Recently, Dorzagliatin, an innovative type 2 diabetes drug developed by Hua Medicine, has been approved for marketing by the Office of Pharmaceutical Products, Department of Health, Hong Kong Special Administrative Region. It has become the first general drug (a widely used medicine for common diseases) approved under Hong Kong’s “1+” Fast Track Approval Mechanism for new drugs. In 2023, the Shanghai-based enterprise highlighted through this newspaper the difficulties faced by domestic innovative drugs in seeking market approval in Hong Kong. Today, its wish has been fulfilled, as the innovative drug has been approved via the “direct access” route in Hong Kong. Holding both mainland and Hong Kong drug registration certificates, the company plans to expand to Southeast Asia, opening up broad overseas markets for domestic innovative drugs.

For a long time, Hong Kong implemented the “2+” Approval Mechanism, which required new drugs to be first launched in two “listed countries” before registration applications could be filed in Hong Kong. The vast majority of countries on this list are developed nations. As a result, innovative drugs approved in mainland China had to first seek registration in those countries, creating significant barriers to entering the Hong Kong market.

Dr. Chen Li, Founder and Chief Executive Officer of Hua Medicine, told reporters that this system was formed due to historical reasons. China was once a major country in generic drugs, with a considerable gap in innovative drug R&D and registration compared with some developed countries. However, over the past decade, China’s biomedical R&D capabilities have risen rapidly, and domestic innovative drugs have continued to emerge. In 2017, China’s drug regulatory authority joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), aligning its registration standards with those of developed countries.

To Dr. Chen’s delight, in November 2023, the Department of Health launched the new “1+” Approval Mechanism for new drugs, under which new drugs for serious or rare diseases (specialty drugs) can apply for registration as long as they have been approved in one “listed country”, which now includes China’s National Medical Products Administration. Although Dorzagliatin, as a general drug, was not initially covered by this policy, the institutional reform had begun. One year later, Hong Kong extended the “1+” mechanism to all new drugs.

In early 2025, Hua Medicine submitted recommendations from medical experts in Hong Kong and the Chinese mainland to the Department of Health of the Hong Kong Special Administrative Region. In September, the application for marketing approval of Dorzagliatin was officially accepted. Following more than 10 rounds of review and correspondence, the evaluation process was completed in February this year. This month, the company announced the good news that Dorzagliatin will benefit diabetes patients in Hong Kong.

Going forward, Hua Medicine will use Hong Kong as an offshore hub to explore the Southeast Asian market with a total population of approximately 700 million. “Hong Kong, China maintains close regulatory connections with Singapore, Thailand, the Philippines and other countries. With drug registration certificates from both the Chinese mainland and Hong Kong, we can more easily access the new drug registration pathways in these markets, taking a critical step in our global layout,” Dr. Chen said: This internationalization strategy provides a valuable reference for Chinese pharmaceutical companies: after being launched in the Chinese mainland, domestic innovative drugs can apply for approval in Hong Kong, and then expand to Southeast Asia with the “two certificates”, bringing new treatment options to numerous patients worldwide.