Core Viewpoint - The acceptance of the New Drug Application (NDA) for dorzagliatin by the Hong Kong Department of Health marks a significant milestone for the company in expanding its market beyond mainland China, aiming to address the urgent health challenges of diabetes in Asia [2][3]. Group 1: Drug Approval and Market Expansion - The NDA for dorzagliatin has been officially accepted, which is seen as a crucial step in the company's strategy to reach more patients in Asia and eventually the global market [2]. - Over 500,000 people in Hong Kong and nearly 240 million people in Asia suffer from diabetes, highlighting the importance of dorzagliatin in addressing these health issues [2]. - The new "1+" mechanism in Hong Kong's drug approval system allows for a streamlined process, requiring only one reference drug approval instead of two, facilitating faster access to new medications [2]. Group 2: Clinical Value and Future Potential - Dorzagliatin was approved in mainland China in September 2022 and is included in the National Medical Insurance Drug List effective January 1, 2024, for treating type 2 diabetes [3]. - The CEO of the company emphasized that the acceptance of the NDA in Hong Kong is not only a recognition of the drug's clinical value but also a significant step in the company's internationalization process [3]. - Hong Kong's unique position as a medical leader and financial hub makes it an ideal gateway for expanding the influence of dorzagliatin into Southeast Asia and beyond [3].
华领医药：多格列艾汀在中国香港的新药上市申请获受理