VOLUNTARY ANNOUNCEMENT - RESULTS OF PHASE III CLINICAL TRIAL OF CU-40102 (TOPICAL FINASTERIDE SPRAY) IN THE PRC ACCEPTED FOR E-POSTER PRESENTATION AT THE 8TH ANNUAL MEETING OF CHINESE HAIR RESEARCH SOCIETY
2024-08-29 · Cutia Therapeutics(Wuxi)Co.,Ltd · original cutiatx.com ↗
1 Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. Cutia Therapeutics 科笛集團 (Incorporated in the Cayman Islands with limited liability) (Stock Code: 2487) VOLUNTARY ANNOUNCEMENT RESULTS OF PHASE III CLINICAL TRIAL OF CU-40102 (TOPICAL FINASTERIDE SPRAY) IN THE PRC ACCEPTED FOR E-POSTER PRESENTATION AT THE 8TH ANNUAL MEETING OF CHINESE HAIR RESEARCH SOCIETY This announcement is made by Cutia Therapeutics (the “Company ”, together with its subsidiaries, the “Group ”) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business advancement of the Group. The board of directors (the “Board”) of the Company is pleased to announce that results of the Phase III clinical trial of the Group ’s CU-40102 (topical finasteride spray) for the treatment of androgenetic alopecia in the People ’s Republic of China (the “PRC”) were accepted for e-poster presentation at the 8th Annual Meeting of Chinese Hair Research Society. CU-40102 is the first and only topical finasteride product approved for androgenetic alopecia treatment globally and the first topical finasteride to have its NDA accepted by the National Medical Products Administration (the “NMPA”) of the PRC. The registrational Phase III clinical trial of CU-40102 in the PRC was a multi-center, randomized, double-blind, and placebo-controlled trial to evaluate the efficacy and safety of CU-40102 in Chinese male adult patients with androgenetic alopecia. Results of the clinical trial showed that, in terms of efficacy, improvement of the total hair count and terminal hair count in the targeted bald area of the CU-40102 group was significantly better than that of the placebo group after 24 weeks of treatment. The difference was statistically significant ( P <0.05), reached primary endpoint and key secondary endpoint, and efficacy began to show from week 12. Additionally, based on the investigator assessment score of the targeted bald area, efficacy shown in the CU-40102 group was significantly better than that shown in the placebo group after 24 weeks of treatment, and the difference was statistically significant ( P <0.05). 2 In terms of safety, enrolled patients of the CU-40102 group showed favourable local tolerance to the administration area, and the overall incidence of adverse events in the CU-40102 group was similar to that of the placebo group. There were no treatment-emergent serious adverse events (TESAEs), or treatment-emergent adverse events (TEAEs) leading to death. The NDA for CU-40102 was accepted by the NMPA. For more information, please refer to the voluntary announcement of the Company dated 31 January 2024. Warning: There is no assurance that CU-40102 will ultimately be successfully marketed by the Company. Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company. By order of the Board Cutia Therapeutics Zhang Lele Chief Executive Officer and Executive Director Hong Kong, 29 August 2024 As at the date of this announcement, the Board comprises (i) Ms. Zhang Lele and Mr. Huang Yuqing as executive directors; (ii) Dr. Chen Lian Yong, Dr. Xie Qin, Dr. Huang Xiao and Ms. Yang Yunxia as non-executive directors; and (iii) Mr. Chung Ming Kit, Mr. Tao Tak Yan Dennis and Mr. Ye Xiaoxiang as independent non-executive directors.
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