[Edaily Reporter KIM SAE-MI ] CKDBioCorporation has begun the process of seeking marketing authorization in China for its botulinum toxin product, “Timebus Injection.”

CKDBioCorporation(063160)The company announced on the 14th that it has submitted an application to the China National Medical Products Administration (NMPA) for marketing authorization of Timebus Injection, with the indication for improving moderate to severe glabellar lines.

Previously, from June 2024 through November of last year, CKDBioCorporation evaluated the efficacy and safety of “CU-20101,” the candidate compound for Timebus, in patients aged 18 to 65 with moderate to severe glabellar lines.

According to the clinical results, the improvement rate for glabellar wrinkles in the CU-20101 treatment group was 74.0% (205 out of 277 patients), while that in the Botox treatment group was 74.9% (206 out of 275 patients). The difference between the two groups was -1.5%, and the p-value was 0.7637. The lower limit of the two-sided 95% confidence interval (CI) for the difference between the two groups was -8.6%, which exceeded the pre-specified non-inferiority margin of -12%. Accordingly, CKDBioCorporation explained that CU-20101 demonstrated non-inferiority compared to Botox.

No significant differences were observed between the two groups in terms of safety either. The overall incidence of adverse events following a single dose was 52.9% in the CU-20101 group and 50.9% in the Botox group. Adverse events for which a causal relationship with the drug could not be ruled out were recorded at 2.5% and 2.9%, respectively. The incidence of serious adverse events was 1.1% in the CU-20101 group and 2.2% in the Botox group; no serious drug-related adverse events for which a causal relationship with the drug could not be ruled out occurred in either group.

CKDBioCorporation also conducted a 36-week repeat-dose clinical trial in which eligible patients who had completed the initial trial received up to three additional doses of CU-20101 at 12-week intervals. No serious adverse drug reactions were observed during the repeat-dose phase either.

An official from CKDBioCorporation stated, “We plan to launch the product in the Chinese market after obtaining NMPA marketing authorization.”