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    1477   KYG674111011

OCUMENSION THERAPEUTICS

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Ocumension Therapeutics : VOLUNTARY ANNOUNCEMENT NEW DRUG APPLICATION FOR OT-401 ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

04/07/2021 | 10:34am EDT

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.

Ocumension Therapeutics

歐康維視生物

(Incorporated in the Cayman Islands with limited liability)

(Stock code: 1477)

VOLUNTARY ANNOUNCEMENT

NEW DRUG APPLICATION FOR OT-401 ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

This announcement is made by Ocumension Therapeutics (the "Company", together with its subsidiaries, the "Group") on a voluntary basis to keep the shareholders of the Company and potential investors informed of the latest business updates of the Group.

The board (the "Board") of directors of the Company is pleased to announce that the new drug application for OT-401 (YUTIQ), one of the Company's key drug candidates, has been accepted by the National Medical Products Administration of the People's Republic of China ("NMPA") on April 7, 2021. OT-401 (YUTIQ) is the first ophthalmic drug of the Company whose new drug application has been accepted by NMPA, and is also the first sustained-releasemicro-insert submitted for new drug application in mainland China that has a controlled release rate for up to 36 months. It is the first time that NMPA has accepted the new drug application based on real world study data.

OT-401 (YUTIQ) is a first-in-class, innovative injectable, sustained-releasemicro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye in-licensed from EyePoint Pharmaceuticals, Inc., a company whose shares of common stock are listed on the Nasdaq Stock Market under ticker symbol "EYPT". OT-401 is a sterile non-bioerodible intravitreal implant designed to provide sustained release of a total of 0.18mg of the active ingredient fluocinolone acetonide, a corticosteroid, at a controlled rate for up to 36 months from a single administration performed in an outpatient visit. To date, YUTIQ is the first and only uveitis treatment designed to deliver fluocinolone for up to 36 months that has been approved by the United States Food and Drug Administration.

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-401(YUTIQ) 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

Ocumension Therapeutics

Dr. Lian Yong CHEN

Chairman and Executive Director

Hong Kong, April 7, 2021

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 Ms. Yumeng WANG as non-executive directors, and Mr. Ting Yuk Anthony WU, Mr. Lianming HE, and Mr. Yiran HUANG as independent non-executive directors.

Disclaimer

Ocumension Therapeutics published this content on 07 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 April 2021 14:33:01 UTC.


© Publicnow 2021
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