drugset / Press release

VOLUNTARY ANNOUNCEMENT - POST-HOC ANALYSIS OF PHASE III CLINICAL TRIAL OF CU-10201 (TOPICAL 4% MINOCYCLINE FOAM) IN THE PRC ACCEPTED FOR ORAL PRESENTATION AT THE 20TH CDA ANNUAL MEETING

2025-11-10 · 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 POST-HOC ANALYSIS OF PHASE III CLINICAL TRIAL OF CU-10201 (TOPICAL 4% MINOCYCLINE FOAM) IN THE PRC ACCEPTED FOR ORAL PRESENTATION AT THE 20TH CDA ANNUAL MEETING 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 a post-hoc analysis of the Phase III clinical trial of the Group ’s CU-10201 (topical 4% minocycline foam) for the early efficacy of the treatment of moderate to severe facial acne vulgaris in the People ’s Republic of China (the “PRC”) was accepted for oral presentation at the 20th Annual Meeting of China Dermatologist Association & National Congress of Cosmetic Dermatology (the “20th CDA Annual Meeting ”). CU-10201 is the first and only topical minocycline approved for acne vulgaris treatment globally and the first topical minocycline with priority review designation to obtain marketing approval by the National Medical Products Administration of the PRC. CU-10201 ’s 12-week efficacy and safety in Chinese patients with moderate to severe acne vulgaris have been demonstrated in a Phase III clinical trial. This post-hoc analysis was aimed to evaluate early efficacy of CU-10201 in Chinese patients with moderate to severe facial acne vulgaris during the first and second week of treatment. Efficacy analysis showed that CU-10201 demonstrated a significant rapid onset of action in Chinese patients with moderate to severe facial acne vulgaris. Significant improvement in inflammatory lesions was observed during the first week of treatment, with further improvement observed in the second week. These early efficacy data suggested that CU-10201 may offer a clinically significant treatment option for rapidly relieving symptoms in patients with acne vulgaris. 2 Warning: There is no assurance that CU-10201 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, 10 November 2025 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. Zhang Zhisong and Mr. Ye Xiaoxiang as independent non-executive directors.

The release as fetched from its publisher. cutiatx.com ↗