VOLUNTARY ANNOUNCEMENT - SUBMISSION OF NEW DRUG APPLICATION FOR CU-40102 (TOPICAL FINASTERIDE SPRAY) IN HONG KONG, PRC
2024-04-29 · 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 SUBMISSION OF NEW DRUG APPLICATION FOR CU-40102 (TOPICAL FINASTERIDE SPRAY) IN HONG KONG, PRC 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 the New Drug Application (the “NDA”) for CU-40102 (topical finasteride spray) of the Group was submitted to the Department of Health of the Government of the Hong Kong Special Administrative Region (“Hong Kong ”) of the People ’s Republic of China (the “PRC”). The 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 the first topical finasteride to have its NDA accepted by the National Medical Products Administration (the “NMPA ”) of the PRC. The NDA for CU-40102 was accepted by the NMPA in January 2024. Finasteride can treat androgenetic alopecia in male patients 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 while possibly reducing the side effects commonly associated with oral formulations. 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, 30 April 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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