HUA MEDICINE-B's Flagship Product Hualing Tablet® Approved in Hong Kong, Launching New Global Expansion

Stock News
Mar 04

HUA MEDICINE-B (02552) has reached a pivotal moment in its global strategy. The company announced that its globally first-in-class innovative drug, the glucokinase activator (GKA) dorzagliatin (brand name: MYHOMSIS®, Hualing Tablet®), has received approval from the Hong Kong Department of Health for marketing. It is indicated for the treatment of type 2 diabetes in adults. This achievement not only adds a significant milestone to HUA MEDICINE's value trajectory but also marks a crucial step for the company in using Hong Kong as a hub to enter the Southeast Asian and global markets. The approval of Hualing Tablet® in Hong Kong leverages the city's "1+" innovative drug regulation mechanism, making it the first innovative drug for chronic metabolic diseases approved under this framework. This not only reflects Hong Kong's policy support for innovative medicines but also demonstrates the global competitiveness of Chinese-developed drugs like dorzagliatin. In fact, as the world's first innovative drug targeting the glucokinase (GK) mechanism, dorzagliatin has already gained authoritative recognition domestically. It was launched in mainland China in 2022 and was included in the National Reimbursement Drug List for the first time in 2024, after which its market penetration accelerated. It has also been incorporated into several authoritative clinical guidelines and consensus documents for diabetes and is featured in the 10th edition of the "Internal Medicine" textbook, establishing it as a preferred clinical treatment option. The approval in Hong Kong further validates the drug's innovative strength and clinical value, receiving recognition from both capital markets and regulatory agencies. From the perspective of the local Hong Kong market, the launch of dorzagliatin is expected to invigorate diabetes diagnosis and treatment locally. Hong Kong boasts a comprehensive diabetes management system with a full-chain layout covering monitoring, prevention, treatment, and community management, supported by an effective community-based public-private collaboration model. Dorzagliatin offers unique clinical advantages, such as enhancing patients' glucose sensitivity and improving glycemic homeostasis dysregulation, which aligns well with Hong Kong's sophisticated diagnostic and treatment needs. Following its launch, the drug will integrate deeply with the local healthcare system, utilizing personalized treatment plans to help improve patients' quality of life, control disease progression, and alleviate the local healthcare burden. On the research and development front, HUA MEDICINE is collaborating with a team led by internationally renowned endocrinology expert Professor Juliana Chan of The Chinese University of Hong Kong to conduct the SENSITIZE series of studies, aiming to further explore dorzagliatin's therapeutic potential. Moving forward, the company plans to continue partnering with top-tier scientific research institutions in Hong Kong to investigate the drug's value in pre-diabetes intervention, early treatment, and complication prevention. These efforts will help accumulate international clinical data, lay the groundwork for expanding indications, and establish personalized intervention and treatment management plans for patients with pre-diabetes and type 2 diabetes. Furthermore, Hong Kong serves as a core hub for the Greater Bay Area and Asian markets, with regulatory standards aligned internationally, well-developed medical infrastructure, strong connections to Southeast Asian markets, and a mature financial capital market. Seizing this opportunity, HUA MEDICINE aims to leverage Hong Kong's medical credibility and international influence to expedite the drug's registration and application processes in markets such as Macau, China, and Southeast Asia, thereby reaching a larger population of diabetic patients. Concurrently, the company intends to use Hong Kong as a base to build a global sales network and R&D collaboration system, deepen partnerships with international pharmaceutical industry chain players, accelerate the commercialization of dorzagliatin, and continue to expand its global growth potential. Overall, the approval of Hualing Tablet® in Hong Kong represents a critical step for HUA MEDICINE in evolving from a "China-originated research" entity to a "global innovation" leader. This milestone not only broadens the accessibility of its core drug within the Greater China region, enhancing the resilience of the company's long-term profitability, but also secures a key strategic position in the global market layout. Looking ahead, as commercialization efforts deepen and the international strategy progresses, HUA MEDICINE is poised to enter a new phase driven by both performance and valuation, with its innovative value set to be further unleashed, opening up new ceilings for long-term growth.

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