Three other new drugs approved under "1+" mechanism for benefits of good drugs
A Government spokesman announced today (August 28) that three more new drugs submitted for registration under the new drug approval mechanism ("1+" mechanism) have been approved for registration in Hong Kong. These three new drugs are respectively used to treat patients with thyroid eye disease, recurrent or metastatic cervical cancer and severe hemophilia A or B, bringing more treatment options for patients and facilitating the availability of more good drugs for use in Hong Kong.
Three new drugs approved
The Hong Kong Special Administrative Region (HKSAR) has implemented the "1+" mechanism since November 1, 2023, to facilitate the registration of new drugs used for the treatment of life-threatening or severely debilitating diseases in Hong Kong. With effect from November 1 last year, the "1+" mechanism has been extended to all new drugs, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can be applied for registration in Hong Kong by submitting approval from one reference drug regulatory authority (instead of two in the past).
The above three products have been approved by the drug regulatory authority in the United States and submitted for registration applications under the "1+" mechanism. Having evaluated the clinical data and relevant information submitted by the applicant and advice given by local experts, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considered that the new drugs satisfied the criteria of safety, efficacy and quality, and approved the registration of the new drugs. The Department of Health (DH) has already notified the applicants of the results of the applications.
Paving the way towards "primary evaluation"
Since the implementation of the "1+" mechanism, a total of 14 new drugs, including the above three drugs, have been approved under this mechanism. Five of them have been listed in the Hospital Authority Drug Formulary. The DH has been promoting the "1+" mechanism through different channels and so far has received more than 620 enquiries from over 160 pharmaceutical companies, including those from overseas and the Mainland. Many companies have expressed interest in submitting applications for registration of their products, including advanced therapy products, under the extended "1+" mechanism. Since the launch of the consultation service for new drugs applications under the "1+"mechanism in March this year, the DH has already held a number of briefing seminars and workshops. The DH will also have pre-new drug application meetings with potential "1+" registration applicants, starting from the fourth quarter of this year, to enhance the efficiency in processing relevant applications.
The "1+" mechanism serves to attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards "primary evaluation", i.e. to directly approve applications for registration of drugs and medical devices based on clinical data in Hong Kong, without relying on other drug regulatory authorities.
The Hong Kong Centre for Medical Products Regulation will be established by the end of next year, and the DH will implement "primary evaluation" for new drug registration in phases beginning next year, with full implementation by 2030. The DH will continue to proactively advance preparatory work for "primary evaluation" for new drug registration and progressively establish a robust approval system for medical products, providing strong momentum for the development of healthcare in the HKSAR, the Mainland, and beyond, thereby transforming Hong Kong into an international health and medical innovation hub.
Source: AI-found images
Speech by CE at 2026 WAIC UP! Global Summit (with video)
Following is the video speech by the Chief Executive, Mr John Lee, at the 2026 WAIC UP! Global Summit today (January 16):
Distinguished guests, friends from the world of AI, ladies and gentlemen,
A very warm welcome to Hong Kong. It is a pleasure to join you today, at this year's WAIC UP! Global Summit.
A gathering that brings together top experts, industry pioneers and academic leaders, the WAIC UP! Global Summit is a platform under the renowned World Artificial Intelligence Conference. I'm glad to add that the Summit is held for the very first time in Hong Kong this year. The theme of this Summit, "WAKE UP MORE!", underscores the infinite possibilities of artificial intelligence. We must harness the power of AI, not just to innovate, but to build - to build more inclusive economies, more resilient communities, and a more sustainable future for all.
The Recommendations of the Central Committee of the Communist Party of China for Formulating the 15th Five-Year Plan for National Economic and Social Development supports Hong Kong's development into an international innovation and technology (I&T) centre, as well as an international hub for high-calibre talent.
Hong Kong is moving at full steam to develop into an international I&T centre. Central to this vision is our commitment to advancing the development of AI. Our approach is multifaceted, built upon the solid pillars of government investment, world-class research, strategic infrastructure, and a dynamic, open market.
Under the unique "one country, two systems" principle, Hong Kong is the only world city that converges both the China advantage and the global advantage. We are also the only city that counts as many as five universities in the world's top 100. Our institutions equip Hong Kong's next generation with the versatility and knowledge key for future development. They also bring together a world of academics, researchers and talent to contribute to our ever-growing research and innovation capabilities.
We reached a significant milestone in our innovation journey, just last month, with the official opening of the Hong Kong Park of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone. We will develop the Hong Kong Park into a world-class hub for technological innovation that connects the Mainland with the international community. It will become an important source for fostering and advancing new quality productive forces for China, our country.
Accelerating the flow of talent, data and capital, the Hong Kong Park will allow AI projects to rapidly progress from fundamental research in Hong Kong, to commercialisation and large-scale application in the broader market.
Last September, we launched the Frontier Technology Research Support Scheme to subsidise universities in attracting top-notch scientific researchers from the world in AI, and other fields, to come to Hong Kong to spearhead basic research in frontier technologies.
We have also earmarked HK$1 billion for the establishment of the Hong Kong AI Research and Development (R&D) Institute this year, to facilitate upstream AI R&D, the midstream and downstream R&D outcomes, and the expansion of use cases.
In addition, we have taken a concrete step within the HKSAR (Hong Kong Special Administrative Region) Government by establishing a new AI Efficacy Enhancement Team. More than just showcasing our resolve to AI development, this team has a clear mission - to co-ordinate all government departments in applying AI technology, and to explore process re-engineering and promote technological reform. This will significantly improve government efficacy to better meet public demands, through the important tool of AI.
Ladies and gentlemen, in this era of rapid technological transformation, Hong Kong is in a distinct position. With the robust rule of law, a welcoming business environment, and a vibrant multicultural setting, Hong Kong is the perfect incubator for scientific exploration and technological breakthroughs.
Let us leverage today's summit as a springboard for deeper partnerships. Together, we can pioneer the technologies, establish the standards, and forge the future we wish to see - an AI-empowered future that is equitable, sustainable, and prosperous for all.
I wish you all a most fruitful and inspiring summit. Thank you very much.
Source: AI-found images
