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香港 - Media OutReach - 2021年2月22日- 本公告乃由欧康维视生物(「本公司」,连同其附属公司,统称为「本集团」)自愿作出,以知会本公司股东及有意投资者有关本集团的最新业务发展。

本公司董事会(「董事会」)欣然宣布,一项新药临床申请(「IND」)已于2021年2月获美国食品药品监督管理局批准,以在美国启动本集团的自主研发产品OT-101的多中心III期临床试验(「III期MRCT」)。本公司计划于2021年向中国及欧盟的监 管机构提交IND申请,从而于该等地区启动OT-101的III期MRCT。

OT-101是本集团开发的一种低浓度阿托品0.01%滴眼液,用于延缓或减慢儿童和 青少年近视的进度。低浓度阿托品溶液并不稳定,故一直存在商业化的技术障 碍。本集团开发了一种存储及交付系统,以解决低浓度阿托品溶液的不稳定性, 并亦已对系统可靠性、密封完整性及无菌条件进行了多轮测试。

香港联合交易所有限公司证券上市规则第18A.05条规定的警示声明:本公司无法 保证其将最终成功商业化OT-101。本公司股东及有意投资者在买卖本公司股份时 务请审慎行事。

承董事会命

欧康维视生物

主席兼执行董事

陈连勇博士

 

截至本公告日期,董事会包括执行董事陈连勇博士、刘晔先生、胡兆鹏博士及李伟博士,非执行董事曹彦凌先生及孙乐非先生,及独立非执行董事胡定旭先生、何连明先生及黄翼然先生。

 

香港交易及结算所有限公司及香港联合交易所有限公司对本公告的内容概不负责,对其准确性或完整性亦不发表任何声明,并明确表示,概不就因本公告全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失承担任何责任。

Source https://www.media-outreach.com/release.php/View/65871#Contact