VOLUNTARY ANNOUNCEMENT - CU-40102 (TOPICAL FINASTERIDE SPRAY) OBTAINED MARKETING APPROVAL BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
2025-06-30 · 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 NATIONAL MEDICAL PRODUCTS ADMINISTRATION 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 National Medical Products Administration (the “NMPA ”) of the People ’s Republic of China (the “PRC ” or “China ”). The approved indication of CU-40102 is for the treatment of androgenetic alopecia. CU-40102 is the first and only topical finasteride product approved for androgenetic alopecia treatment globally, and also the first and only topical finasteride approved for marketing in China. 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. The marketing approval of CU-40102 is based on the results of a Phase III pivotal clinical trial (the “Clinical Trial ”) completed in China. Results of the Clinical Trial demonstrated that CU-40102 is effective in treating androgenetic alopecia and showed favourable local tolerance to the administration area. 2 As the Group ’s first scalp diseases and care product approved by the NMPA and the Group ’s second product approved following CU-10201 (4% topical minocycline foam), CU-40102 will strengthen the Group ’s commercial footprint in the broader dermatology treatment and care sector. In addition, a New Drug Application for CU-40102 was submitted to the Department of Health of the Government of the Hong Kong Special Administrative Region of the PRC in April 2024. For more information, please refer to the voluntary announcement of the Company dated 30 April 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, 30 June 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.
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