[Market Focus] Chong Kun Dang Bio Soars Over 20% on News of Botulinum Toxin Efficacy Demonstration

Efficacy in Improving Glabellar Lines

On the morning of January 20, Chong Kun Dang Bio saw its stock surge by more than 20% in early trading. The buying momentum appears to have been driven by news that the efficacy of its botulinum toxin was demonstrated in a Phase 3 clinical trial in China.

As of 10:17 a.m. on the same day, shares of Chong Kun Dang Bio were trading at 24,400 won on the Korea Exchange, up 27.35% from the previous trading day. The stock opened at 19,200 won and continued to climb, reaching as high as 24,650 won during intraday trading.

The previous day, Chong Kun Dang Bio announced that its botulinum toxin product 'CKDB-501A' (project name in China: CU-20101) had demonstrated non-inferiority compared to 'Botox' in a Phase 3 clinical trial in China. According to the company, it received topline (primary endpoint) data from the Chinese Phase 3 clinical trial evaluating the efficacy and safety of CU-20101 for the improvement of moderate or severe glabellar lines. The trial involved randomizing adults aged 18 to 65 with moderate or severe glabellar lines into either the test group (CU-20101, n=278) or the control group (Botox, n=275) in a 1:1 ratio, administering a single dose, and then evaluating efficacy and safety at 4-week intervals over a 12-week period.

The primary endpoint for efficacy assessment was the proportion of subjects whose investigator-assessed Frown Wrinkle Score (FWS) was 0 or 1 at week 4 after a single dose, and whose score had decreased by at least 2 points from baseline (improvement rate of glabellar lines).

The results showed that this proportion was 74.0% in the CU-20101 group and 74.9% in the Botox group, demonstrating non-inferiority. The incidence of adverse events after a single dose was 52.9% in the CU-20101 group and 50.9% in the Botox group. Among these, the rate of drug-related adverse reactions that could not be ruled out was 2.5% in the test group and 2.9% in the control group. The incidence of serious adverse events was 1.1% in the test group and 2.2% in the control group, with no serious drug-related adverse reactions that could not be ruled out in either group.

Chong Kun Dang Bio stated, "This clinical trial demonstrated that CKDB-501A is effective in improving moderate or severe glabellar lines," adding, "We plan to prepare a clinical study report and apply for product approval in China."