Chong Kun Dang Bio applies for Chinese approval of botulinum toxin; aims for second-half 2027 launch

Chong Kun Dang Bio (CKD Bio) has taken a significant step towards entering the Chinese market by submitting a Biologics License Application (BLA) for its self-developed botulinum toxin product, CU-20101, to China's National Medical Products Administration (NMPA).

The company is targeting a commercial launch in China in the second half of 2027. This move positions CKD Bio to compete in China's botulinum toxin market, which is considered the second largest globally, trailing only the United States.

According to CKD Bio, Phase 3 clinical trials conducted in China involving 554 participants showed that CU-20101 achieved non-inferiority to Botox in improving glabellar lines. The incidence of adverse events was comparable to Botox, with no serious treatment-related adverse events reported. The product also demonstrated consistent efficacy and safety in repeat administrations.

To facilitate its entry into the Chinese and broader Greater China markets, CKD Bio previously signed an exclusive licensing agreement in 2022 with Cuthia Therapeutics, a Hong Kong-listed biotech firm. Cuthia will leverage its established sales and marketing network in the Chinese aesthetics sector to handle the local sales of CU-20101 post-approval.

A CKD Bio representative stated, "Based on the efficacy and safety confirmed through Phase 3 clinical trials, we will proceed with the approval and launch in China. We also plan to expand our global market offensive based on our entry into China."

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Based on the efficacy and safety confirmed through Phase 3 clinical trials, we will proceed with the approval and launch in China. We also plan to expand our global market offensive based on our entry into China.