兆科眼科-B(06622)研发生产的抗青光眼药物贝美素噻吗洛尔滴眼液获批上市
Zhitongcaijing · 02/20/2023 10:17
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智通财经APP讯，兆科眼科-B(06622)公布，由该公司研发生产的抗青光眼药物贝美素噻吗洛尔滴眼液(晶贝莹®)获得国家药品监督管理局(NMPA)批准上市，用于降低对β-受体阻滞剂或前列腺素类似物治疗效果不佳的原发性开角型青光眼及高眼压症患者的眼压。
据悉，贝美素噻吗洛尔滴眼液(晶贝莹®)是中国首个用于治疗青光眼╱高眼压症的贝美素噻吗洛尔滴眼液仿製药。该产品生产线符合GMP符合性检查，已通过一致性评价。
贝美素噻吗洛尔滴眼液为复方制剂，其组份为贝美前列素和马来酸噻吗洛尔，通过增加房水经葡萄膜巩膜及小梁网途径的外流和减少睫状体房水的生成的三重途径降低眼内压，与其它复方制剂相比，具有强效降眼压、治疗后眼压更平稳的优势。此外，与单药╱组分药物同时治疗相比，贝美素噻吗洛尔滴眼液组结膜充血不良反应率显著更低。
贝美素噻吗洛尔滴眼液的获批上市标志着该公司在青光眼药物治疗领域取得了重大进展，为公司的青光眼产品组合(目前包括合共七种药物及一款家用眼压测量仪器)开启新篇。
贝美素噻吗洛尔滴眼液是该公司第一款获药监局批准的仿制药物，也标志着公司正式步入管线产品商业化阶段。
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