拨康视云-B(02592)成功向药品审评中心提交CBT-009新药临床试验申请

智通财经
Jan 06

智通财经APP讯,拨康视云-B(02592)发布公告,本公司于美利坚合众国(美国)特拉华州注册成立的全资附属公司 ADS Therapeutics LLC (ADS USA)已成功向中国国家药品监督管理局(国家药监局)的药品审评中心(药审中心)提交本集团核心产品之一CBT-009的新药临床试验申请。

CBT-009是一种由本集团独立开发的新型、非水性阿托品眼用制剂,用于治疗5至19岁儿童及青少年的青少年近视。与现有水性阿托品滴眼液相比,CBT-009显著提升制剂稳定性,可在室温下长期储存且无需添加防腐剂,大幅改善患者用药依从性与使用体验。

本公司认为,成功向药审中心提交新药临床试验申请,标志着CBT-009在中国临床开发的重要里程碑,为集团在该重要市场推进第三期临床试验奠定坚实基础。本集团将持续密切关注药审中心的审评进度,并于适时另行刊发公告,以知会本公司股东及潜在投资者相关最新发展。

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