drugset / Press release

VOLUNTARY ANNOUNCEMENT - RESULTS OF PHASE III CLINICAL TRIAL OF CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) IN CHINA ACCEPTED FOR E-POSTER PRESENTATION AT THE 30TH ANNUAL MEETING OF CSD

2025-06-26 · 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 RESULTS OF PHASE III CLINICAL TRIAL OF CU-30101 (LOCALIZED TOPICAL LIDOCAINE AND TETRACAINE CREAM) IN CHINA ACCEPTED FOR E-POSTER PRESENTATION AT THE 30TH ANNUAL MEETING OF CSD 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 results of the Phase III clinical trial (the “Phase III Clinical Trial ”) in China of the Group ’s CU-30101 (localized topical lidocaine and tetracaine cream) for topical anesthesia operations were accepted for e-poster presentation at the 30th Annual Meeting of Chinese Society of Dermatology (the “Annual Meeting of CSD ”). The Group ’s research results have been selected for the Annual Meeting of CSD for two consecutive years, representing the Group ’s influence in the industry and its advanced standing in the field of dermatology. The Phase III Clinical Trial was a multi-center, randomized, double-blind, positive drug control and pairing designed trial to evaluate the safety and efficacy of CU-30101 for localized analgesia in topical anesthesia operations. Pliaglis ® lidocaine and tetracaine cream ( “Pliaglis ®”) served as the control drug and the reference product for the Phase III Clinical Trial, with the primary efficacy endpoint being Visual Analog Scale ( “VAS”) for immediate pain assessment after fractional laser surgery. Adverse events and local skin tolerability were also being assessed as well. 2 Results of the clinical trial showed that, in terms of efficacy, VAS differences (CU-30101 side-Pliaglis ® side) on both sides of the face were within the preset equivalence interval, and CU-30101 was as effective as Pliaglis ® in analgesia and achieved the primary endpoint. In addition, no statistical differences were observed ( P >0.05) in the differences in the evaluation of “whether the two studied drugs provide the enrolled subjects with adequate pain relief ”, “whether the studied drugs will be used again for localized dermatologic anesthesia ” and “investigator satisfaction on the effectiveness of the two studied drugs ”. In terms of safety, the clinical trial demonstrated an overall favorable safety profile for CU-30101, with no severe adverse events or serious adverse events. The local tolerance assessment of CU-30101 was similar to that of Pliaglis ®, and was consistent with the known safety profile of Pliaglis ®, with no new safety signals observed. Based on the Phase III Clinical Trial, the Group has submitted the drug marketing authorization application for CU-30101, which was accepted by the National Medical Products Administration in July 2024. For more information, please refer to the voluntary announcement of the Company dated 31 July 2024. 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, 27 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.

The release as fetched from its publisher. cutiatx.com ↗