Glory 11月28日, Keqi-B (02487.HK) announced that the group's Chinese Phase III clinical trial results of CU-40102 (topical finasteride spray for androgenetic alopecia) and CU-30101 (local lidocaine prilocaine cream for skin epidermal surgery) were presented in electronic poster form at the 19th Chinese Physician Association Dermatologist Annual Conference and National Aesthetic Dermatological Science Conference ('CDA Conference'). The group's research achievements have been selected for two consecutive sessions at the CDA Conference, representing the group's industry influence and cutting-edge level in the field of dermatology.
The Phase III registration clinical trial results of CU-40102 (topical finasteride spray) in China
The Phase III registration clinical trial of CU-40102 in China is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of CU-40102 in Chinese adult male androgenetic alopecia patients. The clinical trial included 270 subjects, with the primary efficacy endpoint being the change in total hair count within the target area of vertex balding at 24 weeks compared to baseline. Adverse events and local skin tolerability were also assessed in this clinical trial.
The results of this clinical trial showed that in terms of efficacy, at 24 weeks of treatment, the total hair count and terminal hair count within the target area of vertex balding in the CU-40102 group improved significantly compared to baseline, outperforming the placebo group with statistically significant differences (P<0.05), meeting the primary and major secondary endpoints, with effectiveness demonstrated from week 12 onwards. Additionally, the efficacy rate based on researchers' assessment of vertex hair score showed CU-40102 group significantly better than the placebo group at 24 weeks of treatment, with differences having statistical significance (P<0.05). In terms of safety, local tolerability at the application site of CU-40102 subjects was good, overall incidence of adverse events (AE) was similar between CU-40102 group and placebo group, with no occurrence of severe adverse events (SAE) or treatment-emergent adverse events (TEAE) leading to death.
The new drug application (NDA) of CU-40102 was accepted by the China National Medical Products Administration in January 2024. The group also submitted NDA to the Hong Kong Department of Health in April 2024.
The Phase III registration clinical trial results of CU-30101 (local lidocaine prilocaine cream) in China
The Phase III registration clinical trial of CU-30101 in China is a multicenter, randomized, double-blind, positive drug-controlled, paired design clinical trial to evaluate the safety and efficacy of CU-30101 for local anesthesia in skin epidermal surgery. The clinical trial included 286 subjects, with the reference formulation Pliaglis (lidocaine prilocaine cream) used as a control, and the main efficacy endpoint being immediate postoperative visual analog scale pain score (VAS) following dot matrix laser surgery. Adverse events and local skin tolerability were also evaluated in this clinical trial.
The results of this clinical trial showed that in terms of efficacy, the difference in VAS values between the two sides of the face (CU-30101 side - Pliaglis side) was within the predefined equivalence range, demonstrating comparable analgesic efficacy between CU-30101 and Pliaglis, meeting the primary endpoint. Furthermore, there were no statistically significant differences (P>0.05) in subjects' evaluations of 'whether the two study drugs can adequately relieve pain', 'whether they would use the study drug for local anesthesia again', and 'researchers' satisfaction with the effectiveness of the two study drugs'. In terms of safety, CU-30101 demonstrated good overall safety profile, with no occurrences of severe adverse events or serious adverse events. The local tolerability assessment on the CU-30101 side was similar to that of the Pliaglis side and consistent with the known safety features of Pliaglis, with no new safety signals observed.
The pharmaceutical marketing authorization application for CU-30101 was accepted by the China National Medical Products Administration in July 2024.
