CKD BiO has begun the process to enter the Chinese market with its independently developed botulinum toxin.
CKD BiO(063160) said on the 18th that it submitted a biologics license application (BLA) for the botulinum toxin formulation "CU-20101" to the National Medical Products Administration (NMPA) of China. The company is aiming to launch in China in the second half of next year.
CU-20101 conducted a phase 3 clinical trial in China with a total of 554 participants. The trial compared the improvement of glabellar lines with Botox and demonstrated noninferiority, showing that CU-20101 is not inferior to Botox.
Safety was similar between the two products. No treatment-related serious adverse events were reported, and repeat dosing showed efficacy and safety results comparable to single dosing.
China is considered the world's second-largest botulinum toxin market after the United States. As demand for medical aesthetics grows, the market is expanding, and domestic companies have been pursuing entry.
CKD BiO signed an exclusive license agreement in 2022 with the Hong Kong–listed biotech company Cutia Therapeutics to enter the Chinese and Greater China markets. Cutia has sales and marketing networks in the aesthetics field across China and is slated to handle local sales of CU-20101 after approval.