华医的糖尿病药物Dorzagliatin在中国境外首次获得香港批准, 用于治疗二型糖尿病。
Hua Medicine’s diabetes drug dorzagliatin gains Hong Kong approval, its first outside China, for treating Type 2 diabetes.
Hua Medicine's Dorzagliatin的糖尿病药物以MyHOMSISQ出售,根据地区 " 1+ " 监管创新机制在香港获得市场批准,首次在中国大陆以外地区获得批准。
Hua Medicine's diabetes drug dorzagliatin, sold as MYHOMSIS®, has received marketing approval in Hong Kong under the region’s “1+” regulatory innovation mechanism, marking its first approval outside mainland China.
这种类型的第一种葡萄糖激酶激活剂,在中国自2022年以来获得批准,旨在通过增强胰岛素分泌和调节肝脏葡萄糖的产生来恢复葡萄糖平衡.
The first-in-class glucokinase activator, previously approved in China since 2022, is designed to restore glucose homeostasis by enhancing insulin secretion and regulating liver glucose production.
它被核准用作一线单疗法,或与2型糖尿病成年人的美信相结合。
It is approved for use as a first-line monotherapy or in combination with metformin for adults with Type 2 diabetes.
自2024年1月以来,它被列入中国国家报销名单,并向200 000多名病人开具了处方。
Since January 2024, it has been included in China’s national reimbursement list and prescribed to over 200,000 patients.
香港批准是扩展至东南亚及全球市场的战略举措, 并计划寻求澳门批准, 利用广东-香港-澳门大湾地区创新基础设施。
The Hong Kong approval is a strategic move to expand into Southeast Asia and global markets, with plans to pursue approval in Macao and leverage the Guangdong-Hong Kong-Macao Greater Bay Area’s innovation infrastructure.