Speech by Secretary for Health at Opening Ceremony of BIOHK2025 (English only)
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Mr C Y Leung (Vice-Chairman of the National Committee of the Chinese People's Political Consultative Conference), Professor Sun Dong (Secretary for Innovation, Technology and Industry), Professor Albert Yu (Chairman of the Hong Kong Biotechnology Organization (HKBIO) and President of BIOHK2025), distinguished guests, ladies and gentlemen,
It is a pleasure to join you all again at BIOHK2025. On behalf of the Health Bureau of the HKSAR (Hong Kong Special Administrative Region) Government, I would like to welcome all delegates to the BIOHK2025 and thank the Hong Kong Biotechnology Organization for creating this exceptional platform that brings together the brightest minds in biotechnology from East and West.
Last year at this very convention, I shared with you our resolute mission: to transform Hong Kong into an international health and medical innovation hub. Today, I am delighted to give you a quick update on the significant strides we have made, turning that vision into tangible action and reinforcing Hong Kong's role as a "super-connector" in the global biotech landscape.
Our commitment is unwavering. Hong Kong's unique position in biotech is reinforced by national policies, including the 14th Five-Year Plan, which designates Hong Kong as an international innovation and technology hub. We are pressing ahead with the reform of the regulatory framework for drugs and medical devices to facilitate the translation and application of biomedical innovations.
To this end, we have achieved several key milestones:
First, we implemented the "1+" mechanism in November 2023, which has been extended to all new drugs last year. Since implementation, 14 new drugs have been approved. Five of them have been listed in the Hospital Authority Drug Formulary.
Second, to enhance the efficiency in processing relevant applications, a consultation service for new drug applications under the "1+" mechanism was launched in March this year.
Third, in June this year, we announced the roadmap and timetable for implementing "primary evaluation" for new drug registration by phases beginning next year and establishing the Hong Kong Centre for Medical Products Regulation by the end of next year.
Fourth, the Greater Bay Area International Clinical Trial Institute (GBAICTI), which we launched in Hetao last November, is now fully operational. The simultaneous launch of the GBAICTI and the Greater Bay Area International Clinical Trials Center in Shenzhen marked the beginning of a new chapter in cross-boundary collaboration under the "one zone, two parks" model. The GBAICTI is already actively advancing clinical trial projects and, to complement this, the Government is seeking to establish the Real-World Study and Application Centre by the end of this year to accelerate the research and development, approval and market launch of innovative medical products.
Ladies and gentlemen, these initiatives are creating a vibrant and supportive ecosystem for the entire biotechnology industry. Last year, I encouraged you to participate actively in Hong Kong's health and medical innovation landscape. Today, that invitation is stronger than ever. Whether you are seeking to conduct cutting-edge clinical trials, navigate new regulatory pathways, or enter the vast Greater Bay Area market, Hong Kong is your perfect choice.
On that note, I wish you all a fruitful and inspiring convention. Thank you.
Ends/Wednesday, September 10, 2025
Issued at HKT 11:50
Issued at HKT 11:50
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