Chong Kun Dang headquarters. [Chong Kun Dang]
Chong Kun Dang headquarters. [Chong Kun Dang]

CKD Bio said Tuesday it had submitted a biologics license application to China's National Medical Products Administration for its self-developed botulinum toxin product CU-20101.

The company aims to accelerate commercialization and officially launch the product in China in the second half of 2027. China is the world's second-largest botulinum toxin market after the United States, and demand is rising sharply alongside the rapid growth of the local medical aesthetics industry.

The application was based on results from a Phase 3 trial conducted with 554 participants. In that trial, CKD Bio demonstrated CU-20101's non-inferiority to Allergan's Botox — the global reference drug — in improving moderate to severe glabellar lines.

The company also secured strong safety results. The adverse reaction profile was comparable to that of the Botox control group, and no serious treatment-related adverse reactions were reported. Repeated administration maintained efficacy and safety equivalent to a single dose, confirming the product's clinical utility for long-term treatment.

CKD Bio said the China filing is significant because it demonstrated efficacy and safety on par with the originator drug in one of the world's largest — and most difficult to enter — aesthetic markets, establishing a foothold for broader expansion into the global botulinum toxin market beyond Greater China.

"Based on the effectiveness and safety confirmed through the Phase 3 trial, we will proceed with approval and launch in China without disruption," a company official said. "We will use our entry into China, the world's second-largest market, as a springboard to build competitiveness and actively pursue the global market."

CKD Bio signed an exclusive license-out agreement with Hong Kong-listed biotech Cutia Therapeutics in 2022 to enter the Greater China market. The company plans to achieve rapid market penetration and expand its share immediately upon approval, leveraging Cutia's aesthetic sales, marketing and retail networks across China.


silverpaper@heraldcorp.com