drugset / Press release

VOLUNTARY ANNOUNCEMENT - CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE HONG KONG DEPARTMENT OF HEALTH

2025-08-01 · 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 CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE HONG KONG DEPARTMENT OF HEALTH 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 CU-40102 (topical finasteride spray) of the Group has obtained marketing approval by the Department of Health of the Government of the Hong Kong Special Administrative Region ( “Hong Kong ”) of the People ’s Republic of China ( “China”) (the “Hong Kong Department of Health ”). The approved indication is for the treatment of androgenetic alopecia. This is another significant milestone for CU-40102 following the marketing approval obtained by the National Medical Products Administration of China (the “NMPA”). Finasteride can treat androgenetic alopecia by acting as a competitive and specific inhibitor of Type II 5-alpha reductase to inhibit the conversion of testosterone to dihydrotestosterone in the scalp. Unlike oral finasteride, CU-40102 ’s topical formulation allows patients to apply the drug directly to the surface of the scalp, thereby maintaining a high concentration at the affected site and reducing the systemic exposure of the drug compared with oral formulations. The Group believes that CU-40102, as a topical treatment, will be more acceptable to patients with androgenetic alopecia, offering a new alternative in their treatment options. As an important approved scalp diseases and care product of the Group, CU-40102 is now in nationwide commercialization preparation in China. This approval will accelerate CU-40102 ’s global expansion, broaden its market reach, and benefit more patients with androgenetic alopecia. For more information regarding the CU-40102 ’s marketing approval by the NMPA, please refer to the voluntary announcement of the Company dated 30 June 2025. 2 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, 1 August 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. Tao Tak Yan Dennis and Mr. Ye Xiaoxiang as independent non-executive directors.

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