Shanghai firm's innovative diabetes drug gains approval in HK

​Dorzagliatin offers a new treatment option for diabetes patients. [Photo/Shanghai Observer]

Shanghai-based Hua Medicine's innovative type 2 diabetes drug, Dorzagliatin, has received approval for marketing from the Drug Office of Hong Kong's Department of Health, making it the first general medicine approved under Hong Kong's new "1+" drug approval mechanism.

Previously, Hong Kong required new medicines to secure approval in two countries included in a "list of reference countries for registration of pharmaceutical products", primarily developed economies, before they could be registered in Hong Kong.

Under the "2+" drug approval mechanism, innovative drugs developed in Chinese mainland had to first apply for registration in at least one of those reference countries before entering the Hong Kong market, which proved challenging.

Chen Li, founder and CEO of Hua Medicine, said, in the past, Chinese mainland pharmaceutical companies mainly focused on generic drugs production, lagging behind developed countries in research and development of innovative drugs.

However, over the past decade, Chinese mainland's biomedical R&D capabilities have rapidly improved, with many domestically produced innovative drugs developed, Chen said.

Dorzagliatin is a prime example of such domestically developed innovative drugs. Born in Zhangjiang area of Shanghai, it is an oral anti-diabetic medication, which can enhance glucose sensitivity in diabetic patients and help restore glucose homeostasis.

Hong Kong launched its "1+" new drug approval mechanism in November 2023, initially targeting treatments for severe or rare diseases, before extending it to all new drugs.

Hua Medicine submitted the application to the Hong Kong Department of Health in early 2025, which was formally accepted in September. The review process was completed in February.

The company plans to leverage Hong Kong as a gateway to expand into Southeast Asia, a market of around 700 million people.