Voluntary Announcement: IND Approval Received for A Phase III Clinical Trial of OT-101 in the United States
The board of directors of the Company (the "Board") is pleased to announce that an investigational new drug ("IND") approval for initiating a multi-regional phase III clinical trial (the "Phase III MRCT") in the United States for OT-101, a self developed product of the Group, has been received from the United States Food and Drug Administration in February 2021. The Company plans to file IND applications with the regulatory authorities in both China and Europe Union in 2021 and initiate the Phase III MRCT of OT-101 in these regions accordingly.
OT-101 is a low-concentration atropine 0.01% eye drop developed by the Group to retard, or slow down, the progression of myopia in children and adolescents. The instability of low-concentration atropine solutions has long been a technical barrier for its commercialization. The Group developed a storage and delivery system to address low-concentration atropine solution's instability, and also conducted several rounds of tests on the system's reliability, closure integrity and sterility conditions.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that it will ultimately commercialize OT-101 successfully. Shareholders of the Company and potential investors are advised to exercise caution when dealing in the shares of the Company.
By order of the Board of
Dr. Lian Yong CHEN
Chairman and Executive Director
As of the date of this announcement, the Board comprises Dr. Lian Yong CHEN, Mr. Ye LIU, Dr. Zhaopeng HU and Dr. Wei LI as executive directors, Mr. Yanling CAO and Mr. Lefei SUN as non-executive directors, and Mr. Ting Yuk Anthony WU, Mr. Lianming HE, and Mr. Yiran HUANG as independent non-executive directors.
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.