulinum toxin products.
Key Takeaways
- Huons Biopharma Co., Ltd. is a leading South Korean biotech firm specializing in the development and production of botulinum toxin products like Liztox for both therapeutic and aesthetic uses.
- Liztox received approval from various regulatory bodies, including Thailand’s FDA in 2023 and Iraq’s Ministry of Health in 2019. It is set to launch in Europe under the name Hutox.
- Huons Biopharma operates GMP-certified facilities and undergoes annual inspections by the MFDS. This ensures adherence to the highest standards in hygiene, staff training, and quality assurance.
- The development of Liztox involved significant milestones, including the first MFDS approval for a locally produced botulinum toxin in 2019 and ongoing trials for new indications, such as post-stroke upper limb spasticity and square jaw correction.
- Clinics rely on Liztox for its proven efficacy, supported by randomized trials that demonstrate non-inferiority to Botox in treating conditions such as upper-limb spasticity.
- Huons Biopharma is committed to global expansion, actively pursuing new markets and building partnerships to provide high-quality aesthetic and therapeutic solutions worldwide.
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The Origins and Growth of Huons Biopharma
Huons Global established Huons Biopharma Co., Ltd. as a subsidiary specializing in the development and production of botulinum toxin. Led by CEO Yeong Mok Kim, this South Korean-based company is part of a larger healthcare group that focuses on pharmaceuticals, aesthetics, and innovative medical devices.
Founded in 1965 as Gwangmyeong Pharmaceutical Company, the company obtained its Korea Good Manufacturing Practice (KGMP) certification in 1993. In 1998, Huons developed Korea’s first plastic container injection (patent no. 0381404) and established an affiliated research center.
Further advancing its capabilities, the company received ISO9001 certification in 2003, at which point it also changed its name to Huons Co., Ltd. Since then, Huons Biopharma has focused on:
- Developing botulinum toxin products (e.g., Liztox) for therapeutic and aesthetic use
- Providing Contract Manufacturing Organization (CMO) services
- Engaging in the research and development of biopharmaceuticals
Huons contributes to South Korea’s pharmaceutical innovation by:
- Ramp-up local manufacturing of life-critical injectable medicines to prevent shortages in hospitals and clinics.
- Expanding global access to cutting-edge aesthetic and therapeutic solutions by exporting to international markets.
- Elevating biopharmaceutical production quality through state-of-the-art, GMP-certified facilities that meet the strictest global standards.
How Huons Innovated in Botulinum Toxin with Liztox Product
The development of Liztox began at Huons’ dedicated biologics division, Huons Lab. This marked a significant milestone for South Korea, as Liztox became the first locally produced botulinum toxin to receive approval from the Korean Ministry of Food and Drug Safety (MFDS) in April 2019.
By June 2019, Liztox inj was launched across Korea for both aesthetic refinements and therapeutic treatments. This makes it a groundbreaking achievement in domestic toxin manufacturing. By November 2020, Phase I trials confirmed the safety and tolerability of Liztox in healthy participants.
In mid-2021, Liztox entered a Phase III study, evaluating its use for post-stroke upper-limb spasticity, which broadened its therapeutic applications beyond cosmetic treatments. By early 2022, Phase II results showed promising efficacy in reducing benign masseteric hypertrophy, further expanding its clinical utility. In March 2023, Huons filed an IND for a Phase III trial targeting square-jaw Liztox correction.
Huons optimized product purification methods to ensure a highly purified product with reduced immunogenicity. By improving stability and minimizing risks associated with clostridium botulinum type A proteins, the company has achieved an international standard of safety and consistency in toxin production.
Regulatory Standards and Manufacturing Protocols of Product Units
Huons Biopharma has earned Korean Good Manufacturing Practice (KGMP) certification from the Ministry of Food and Drug Safety (MFDS) for its Hutox plant, which also manufactures Liztox. Every year, MFDS inspectors audit the facility to ensure it adheres to the highest standards for hygiene, record-keeping, and staff training.
To ensure Liztox product remains available on the market without interruption, Huons holds an active Pharmaceutical Manufacturing License. This is renewed every two years. At every stage of Liztox production, Huons enforces a robust quality-assurance program, including:
- In-process testing of protein concentration and pH levels
- Sterility and endotoxin assays before vial filling
- Long-term stability studies in accordance with ICH guidelines
- Final release only after a comprehensive multi-disciplinary quality review
These safeguards ensure every vial of Liztox units maintains its purity level and therapeutic reliability, making it suitable for wrinkle correction.
Global Expansion and Where Liztox Fits In
While Liztox is not yet approved by the US FDA, medical professionals in regions where it has received approval should ensure they know how to administer Liztox properly. Training in dosing units, preparation, and potential risks is crucial to optimizing its use in patients.
Huons Biopharma accelerated its global rollout by renaming Liztox as Hutox for export markets. In 2016, the company hit a $30 million export milestone and received the Export Tower Award. Since then, Huons has secured key regulatory approvals, including:
- Iraq’s Ministry of Health approval in 2019
- Thailand’s FDA clearance in 2023
- An exclusive licensing and supply deal with HAEMATO in 2021 to introduce Hutox to Europe, with marketing-authorization preparations underway.
Huons’ strategy to expand its botulinum toxin lineup is clear. They also have plans to broaden their reach in the world’s leading aesthetic markets.
The Trust Factor for Clinics Using Liztox
When choosing a botulinum toxin, clinics look for highly purified botulinum toxin products with manufacturers prioritizing stringent quality systems. The Korean GMP certification and annual MFDS inspections prove that Liztox correction meets the highest standards in hygiene practices, documentation accuracy, and staff training.
In a randomized, double-blind Phase 3 trial, Liztox inj demonstrated non-inferiority to onabotulinum toxin A (Botox®) for post-stroke upper-limb spasticity, matching safety and efficacy endpoints. Its export data and regulatory approvals from various regions reflect its growing global footprint and credibility within the industry.
The growing network of global approvals, combined with its purity level and product purification process, strengthens Liztox’s reputation as a reliable choice for both wrinkle treatment and complex therapeutic indications.
Conclusion
Huons Biopharma Co., Ltd. stands out as a leading manufacturer of botulinum toxin products, such as Liztox. They ensure quality and safety through rigorous manufacturing practices and strict compliance with regulatory standards. Moreover, the development of Liztox reflects their commitment to innovation, from its initial drug approval to its expansion into new therapeutic areas.
As the market for non-surgical cosmetic procedures continues to grow, healthcare professionals can confidently rely on Huons for consistent and effective solutions. By focusing on quality assurance and global expansion, Huons Biopharma is addressing regional demands and advancing aesthetic and therapeutic treatments worldwide.
FAQs
1. What is Liztox, and who manufactures it?
Liztox product is a botulinum toxin type A formulation manufactured by Huons Biopharma Co., Ltd. This South Korean biotech company is known for its high-quality production standards.
2. What key certifications does Huons Biopharma hold?
Huons Biopharma has obtained Korean Good Manufacturing Practice (KGMP) certification. This assures that its facilities meet the strict hygiene and quality standards set by the Ministry of Food and Drug Safety (MFDS). This ensures that each product has undergone the stringent quality control production.
3. What are the therapeutic applications of Liztox?
While it requires further studies, practitioners use Liztox for both aesthetic procedures and therapeutic treatments. Conditions include post-stroke upper-limb spasticity and reducing benign masseteric hypertrophy.
References
- American Society of Plastic Surgeons. 2024 Plastic Surgery Statistics Report. 2024. https://www.plasticsurgery.org/documents/news/statistics/2024/plastic-surgery-statistics-report-2024.pdf
- Ye DH, Chun MH, Park YG, et al. A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox® versus Botox® in Post-Stroke Upper Limb Spasticity. Toxins. 2023;15(12):697. doi:https://doi.org/10.3390/toxins15120697
