Courtesy of Chong Kun Dang Pharmaceutical Corp.

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.

On Tuesday, industry sources reported that Chong Kun Dang Pharmaceutical Corp. announced o …

Botox Faces New Challenger: Chong Kun Dang’s Toxin Shows Non-Inferiority in China Study