The global first-in-class drug dorzagliatin, developed by Hua Medicine-B (ASX: 02552), has received approval for market launch in Macau from the Macau Pharmaceutical Administration. This approval is for the treatment of adult type 2 diabetes.

This milestone marks the drug's availability across three key regions: Mainland China, Hong Kong, and now Macau. It stands as the first domestically developed, first-in-class diabetes drug to receive approval across the entire Guangdong-Hong Kong-Macao Greater Bay Area.

Dorzagliatin is an allosteric glucokinase activator. Its mechanism of action involves repairing the impaired glucokinase function in patients with type 2 diabetes, thereby enhancing glucose sensitivity, improving beta-cell function, reducing insulin resistance, and restoring glucose homeostasis regulation from the source.

The drug was initially approved in Mainland China in September 2022, was included in the National Reimbursement Drug List in 2024, and gained approval in Hong Kong in February 2026. Since its launch in the mainland, it has reached over 500,000 patients through more than 3,000 hospitals, community health centers, pharmacies, and online channels.

Dr. Chen Li, Founder and CEO of Hua Medicine, commented that the successful approval in Macau benefits from the region's continuously optimized market access mechanisms for innovative drugs and the strong support from the Macau SAR government for pharmaceutical innovation. He described this as a critical step for the company's expansion into Portuguese-speaking countries and global markets, validating the robust competitiveness of China's independently developed innovative drugs.

Cao Beili, Vice President of Group Operations and Greater Bay Area Development at Hua Medicine, highlighted that this represents significant progress in advancing the coordinated development of pharmaceutical innovation within the Greater Bay Area and improving regional access to China's original innovative drugs.

In Macau, diabetes poses a major public health challenge. According to Macau's Health Bureau, the number of registered diabetes patients in Macau reached approximately 44,000 in 2024, a 45% increase from 2018.

The successful launch of dorzagliatin in Macau not only provides new treatment options for local patients but also signifies Hua Medicine's strategic use of Macau's unique role as a hub between China and Portuguese-speaking countries. This marks the formal beginning of its crucial steps toward entering Portuguese-speaking markets and expanding its global reach.

On June 29, the company announced that its wholly-owned subsidiary, Hua Medicine Technology (Hong Kong) Limited, has deepened its collaboration with market expansion services provider DKSH Hong Kong. Leveraging DKSH's extensive distribution network, professional market expansion capabilities, and end-to-end service model, its Healthcare business will support Hua Medicine in achieving efficient expansion and accelerating the commercialization process of its products in the Hong Kong market.

Looking ahead, Hua Medicine plans to use Macau as a strategic starting point to explore registration, application, and commercialization pathways in Portuguese-speaking countries, aiming to serve large diabetic populations in regions such as Brazil. The company seeks to build a multi-dimensional market coverage network rooted in China and extending to Southeast Asia and Portuguese-speaking nations.

Concurrently, through the deepened partnership with DKSH, the companies will combine their respective strengths in innovative drug development and market expansion. They aim to jointly advance the commercialization of related products in the Hong Kong market and continuously enhance regional healthcare accessibility.