(Health Korea News / Soon-ho Lee) Huons Group’s botulinum toxin business is expected to get back on track soon. Currently, the development of new formulations and new indications has reached the final stage, and commercialization in China is expected to be possible as early as next year. Construction of a new factory for global expansion is scheduled to be completed this year, so it is expected that related businesses will experience explosive growth in the next one to two years.
According to the Ministry of Food and Drug Safety on the 25th, Huons Biopharma, which is in charge of Huons Group’s botulinum toxin business, recently ended recruiting subjects for domestic phase 3 clinical trials of the next-generation botulinum toxin preparation ‘HU-045’. The final test subject selection was made about four months after the first test subject recruitment last June, and the test is scheduled to be completed after an evaluation period of about half a year.
‘HU-045’ is a new botulinum toxin preparation that Huons Biopharma is developing to reduce the possibility of developing resistance. By removing non-toxin proteins and purifying neurotoxins with a size of 150 kDa, the possibility of forming neutralizing antibodies was lowered.
In this clinical trial, Huons Biopharma aims to prove efficacy and safety by comparatively evaluating ‘HU-045’ and ‘Xeomin’ from Merz, Germany.
Huons Biopharma has also entered the final stage of phase 3 clinical trials related to the indication for improving square jaw for ‘Liztox (export name: Hutox)’, a freeze-dried self-developed botulinum toxin preparation. The final subject selection was already completed at the end of last year, and considering that the drug administration period is 12 months, it is expected to be completed as early as this year.
Daewoong Pharmaceutical’s ‘Nabota’ is the only botulinum toxin preparation approved for square jaw improvement in Korea. Excluding ‘Nabota’, Huons Biopharma’s ‘Liztox’ is the closest to commercialization for indications for improving square jaw.
The square jaw is the most preferred treatment area for patients receiving botulinum toxin treatment. As more than half of patients are receiving square jaw procedures on a regular basis, it is predicted that if ‘Liztox’ secures the corresponding indication, there will be fierce competition for market share with ‘Nabota’.
‘Hutox’ begins approval process in China… Flexibility in global expansion
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Huons Biopharma is also speeding up its entry into the global botulinum toxin preparation market. In particular, expectations are high for local commercialization as the approval process for ‘Hutox’ is in progress in China, which is considered one of the world’s three largest botulinum toxin product markets along with the United States and Europe.
The Center for Drug Evaluation (CDE) under China’s National Food and Drug Administration (NMPA) received the application for product approval for ‘Hutox’ submitted by IMEIK TECHNOLOGY and Huons Biopharma last June and began full-scale review.
Eye Maker plans to successfully complete the approval process for ‘Hutox’ and increase synergy with existing medical device products such as fillers. In addition, the company plans to respond to diversifying market demand and strengthen brand influence and core competitiveness through a more complete supply of medical beauty products.
Eye Maker, a partner of Huons Biopharma, is a rapidly growing Chinese aesthetic company. It has established cooperative relationships with over 7,000 plastic surgery and dermatology hospitals across China, and has a number of medical beauty products, including fillers. Based on these strengths, it recorded sales of 2.869 billion yuan, or about 544.8 billion won in Korean currency, last year. The sales increase rate compared to the previous year reached 47.99%.
This gives weight to the observation that the approval process for ‘Hutox’ is highly likely to proceed smoothly due to its significant local influence.
Huons Biopharma has obtained product approval for ‘Hutox’ or is currently undergoing the approval process in many countries in the Middle East, Central and South America, and Southeast Asia, as well as in China. In the US and Europe, we have completed our search for partners and are preparing to enter the local market.
In line with this, the company also began expanding its production facilities. In July of last year, the company began construction of its third bio plant by investing about 70 billion won in Jecheon Bio Valley in North Chungcheong Province, with the goal of completion this year.
Bio Factory 3 will be built with a total floor area of 10,744 m2 and five floors above ground. After completing the 3rd factory, Huons Biopharma plans to equip facilities and increase production capacity to begin the overseas expansion of ‘Riztox’, a botulinum toxin preparation.
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Source: www.hkn24.com
