VOLUNTARY ANNOUNCEMENT - DRUG MARKETING AUTHORIZATION APPLICATION FOR CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
2024-07-30 · 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 DRUG MARKETING AUTHORIZATION APPLICATION FOR CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) ACCEPTED 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. Reference is made to the voluntary announcement of the Company dated 31 January 2024 in relation to the Phase III clinical trial of CU-30101 (localized topical lidocaine and tetracaine cream) of the Group conducted in the People ’s Republic of China (the “PRC”) reaching primary endpoint. The board of directors (the “Board”) of the Company is pleased to announce that drug marketing authorization application for CU-30101 of the Group was accepted by the National Medical Products Administration (the “NMPA”) of the PRC. CU-30101 is a localized lidocaine and tetracaine compound topical anesthesia cream for surface dermatologic operations. The formulation of lidocaine and tetracaine combination in CU- 30101 may produce rapid and long-lasting anesthetic effects due to its ingredients ’ unique pharmacokinetic properties. Lidocaine diffuses more rapidly, and more extensively than tetracaine, whereas tetracaine, a long-acting localized anesthetic amino acid ester, is more lipophilic than lidocaine and can be concentrated in the topical stratum corneum. Systemic absorption of the anesthetic component ingredients is also limited from the topical cream formulation. 2 Warning: There is no assurance that CU-30101 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, 31 July 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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