In 2026, regulation, policy, institutions, and expertise are aligning to ensure Hong Kong can be a player in an extremely competitive Asian clinical trials landscape. From real-world data studies to groundbreaking early-stage work in vaccines, oncology, and even cell therapy, as well as some later-stage studies for niche indications, both Chinese and Western firms are taking note.
This ambition is anchored by a sophisticated clinical landscape comprising 43 public hospitals under a unified management system, two world-class medical schools, and five specialized Phase I Clinical Trial Centres accredited by international bodies. Perhaps most excitingly, with the Greater Bay Area International Clinical Trial Institute (GBAICTI) up and running, trial sponsors now have a one-stop-shop that allows sponsors access to the 87-million population of the wider Greater Bay Area region of southern China.
Hong Kong has long boasted robust clinical development fundamentals, as GBAICTI CEO Bernard Cheung explains. “Hong Kong has developed a strong and credible clinical research base over several decades with a modest overall scale but consistently high execution standards.”
Cheung continues, “Trials based in Hong Kong, conducted to international Good Clinical Practice standards, have contributed to the development of many medicines in use today, with data accepted by regulators in the United States, Europe, and the Chinese Mainland. That ability to support regulatory submissions across three major markets from a single jurisdiction is an important differentiator.”
An Anchor for Early-Stage Studies
Global names are looking to Hong Kong for clinical trials more than ever before, especially for early-stage studies. “We are seeing more international companies reassess Hong Kong as a base for early clinical development, particularly for focused proof-of-concept work,” notes Henry Yau, managing director of the University of Hong Kong Clinical Trials Centre (HKU-CTC). “Recently, a Swiss biotech – rather than launching a global trial immediately – planned a registry study followed by a Phase IIa proof-of-concept trial in Hong Kong, alongside a Phase I study initiated in the US,” outlines Yau.
“This type of strategy is increasingly common; early phase studies benefit from being tightly designed and operationally efficient, and Hong Kong offers strong investigators, relevant patient populations, and a system that allows sponsors to move quickly once decisions are made.”
Another example comes from across town at the Chinese University of Hong Kong; home to the other of the city’s Phase I trial centres. It was there, last year, that Swiss giant Roche broke new ground by becoming one of the first sponsors to recruit ethnically Chinese patients for a Phase I clinical oncology trial. “This milestone demonstrated that the city can conduct early-phase research to global standards and further strengthened our case for placing more studies here,” proclaims Amy Ho, general manager of Roche Pharma Hong Kong.
“Mainland China will always play an important role due to its scale and speed, but Hong Kong brings complementary strengths,” says Ho. “Data generated here are influential in global publications and scientific dialogue, and the expertise of local key opinion leaders adds significant weight to clinical advocacy. Our collaboration with Roche China and the China Innovation Centre of Roche (CICoR) also positions Hong Kong as an effective bridge between China-based innovation and global development pathways.”
And it is not just Western firms looking to early-stage trials in Hong Kong. With the massive growth of Chinese biotech in recent years, HKU-CTC’s Yau has seen larger Chinese companies becoming more eager to situate elements of their clinical development in Hong Kong. “In earlier years, most of our China-related activity involved smaller start-ups seeking data to support overseas expansion,” he states. “That pattern is changing, with more large mainland pharmaceutical companies now paying attention to Hong Kong and some beginning to establish a physical presence here. This suggests that Hong Kong is increasingly viewed not simply as a commercial market, but as a credible and efficient platform for early clinical development within a broader global strategy.”
Cell & Gene Therapy Potential
While oncology remains the leading therapeutic area for clinical trials in Hong Kong, recent years have also seen the growth of highly specialised modalities, including cell and gene therapies. These studies differ dramatically from more conventional trials; patient cohorts are often tiny, sponsors tend to be very small single-product biotechs, and – in such an emergent field – clinicians have very limited precedent to draw from.
“We are seeing increasing interest in gene therapy trials,” notes HKU-CTC’s Yau. “Hong Kong has deep clinical expertise in this field, supported by experienced investigators and an established patient base. That combination has attracted a growing number of international developers, often smaller biotechs.”
Yau explains that focusing on this niche “reflects a deliberate choice” for HKU-CTC, and indeed for Hong Kong as a whole. “Hong Kong’s compact healthcare system allows expertise and patients to be mobilised efficiently, which suits complex early phase work,” he points out. “Not every centre can run these studies, and sponsors are highly selective when placing first-in-human programmes. The fact that more companies are choosing to work with us in this area speaks to trust in our capabilities and to Hong Kong’s role as a credible platform for high value, early clinical development.”
Gina Jiang, managing director of the Hong Kong Institute of Biotechnology (HKIB) agrees, adding that “For Phase I gene therapy trials especially, patient numbers are often in the tens rather than the hundreds. You do not need large physical space or very large patient pools, and you can still generate high-quality data that is recognised internationally. If you combine this with manufacturing that meets international standards, this niche has real potential to flourish in Hong Kong.”
Jiang’s institute – the first in Hong Kong able to produce experimental cell and gene therapies for clinical trials – represents perhaps the most startling investment made by the Hong Kong government into this space. Last year, HKIB’s ATP GMP facility received a license to manufacture an experimental CAR-T therapy for large B-cell lymphoma. This is the latest milestone in a process that began in 2018 when Hong Kong’s Department of Health consulted the community on introducing CAR-T therapies locally, one year after the first FDA approval. An investigator-initiated clinical trial using these complex and highly personalised therapies – made by rewiring a patient’s own cells and reinfusing them into their bodies – is already underway, with 11 patients enrolled so far.
Given the glut of Chinese CAR-T developers that have emerged in recent years, and the price caps and genetic material regulation they face in their domestic market, Jiang feels that Hong Kong-based CAR-T trials – with HKIB at their heart – could be the key to wider international recognition. “Many Chinese CAR-T companies we speak with have a clear ambition to take their products to the global market,” she reflects. “Strategically, they see Hong Kong as a potential springboard.”
Opening Up for Late-Stage Trials
Beyond these investments in small, early-stage trials – Hong Kong’s traditional sweet spot, due primarily to its limited patient population – regulatory upgrades and increased integration with the GBA are making the city a more attractive destination for late-stage research. Notably, the ‘1+’ regulatory framework means that companies conducting local clinical trials in Hong Kong only need one approval from a reference country (like the US or EU) instead of two to register their drugs locally. The planned establishment of an independent regulator in Hong Kong conducting its own primary assessments should further strengthen the city’s case as a host for late-stage trials.
Moreover, Phase III trials in Hong Kong now serve as a springboard for the ‘Hong Kong-Macau Medicine and Medical Devices Connect,’ which allows drugs used in Hong Kong’s hospitals to also be administered in designated mainland hospitals within the GBA prior to full approval from China’s regulator, the NMPA.
One company leveraging this more favourable environment in Hong Kong and the GBA for late-stage trials is the German outfit Boehringer Ingelheim. Last year, the firm announced the first-ever clinical trial in Macau, a Phase IIIb study in lung disease, which it hopes to launch in the region in the next few years. As General Manager Joaquim Antunes Lopes notes, the market implications are clear.
“Essentially, if we want to bring innovation to market earlier, we need more local data. The more clinical trials we run locally, the more opportunities we have to introduce innovation earlier, and in a safe and responsible way.” He adds, “Data generated from local trials can support faster and more streamlined regulatory pathways. It also allows Hong Kong and Macau to participate as full contributors in global, multi-regional development programmes, rather than being seen as peripheral or late-stage markets.”
Real World Data
Another of Hong Kong’s most valuable assets for trial sponsors is its patient data. “Hong Kong has a unique asset in the Hospital Authority patient record system, which now contains 34 years of longitudinal data,” points out Sabrina Chan, senior executive at the Hong Kong Association of the Pharmaceutical Industry. “The system is unified under a single administrative framework, maintained in English, and supported by strong verification cohorts. Depending on how it is utilised, this data can support drug discovery, post-market surveillance, service enhancement, and enlistment decisions.”
British titan GSK is the most prominent global name to attempt to make use of this treasure trove of real-world data, inking a deal with the GBAICTI and HKU last year to establish a more structured approach to evidence generation in the city. “The aim is to integrate real-world data and clinical research across Hong Kong and the GBA so that decisions are supported by evidence that reflects both local needs and regional scale,” says Nicholas Teo, GSK’s general manager for Hong Kong and Macao.
As one of the world’s leading vaccine companies, GSK is keen to bolster the evidence base around its products as it looks to bring them to broader population sets, including in mainland China. “This framework enables us to examine outcomes that go beyond our vaccines’ direct efficacy, including cardiovascular, metabolic and even psychiatric dimensions, as well as wider impacts on well-being and productivity,” adds Teo.
The Greater Bay Area
Across all of the above themes, the prospect of somehow being able to meld the deep-seated expertise of Hong Kong with the scale, speed, and industrial might of the GBA is potentially transformative for clinical research in the region. Key to this effort is the GBAICTI, which as its CEO Bernard Cheung explains, “was not established as a response to gaps in capability, but to fragmentation.” Clinical research in Hong Kong had traditionally been distributed across universities, public hospitals, and individual investigators, with limited coordination at a system level. Therefore, as Cheung explains, “The Institute was conceived as a non-operational, one-stop platform that aligns stakeholders, streamlines processes, and removes avoidable friction, without duplicating the work of existing clinical trial centres or contract research organisations.”
He continues, “By linking Hong Kong and Macao with major mainland cities such as Guangzhou and Shenzhen, it creates a compact and well-connected region with a population of around 87 million. This area combines new hospital infrastructure, advanced technology, and a strong concentration of clinical and scientific talent drawn from across China. Efficient transport and short travel distances mean that patients and investigators remain close to study sites, which is unusual for a region of this scale.”
“The Institute’s role is to connect these complementary strengths. Hong Kong contributes established research standards, regulatory credibility, and an international orientation, while the wider GBA brings scale, infrastructure, and patient access. Rather than positioning itself in competition with established centres such as Beijing or Shanghai, the objective is to build a coordinated regional network that can operate at an internationally competitive level. Individually, institutions already perform well. Working together, the region has the potential to achieve a level of impact that none could reach alone.”
Hong Kong-based outfit Immuno Cure, for instance, is one company leveraging Hong Kong’s freshly updated clinical trial research infrastructure to help bring its HIV vaccine through Phase I trials. “Over the past two years, both the Hong Kong government and the Guangdong government established dedicated clinical trial research infrastructure designed to operate collaboratively,” explains Immuno Cure Co-Founder and CEO Xia Jin.
“Our HIV vaccine programme was selected as the first project to run through that joint system, which meant that what began as a local company initiative became a two-government project, elevated to the level of the Hong Kong and Guangdong administrations.” Having been designated a national project of strategic importance by the Chinese government, Immuno Cure’s upcoming Phase II HIV vaccine trial will run across five centres: one in Hong Kong, two in Guangzhou and Shenzhen, and two in Beijing.
Another company placing big bets on a more integrated GBA clinical trial ecosystem, is CK Life Sciences. HKEX-listed since 2002, the firm is investing heavily into R&D for cancer vaccines and other immunotherapies. While these assets are still in the preclinical stage right now, CEO Lance Yuen exclaims that “The GBA is becoming central to how we think about advancing our programmes. The region offers a large and relevant patient population, strong scientific and operational infrastructure and a supportive policy environment. The cancers we are targeting are also more prevalent in this part of Asia, which reinforces the rationale for progressing our candidates within the GBA as we move toward first-in-human studies.”
“We intend to work with HKU, CUHK and leading GBA hospitals to run coordinated, cross-boundary Phase I trials,” adds CSO Melvin Toh. “This gives us access to a broader and more representative patient base while keeping the development close to the scientific and operational ecosystem we are building in Hong Kong.”
Toh adds, “Speed is one of the hardest variables to control in drug development, especially in a place like Hong Kong, where both talent and patient numbers are more limited than across the border. For us, the key is to structure our programme so that we can enrol patients quickly and generate data that speaks to more than one population, because neither Hong Kong nor the United States can deliver that alone. The GBA provides the most practical solution, giving us access to a broader patient base while keeping us close to the scientific and regulatory networks we operate in.”
