Jongkundang Bio Applies for Product Approval of Botulinum Toxin 'CU-20101' in China
Non-Inferiority to Botox in Improving Glabellar Lines Demonstrated in China Phase 3 Trial
Aiming for Second Half of 2027 Launch... Targeting the Market with Greater China Partner
Jongkundang Bio announced on the 18th that it has submitted a Biologics License Application (BLA) for its independently developed botulinum toxin formulation, CU-20101, to China’s National Medical Products Administration (NMPA). The company is aiming for a commercial launch in China in the second half of 2027.
In Phase 3 clinical trials conducted in China with a total of 554 participants, CU-20101 was shown to be non-inferior to Botox, the leading botulinum toxin product, in the improvement of glabellar lines. The pattern of adverse events was also similar to that of Botox, and no treatment-related serious adverse events were reported. The company also confirmed that repeated administration demonstrated a similar efficacy and safety profile to single administration.
In 2022, Jongkundang Bio signed an exclusive license agreement for the Greater China region with Hong Kong-based biotech company Qutia Therapeutics. Based on its extensive sales and marketing network in the Chinese aesthetic sector, Qutia plans to support the market entry and commercialization of CU-20101 after approval.
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A Jongkundang Bio representative said, “We will work to successfully obtain approval and launch in China based on the efficacy and safety confirmed in the phase 3 clinical trials.”
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