VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG APPLICATION OF CU-10101 (TOPICAL NOVEL SMALL MOLECULE AGENT) FOR ATOPIC DERMATITIS APPROVED BY THE CENTER FOR DRUG EVALUATION OF THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
2024-05-30 · 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 INVESTIGATIONAL NEW DRUG APPLICATION OF CU-10101 (TOPICAL NOVEL SMALL MOLECULE AGENT) FOR ATOPIC DERMATITIS APPROVED BY THE CENTER FOR DRUG EVALUATION OF 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. Reference is made to the voluntary announcement of the Company dated 27 March 2024 in relation to the investigational new drug (the “IND”) application of CU-10101 (topical novel small molecule agent) of the Group, for the treatment of mild to moderate atopic dermatitis has been accepted by the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration of the People ’s Republic of China (the “PRC”). The board of directors (the “Board ”) of the Company is pleased to announce that the IND application of CU-10101 has been approved by the CDE to conduct a Phase I clinical trial in the PRC. CU-10101 is a non-hormonal, small molecule drug for the treatment of mild to moderate atopic dermatitis. For atopic dermatitis, the therapeutic options are limited and mainly include corticosteroids, calcineurin inhibitors, systemic immunosuppressants, and targeted biologics and small-molecule drugs. Localized topical corticosteroids are the most commonly prescribed therapies for atopic dermatitis. Most targeted biologics and small molecule drugs for atopic dermatitis require subcutaneous or oral administration, where systemic exposure causes a higher risk of side effects and lower patient compliance than localized topical application. The non- hormonal properties of CU-10101 may reduce the side effects and restrictions associated with corticosteroids and its localized topical formulation allows the medication to reach the affected areas directly. 2 Warning: There is no assurance that CU-10101 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, 30 May 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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