On Tuesday, industry sources reported that Chong Kun Dang Pharmaceutical Corp. announced on Monday that its botulinum toxin product, CKDB-501A (known as CU-20101 in China), demonstrated non-inferiority to Botox in Phase 3 clinical trials conducted in China.
The company received topline data, a crucial indicator of CKDB-501A’s efficacy and safety in improving moderate-to-severe glabellar lines.
The Phase 3 trial in China evaluated CKDB-501A’s efficacy, safety, and immunogenicity following a single dose, benchmarking it against Botox. Researchers also analyzed these factors with repeated doses.
The study involved 553 adults aged 18 to 65 with moderate-to-severe glabellar lines. Participants were divided into two groups: 278 received CKDB-501A, while 275 received Botox. Following a single administration, researchers assessed efficacy and safety at 4-week intervals over 12 weeks.
The primary efficacy endpoint was the proportion of subjects with a glabellar line score (FWS) of 0 or 1 at 4 weeks after a single dose, demonstrating a reduction of at least 2 points from baseline.
Results showed this rate was 74.0% in the CKDB-501A group and 74.9% in the Botox group, confirming CKDB-501A’s non-inferiority to Botox.
Adverse event rates after a single dose were 52.9% for CKDB-501A and 50.9% for Botox. Potentially drug-related adverse reactions were 2.5% in the test group and 2.9% in the control group. Serious adverse events occurred in 1.1% of the CKDB-501A group and 2.2% of the Botox group, with no serious drug-related adverse reactions identified.
A representative of Chong Kun Dang Pharmaceutical Corp. said the clinical trial demonstrated CKDB-501A’s effectiveness in improving moderate-to-severe glabellar lines and noted that the company is preparing a clinical report to apply for product approval in China.
The company also highlighted that CKDB-501A uses non-animal-derived materials and additives, which minimize the risk of blood-borne pathogens. Based on the Phase 3 results, it expects potential market share gains and export growth in China’s botulinum toxin market for glabellar line treatment, outcomes it said could generate significant economic benefits.