Jongkundang Bio has applied for regulatory approval in China for its self-developed botulinum toxin product, 'CU-20101.'
The company announced on August 18 that it submitted a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China.
Jongkundang Bio plans to accelerate the commercialization process in the Chinese market, aiming for a launch in the second half of 2027. As the second-largest botulinum toxin market in the world after the United States, China is expected to see continued market expansion due to growth in the medical aesthetics industry.
The company stated that in a Phase 3 clinical trial conducted in China with 554 participants, CU-20101 demonstrated non-inferiority in improving glabellar lines compared to the global leading botulinum toxin product, Botox®.
Safety was also confirmed, with adverse reactions occurring at levels similar to those of Botox, and no serious treatment-related adverse events were reported. The product maintained a similar efficacy and safety profile with repeated dosing, confirming its potential for long-term treatment.
A Jongkundang Bio representative said, "Based on the efficacy and safety confirmed in the Phase 3 trial, we will successfully pursue approval and launch in China. We aim to strengthen our global competitiveness by entering the second-largest botulinum toxin market in the world."
Global market research firm Grand View Research projects that the market size for botulinum toxin (Type A) in China will grow from approximately $1.3 billion (about 1.83 trillion won) in 2024 to $3.6 billion (about 5.08 trillion won) by 2030.
Meanwhile, Jongkundang Bio signed an exclusive licensing agreement with Hong Kong-listed biotech company Quthea Therapeutics in 2022 to enter the Chinese and Greater China markets. The company plans to leverage Quthea's sales and marketing network in the aesthetics sector to expedite the market entry of CU-20101 following regulatory approval.
* This article has been translated by AI.
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