OCUMENSION-B (01477): The National Medical Products Administration has approved the application for the marketing registration of the new drug OT-1001.

OCUMENSION-B (01477) announced that the application for the registration of OT-1001 (Ziwotai), a potent and highly selective histamine H-1 receptor antagonist with anti-allergic properties, has recently been approved by the China National Medical Products Administration (NMPA) Drug Evaluation Center. OT-1001 (Ziwotai) is developed by Nicox Ophthalmics, Inc. (Nicox) and has been approved by the U.S. Food and Drug Administration for use in patients aged two and above. The Group obtained exclusive licensing rights from Nicox in March 2019 to develop, manufacture, outsource manufacture, import, export, use, distribute, market, promote, offer for sale, and sell (or otherwise commercialize) OT-1001 (Ziwotai) in the Greater China region, and expanded its exclusive rights to 11 Southeast Asian countries in March 2020. OT-1001 is the first and only eye drops formulation containing the active ingredient hydrochloride cetirizine (active ingredient of ZYRTEC), used in the United States for the treatment of eye itching related to allergic conjunctivitis. We believe that the approval of OT-1001 (Ziwotai) can address unmet medical needs or potentially provide significant improvements to existing treatment options, benefiting patients in China with similar symptoms.