Almost a decade on from the establishment of a Phase I clinical trial centre in Hong Kong, the city continues to pursue a stronger positioning within the global clinical research landscape. Strengthened by its experience in conducting COVID-19 vaccine trials, the global trends towards clinical research in Asia and more diverse trial cohorts, as well as increasing integration across the wider Greater Bay Area (GBA), Hong Kong is placing big bets on highly technical clinical research ventures. These include a good manufacturing practice (GMP) manufacturing facility for cell and gene therapies as well as its own genome project.
Stronger than Ever
Between 2017 and 2022, the number of clinical trials situated in the Asia-Pacific region grew by around 10 percent, far exceeding the overall average growth of 5.3 percent per annum as well as that of other major regions including the US, Europe, and Rest of World. Today, clinical research organisation Novotech and GlobalData estimate that over half of the 27,000 clinical studies initiated in 2021 had locations in APAC.
Within this context of the increased global relevance of its wider region, Hong Kong has been carving out a niche for itself as the upper end of the clinical research value chain. The University of Hong Kong Clinical Trials Centre (HKU-CTC) has been critical in this transformation since the establishment of its Phase I Centre in 2014, as has the Clinical Research Management Office at the Chinese University of Hong Kong (CUHK CRMO). Prior to that point, most clinical trials taking place at HKU-CTC were later stage Phase III trials but today, as the institute’s managing director, Henry Yau, notes, a significant number of the 70 to 80 new trials taking place at HKU-CTC every year are Phase I and II.
He outlines, “We now have a dedicated facility with 24 beds, enabling us to efficiently recruit healthy volunteers and patients for Phase I and early phase trials. As we continue to expand our capabilities and expertise in conducting these early phase trials, we are attracting more pharmaceutical companies and research institutions seeking to conduct innovative and cutting-edge research in Hong Kong. Our focus on early phase trials allows us to contribute significantly to the translation of medical discoveries and the development of new therapies, positioning HKU-CTC as a key player in the evolving landscape of clinical research.”
Our focus on early phase trials allows us to contribute significantly to the translation of medical discoveries and the development of new therapies, positioning HKU-CTC as a key player in the evolving landscape of clinical research
Henry Yau, HKU-CTC
Legendary researcher Professor Paul Tam, whose team at the Macau University of Science and Technology (MUST) is currently working on a human surrogate platform for preclinical studies, adds that the HKU-CTC acts as “a one-stop service for its partners. Pharmaceutical companies reach out to them, and then they are linked with relevant local experts to set up contracts and procedures for Phase I, II and III trials to be conducted, both internationally and in China.”
Despite the diminutive size of Hong Kong and its 7.4 million population, multinational pharma companies have long seen the city as a reliable node in their global trial networks. “Hong Kong has many world class professors and doctors in areas such as cardiovascular and oncology,” says Derek Chang, head of Novartis Hong Kong. “We have used Hong Kong many times over for global Phase I and II studies thanks to the excellent healthcare professionals here, strong researchers, top-class universities, and well-functioning healthcare system.”
“Hong Kong has world-class hospitals and universities, five of them being in the global top 100 with lots of international investigators,” adds Sabrina Chan, senior executive director of the Hong Kong Association of the Pharmaceutical Industry (HKAPI). “The GBA gives us the advantage of a sizable patient pool, something Hong Kong does not boast on its own and the Hong Kong Hospital Authority (HA) has maintained and stored the health records of 90 percent of inpatients for the last 31 years, which is a very good source of patient data. Hong Kong must now develop a method of leveraging this data to undertake clinical studies.”
Biotech outfits from mainland China are also beginning to see Hong Kong as a valuable research location. While these companies have tended to base their clinical trials in the US with an eye on later access to the world’s largest market, players like HKEX-listed RNA therapeutics biotech Sirnaomics are now looking to leverage some of Hong Kong’s clinical trial fundamentals and situate a greater proportion of their clinical research efforts closer to home. While the firm first filed investigational new drug applications (INDs) with the US FDA and conducted clinical trials in the US, Executive Director & Chief Strategy Officer Dr Dai Xiaochang explains that “once we have proof of concept, we will then expand into multi-centre international trials in countries and regions like Singapore, Hong Kong, Taiwan, and mainland China. We are currently evaluating clinical sites in Hong Kong and Singapore.”
He adds that “Liver disease is prevalent in Asia. Therefore, our candidate STP707 will have significant clinical trials running in Asia for liver and other GI-related tumours. We have received research funding support from the Hong Kong Special Administrative Region (HKSAR) for these studies and as a listed company, Sirnaomics will also take full advantage of the capital market to raise funds to support future development.”
Advanced Therapy GMP Manufacturing: Filling a Global Gap
One gap in the city’s clinical trials ecosystem that has only recently been filled is that of a GMP lab to manufacture clinical trial materials. As Qiming Venture Partners Managing Partner Nisa Leung points out, “Hong Kong has four Phase I clinical centres but up to now no GMP lab. Also, it has a lot of world-class professors, but they may lack of experience in translational research, which hinders their R&D work from reaching the clinic.”
She continues, “however, one of our portfolio companies has recently set up a joint venture with the Hong Kong Science Park. They have constructed and will operate Hong Kong’s first GMP lab. They have already conducted some 700 clinical studies, and have won Chinese, US and European certifications. Now, they are building their team here to undertake clinical research in Hong Kong. Clinical trials are a good first-step for the next stage development to build a biotechnology ecosystem. Exciting times are ahead.”
Regenerative medicine is booming, and more than 60,000 patients are currently participating in cell and gene therapy clinical trials, yet the average waiting time to access a GMP clean room to produce the products needed is 18 months
Gina Jiang, HKIB
Gina Jiang, managing director at the Hong Kong Institute of Biotechnology (HKIB) under CUHK, where the new facility will be located, adds that the recent completion of this advanced therapy products (ATP) GMP centre helps solve a global bottleneck in the production of cell and gene therapies. “Regenerative medicine is booming, and more than 60,000 patients are currently participating in cell and gene therapy clinical trials, yet the average waiting time to access a GMP clean room to produce the products needed is 18 months. The backlog of many of these trials is actually occurring at the GMP facility, so HKIB chose to build this ATP GMP site to help fix this bottleneck situation as well as develop new therapies.”
The pharmaceutical industry’s increasing prioritisation of clinical trial diversity, including initiatives from associations like PhRMA in the US and the IFPMA globally, may also serve to further bolster Hong Kong’s clinical trial footprint. As Yau explains, “many pharmaceutical companies are choosing Hong Kong as a location for their trials with the intention of eventually entering the mainland China market. This trend is particularly evident for drugs developed by US or European pharmas, which typically start their trials with Caucasians from North America or Europe. However, to cover the global populations, they also go to other regions including Asia to collect data that demonstrates safety, efficacy, and pharmacokinetics relevant to those populations. Such data is crucial for preparing drug registrations, particularly in Asian countries where local data is highly valued for regulatory purposes.”
He adds, “Some companies may specifically approach us in Hong Kong to conduct Phase I trials for pharmacokinetics and safety evaluation in the Chinese population, and subsequently proceed to conduct additional trials in mainland China to meet the marketing registration requirements there. The demand for Chinese data for drug approvals in mainland China is one of the significant factors attracting clinical trials to Hong Kong.”
There is, however, a long road to travel to fully establish Hong Kong as a stronger player in global clinical research efforts. Professor LO Yuk Lam, a veteran of the city’s biotech scene and currently president of the HK Bio-Med Innotech Association laments that Hong Kong has “no clinical trial-specific hospitals and only three certified hospitals. Also – and this is nobody’s fault – Hong Kong is small and does not have a large enough population for many clinical studies. Another point is that we have an excellent public healthcare system with great doctors, but they are primarily driven to help the patients in front of them and have no interest in research. They could change their mindset, and maybe being part of more clinical studies will help, but this takes a lot of time and a shift in mentality.”
The Hong Kong Genome Project: A Game Changer?
Another example of how Hong Kong’s strong but previously disparate clinical research efforts are being corralled towards medical breakthroughs is via the Hong Kong Genome Project, a government-led project to set up a genome sequencing database to help detect undiagnosed cancers.
“The objective is to look at the genomic sequencing of 50,000 Hong Kong citizens,” delineates CUHK’s Professor Dennis Lo. “By analysing this data, we may be able to arrive at a diagnosis of patients with previously undiagnosed diseases. We have just completed the pilot phase of this project, so we are doing ten percent of our target before we scale up. It is an exciting project using genomics on a large scale, with important implications for the future development of healthcare in Hong Kong and elsewhere.”
Dr Brian CHUNG Hon-Yin, chief scientific officer at the Hong Kong Genome Institute (HKGI) and clinical associate professor at the HKU lays out the rationale behind the project thusly. “Hong Kong has many researchers and universities that are doing a lot of excellent research in genetics and genomics, but the question should be about how to create a more concentrated effort to translate these important findings into clinical application. We have put in place some key steps to move in that direction.”
The industry understands the contribution of genetics and genomics for the success of their drug development, and this is why they are proactive in wanting to work with us
Brian CHUNG Hon-Yin, HKGI
“Firstly, a system with the correct infrastructure was put in place that shows what needs to be done to reach our targets, and so we set up an end-to-end servicing model within this Hong Kong Genome Project. End-to-end means assessing patients to see if they would benefit from gene sequencing, getting informed consent to store their DNA, analysing the data, and then giving feedback to these patients.”
“This is not a small-scale operation and requires collaboration between many players. To this end, we are working closely with patients, local authorities such as the Department of Health and Hospital Authority, medical schools and research teams of top-notch universities and hospitals, such as the Queen Mary Hospital, Prince of Wales Hospital, and Hong Kong Children’s Hospital, as well as CUHK and HKU. Furthermore, we are building the system by identifying personnel with an interest in genetic medicine, such as healthcare professionals, researchers, genetic counsellors and genome analysts, and including them in the project. Each of these members has a role to play.”
He maps out how the project could impact Hong Kong’s standing as a trials hub. “Clinical trials are costly. Many of them are stopped at Phase II and III and these drugs never reach the market. There have been studies to find a reason for the success or failure of a clinical trial, and one of the largest contributing factors is genetic data. The genome data of a patient contains around three million genetic variations, but a genetic mutation that creates a medical condition normally only represents one or two changes from this huge data set, meaning that finding these mutations can be very time-consuming work. The industry understands the contribution of genetics and genomics for the success of their drug development, and this is why they are proactive in wanting to work with us.”
Mainland China: Making the Connection
A final piece of the puzzle will be increased connectivity between Hong Kong and mainland China with its enormous population and healthcare market. Currently, clinical trials conducted in Hong Kong are not recognised by China’s regulatory body, the National Medical Products Administration (NMPA) in its decision-making process which caps their global relevance. Changing this is a governmental priority in Hong Kong, as Secretary for Innovation, Technology and Industry Dong SUN admits. “Clinical data generated in Hong Kong can be used and is recognised internationally, and we will continue to foster good practice and encourage even more clinical trials in the city,” he proclaims, “One of the most important next steps is to work with the government in mainland China to enable Hong Kong-generated data to be used for more regulatory approvals there, as it already is for bodies such as the US FDA.”
Some small steps in the direction of integration have already been taken, including the fact that certain hospitals in mainland Chinese GBA cities can now make use of therapies approved in Hong Kong but not by the NMPA. Pharma industry veteran Howard Lin, now founder and principal at his own industry-focused consultancy CL Consulting, feels that this alliance could be broadened to include clinical trials. “The GBA is an emerging pathway for therapies to become accessible to part of the mainland market, meaning those GBA-designated hospitals serving the nine mainland cities that comprise the GBA,” he states. “This could be a particularly attractive opportunity for companies whose therapies are yet to have Chinese patient data in clinical trials – a key requirement of the regulator in Beijing.”
For its part, HKU-CTC has prioritised closer integration with NMPA requirements to boost the applicability of Hong Kong clinical trials within China, including securing NMPA recognition for its teaching hospital, Queen Mary Hospital in 2006. The process of securing NMPA recognition for Hong Kong clinical trial data remains complex and fragmented although Yau highlights that the NMPA does exercise flexibility and accepts Hong Kong-generated data for some non-pivotal trials, thereby accelerating industry sponsors’ entry into the mainland market.
HKU-CTC has also moved to create a mainland China spinoff, leveraging the strengths developed over 25 years of operation with the burgeoning GBA ecosystem. “The spin-off serves as a platform for us to manage clinical trials not only in Hong Kong but also in the GBA, says Yau. “Our vision is to build a strong network of hospitals within the area, including institutions from Hong Kong, Shenzhen, Macau and others. By harmonizing quality standards, contractual requirements and workflows across this network, we aim to attract more sponsors and contract research organisations (CROs) to allocate their clinical trials to this region.”
We see the great potential of Hong Kong as a gateway to mainland China for the international markets and vice versa and we should leverage this position more, especially with respect to clinical trials
Vincent Tong, MSD
A more favourable regulatory environment with policies that promote increased collaborations across the GBA has the potential to significantly boost Hong Kong’s status as a clinical research hub, according to MSD managing director for Hong Kong and Macau, Vincent Tong.
Tong, who also serves as a member of the board of the Hong Kong Association of the Pharmaceutical Industry (HKAPI) and sponsors its ‘Partnering for Medical Advancement’ taskforce, asserts that “clinical trials are not just about investing money, but developing the ecosystem through regulations, the scientific community and making favourable policy changes that attract pharmaceutical companies to invest. Furthermore, we see the great potential of Hong Kong as a gateway to mainland China for the international markets and vice versa and we should leverage this position more, especially with respect to clinical trials.”
Leveraging the city’s already-strong datasets will be another crucial aspect. “The second area the task force is working on is obtaining quality data and using it responsibly,” adds Tong. “We have a population of over seven million, comparable to European countries like Sweden or Denmark. The Nordic Health Registries are world-famous for providing registry-based research in large populations with long-term follow-ups from birth to death. If they can use their data to attract clinical trials, we probably can too. The Hospital Authority holds a sizable patient database in Hong Kong, and it can offer great potential. If this data system can connect to the GBA and its ~86 million population in the future, our region will be even more appealing for research.”
