VOLUNTARY ANNOUNCEMENT - ABBREVIATED NEW DRUG APPLICATION FOR CU-40105 (SELF-DEVELOPED TOPICAL FINASTERIDE SPRAY) ACCEPTED BY THE NMPA
2025-11-18 · 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 ABBREVIATED NEW DRUG APPLICATION FOR CU-40105 (SELF-DEVELOPED TOPICAL FINASTERIDE SPRAY) ACCEPTED BY THE NMPA 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 Abbreviated New Drug Application (ANDA) for the Group ’s CU-40105 (self-developed topical finasteride spray) has been accepted by the National Medical Products Administration (the “NMPA”) of the People ’s Republic of China. The indication is for the treatment of androgenetic alopecia. 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, topical finasteride allows patients to apply the drug directly to the surface of the scalp, thereby reducing the systemic exposure of the drug compared with oral formulations. The Group believes that topical finasteride will be more acceptable to patients with androgenetic alopecia, offering a new alternative drug option in their treatment. CU-40105 will further expand the Group ’s scalp diseases product matrix. The formulation, dosage form, strength, indication, route of administration, and usage of CU-40105 are consistent with the reference listed drug. Furthermore, key excipients for CU-40105 are exclusively supplied by the original manufacturer to ensure that the product ’s quality and performance are consistent with the reference formulation. In response to the extensive treatment needs in the androgenetic alopecia market, the Group expects CU-40105 to facilitate a differentiated commercialization strategy targeting diverse consumers and patients, thus further expanding the coverage of topical finasteride among target population. 2 Warning: There is no assurance that CU-40105 will ultimately be successfully developed and 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, 19 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.
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