Chong Kun Dang Bio announced on the 18th that it has submitted a Biologics License Application (BLA) for its independently developed botulinum toxin product “CU-20101” to China’s National Medical Products Administration (NMPA).

Through this marketing authorization application, Chong Kun Dang Bio will proceed with commercialization procedures with the aim of launching the product in China in the second half of 2027. China is assessed as the world’s second-largest botulinum toxin market after the United States.

According to Chong Kun Dang Bio, CU-20101 demonstrated non-inferiority in improving glabellar lines compared with Botox in a Phase 3 clinical trial conducted on a total of 554 subjects in China. The incidence pattern of adverse events was at a similar level to that of Botox, and no serious treatment-related adverse events were reported. The company added that repeated administration produced efficacy and safety results similar to those seen with a single administration.

Previously, in 2022, Chong Kun Dang Bio signed an exclusive Greater China licensing agreement with Cutia Therapeutics, a Hong Kong-listed biotech company, to enter the Chinese and Greater China markets. Cutia plans to leverage its sales and marketing network in China’s aesthetics sector to handle local sales of CU-20101 after approval.

A Chong Kun Dang Bio official stated, “Based on the efficacy and safety confirmed in the Phase 3 clinical trial, the company will pursue approval and launch in China,” adding, “Building on its entry into China, the company also plans to expand its penetration of the global market.”

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