康哲药业 (00867.HK):用于治疗乾眼症的 0.09% 环孢素滴眼液获临床试验通知书

格隆汇 · 2020-06-30

格隆汇 6 月 30 日丨康哲药业 (00867.HK) 公布,有关于与SunPharmaceutical Industries Ltd.就用于治疗乾眼症的 0.09% 环孢菌素 A 滴眼液 (现获得中国国家药品监督管理局签发的临床试验通知书中的名称为"0.09% 环孢素滴眼液") 签订许可协议。产品是一种溶于透明、无防腐剂的水溶液中的纳米技术制剂,已被美国食品药品监督管理局批准以 CEQUATM 的商品名称在美国商业化。

产品于2020年6月30日获得中国国家药品监督管理局签发的临床试验通知书,同意开展增加乾燥性角膜结膜炎患者泪液分泌的临床试验,即 0.09% 环孢素滴眼液治疗乾燥性角膜结膜炎的安全性和有效性的随机、双盲、安慰剂对照、多中心临床研究。集团正积极准备开展产品的临床试验。

Long Bridge Securities Ltd is a New Zealand registered Financial Service Provider (FSP number: FSP600050), and is a member of the Financial Dispute Resolution Scheme, a New Zealand independent dispute resolution service provider.

All data and contents of the Long Bridge website (longbridge.global) are for investors' reference only. Before conducting investment activities, investors should fully understand the relevant products, clearly know their potential risks, and make rational decisions based on their own risk tolerance; and investors should be aware that all investment activities involve risks and investment activities may not be suitable for every investor.

Customer Service Hotline:400-071-2688

0800 33 9033 / (09) 533 9033(New Zealand)

Support Email: service@longbridge.global
简体中文