Hua Medicine-B (02552) has announced that its first-in-class glucokinase activator (GKA) drug, dorzagliatin (brand name: MYHOMSIS®, Hua Tablet®), has received marketing approval from the Drug Office of the Department of Health of the Hong Kong Special Administrative Region for the treatment of adult type 2 diabetes. Under Hong Kong's "1+" innovative drug regulatory mechanism, the New Drug Application (NDA) for dorzagliatin was formally accepted by the Hong Kong Department of Health in September 2025 and has now been approved. As the first innovative drug for chronic metabolic disease to be approved since the implementation of the "1+" mechanism, the successful launch of dorzagliatin not only provides a new treatment option for type 2 diabetes patients in Hong Kong but also marks a critical step in Hua Medicine's strategic plan to use Hong Kong as a hub for formally entering the Southeast Asian and global markets from China. Dr. Chen Li, Founder, Executive Director, and CEO of Hua Medicine, stated: "The approval of dorzagliatin in Hong Kong is a significant milestone in the company's development. As one of the first innovative originator drugs to benefit from Hong Kong's '1+' mechanism, this achievement reflects Hong Kong's support for innovative medicines and validates the global competitiveness of China's independently developed innovative drugs. The Hong Kong launch is a key step for Hua Medicine's expansion into Southeast Asian and international markets. We will use Hong Kong as a hub to build a marketing network and R&D collaboration system that radiates across Southeast Asia and connects globally, bringing China's independently developed innovative drugs to diabetic patients in more countries and regions. Concurrently, we will continue to advance the launch process for dorzagliatin in the Macao Special Administrative Region to achieve full coverage in the Guangdong-Hong Kong-Macao Greater Bay Area and deepen cooperation with local scientific research teams to continuously explore new frontiers in diabetes treatment."