Source: Hong Kong Government special administrative region – 4
Following is the speech by the Secretary for Health, Professor Lo Chung-mau, at the Biopharmaceutical Session of the Global Bay Area Economic Forum 2025 today (November 3):
Distinguished guests, ladies and gentlemen,
Good afternoon. It is my honour to join you at the Biopharmaceutical Session of Global Bay Area Economic Forum 2025. On behalf of the Health Bureau of the Hong Kong Special Administrative Region (HKSAR) Government, I extend my thanks to Our Hong Kong Foundation, the Guangzhou Institute of the Guangdong-Hong Kong-Macao Greater Bay Area, and the Macao Foundation for convening this meaningful dialogue.
In an era of complex global dynamics, the vibrant economic Global Bay Area clusters serve as engines of innovation and growth. Today, I will articulate the role and outlook of Hong Kong, not merely as a participant, but as a critical “super connector” within the biomedical innovation ecosystem of the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).
Just two years ago, in late 2023, the HKSAR Government articulated a clear and ambitious vision to develop Hong Kong into an international health and medical innovation hub. This was a strategic imperative, supported by our nation’s 14th Five-Year Plan. This vision aligns perfectly with the decisions of the Third Plenary Session of the 20th CPC Central Committee, which emphasised deepening healthcare reform and establishing robust mechanisms to support innovative drugs and medical devices. The HKSAR is uniquely positioned to advance these national priorities, with our intrinsic strengths such as our international connectivity, rule of law, high-quality and efficient healthcare systems, robust data integrity, world-leading financial centre, and life-science research backed by two of the world’s top medical schools.
We are systematically transforming that vision into tangible reality in the GBA. A world-class biomedical innovation hub requires a world-class regulatory regime. We embarked on a landmark reform towards primary evaluation for medical products. Our first step was the launch of the “1+” mechanism in November 2023, which allows new drugs supported by local clinical data, to be registered in Hong Kong with approval from just one reference regulatory authority, instead of two. Today, we have already approved 15 new drugs under this mechanism, with seven of them being listed on the Hospital Authority (HA) Drug Formulary, bringing real benefits to patients.
In June this year, we announced a roadmap to establish the Hong Kong Centre for Medical Products Regulation next year, with a view to establishing the centre as an internationally recognised regulatory authority for medical products. we will start implementing “primary evaluation” for new drug registration in phases. To further accelerate patient access to the most advanced treatments, we will also pilot a priority evaluation and approval of innovative drugs recommended by the HA for treatment of clinically urgent, severe or rare diseases. Furthermore, the HA is establishing a dedicated Office for Introducing Innovative Drugs and Medical Devices. It will proactively facilitate the entry of innovative, cost-effective treatments into Hong Kong, ensuring our patients are among the first to benefit from global breakthroughs.
The Greater Bay Area International Clinical Trial Institute (GBAICTI), which we envisioned in 2023, is now fully operational in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone. Operating under the innovative “one zone, two parks” model with our Shenzhen counterparts, BAY TRIAL (Greater Bay Area International Clinical Trials Center) in Shenzhen park, the GBAICTI combines Hong Kong’s world-class clinical standards, data integrity, and international recognition with the vast patient population and diverse disease profile in the GBA.
In May this year, the GBAICTI started a partnership with the medical faculties of the University of Hong Kong (HKU) and the Chinese University of Hong Kong to provide comprehensive support for over 70 new clinical trial projects in the coming year. This will effectively consolidate Hong Kong’s world-class research capabilities into a unified force.
At the same time, we establish collaboration across the boundary. In July, the GBAICTI signed a pivotal MOU with its Shenzhen counterpart, the GBA International Clinical Trials Center, or BAY TRIAL, and established a unified GBA Clinical Trial Collaboration Platform. This platform streamlines matching services through artificial intelligence, provides a one-stop platform for applications, protocol approval and execution; and builds shared talent pools. This partnership has already yielded its first major project, a cross-border Phase II clinical trial for ICVAX, a therapeutic HIV vaccine co-developed by ImmunoCure and the AIDS Institute of HKU.
The Real-World Study and Application Centre is set to launch by the end of this year. Its core function is to systematically harness the high-quality and comprehensive real-world data from Hong Kong’s public healthcare system, which covers over 11 million patient records.
The Centre will provide robust real-world evidence to support multiple functions, such as to accelerate the development, regulatory approval, and market access of innovative medical products, particularly through data integration across the GBA. A key part of this strategy is the establishment of a unified GBA Real-World Data Platform, which will standardise and connect clinical data from both sides of the boundary, creating a seamless data ecosystem.
Ladies and gentlemen, the biomedical innovation landscape is rapidly evolving, and so are we. Over the past two years, we have systematically transformed vision into infrastructure, infrastructure into capability, and capability into tangible results – 15 new drugs approved, over 70 clinical trials in the pipeline, and a regulatory body ready to serve the region and the world. But our ambition extends beyond our shores. We envision Hong Kong as the nexus where Eastern and Western medical innovation converge.
For international companies, we offer a trusted gateway: conduct trials here under globally accepted standards with patients recruited from the 86 million population in the GBA. Our legal framework, intellectual property protection, and capital mobility provide the confidence needed for bold investment. For our nation’s burgeoning biotech sector, we provide the springboard to the world: leverage our ecosystem to conduct international multicentre trials, access global capital markets, and use Hong Kong registration as your passport to international markets.
Hong Kong will continue to strengthen its role as the unparalleled “super connector” in the global biomedical landscape, building a healthier future for the region and the world. The Government’s good efforts need the support of the community. The Legislative Council (LegCo) election day, the important day, will be on December 7 this year. We will be electing a highly competent and supportive LegCo for the new term. And hopefully, the new LegCo will work with the Government together and with all the stakeholders here to drive Hong Kong into an international health and medical innovation hub. Thank you so much and I wish you a wonderful afternoon. Thank you.