Hong Kong has grand plans to become one of Asia’s leading clinical trial hubs. Important regulatory upgrades and increased integration with mainland China via the Greater Bay Area initiative – including a new dedicated GBA Clinical Trial Institute at the Hong Kong/mainland border – mean that this is not just a pipe dream. However, as an illuminating panel discussion at last month’s BIOHK 2024 conference showed, several challenges still need to be ironed out to fully realise Hong Kong’s clinical trial hub potential.

 

Hosted by PharmaBoardroom CEO Diana Viola, the panel brought together Charlie Chen, chief operating officer of Hong Kong headquartered commercial-stage respiratory player Nuance Pharma; Dr Xia Jin, co-founder and CEO of another Hong Kong-based firm, clinical-stage vaccine developer Immuno Cure; Henry Yau, managing director of one of Hong Kong’s two Phase I clinical trial centres, the University of Hong Kong Clinical Trials Centre (HKU-CTC); and Professor Ping Feng of West China Hospital, a leading teaching hospital in Chengdu, Sichuan Province.

 

2023/24: Major Upgrades

Yau laid out some of the key developments in Hong Kong’s clinical trial ecosystem over the past year across four pillars: industry, study sites, government, and participants. On the industry side, he said that the immediate post-COVID period had been characterised by a downturn in investment, although this had started to rebound, driven both by local companies as well as Chinese firms.

In terms of study sites, in addition to the ongoing work at HKU-CTC and the Clinical Research Management Office at the Chinese University of Hong Kong (CUHK CRMO) Yau added that the Hong Kong Hospital Authority now required each of its seven hospital clusters to set up a cluster research office. This is paving the way for more public hospitals to host clinical research, a field in which historically their participation has been piecemeal. Private hospitals and clinics are also increasingly important players.

The Hong Kong government has made three major moves to shore up the city’s positioning as a trials hub. Most significantly, it has heeded calls from trial sponsors and laid out a roadmap to creating an independent regulatory body of its own, known as the Centre for Medical Product Registration (CMPR).

Secondly, as a step towards having a local FDA equivalent, Yau explained that the city has also implemented the ‘1+’ mechanism. Having previously required approvals from two separate regulatory authorities in other countries or regions (such as the FDA in the US, the EMA in Europe, or indeed the NMPA in mainland China), the new ‘1+’ mechanism allows for the approval of new drugs in Hong Kong if they have been approved in only one reference country. This is provided that they are supported by local clinical data and that there is a unmet medical need locally (the “+” part of the equation).

Thirdly, Yau noted that the Hong Kong government has made plans to establish the Greater Bay Area International Clinical Trial Institute (GBA CTI), a dedicated platform for conducting cross-border trials. Located in the very north of Hong Kong and hoping to bring in patients, clinicians, samples, and data from both mainland China and Hong Kong, the GBA CTI will also harmonise work across the existing 42 hospitals in Hong Kong. making them more suitable clinical trial locations.

 

Hong Kong or the Mainland?

But how do clinical trial sponsors in the region view Hong Kong and the Greater Bay Area? China, after all, already boasts three well-established clinical research hubs in Beijing – with proximity to China’s regulatory body the NMPA; Shanghai – with its long history of foreign and local biopharma industry investment; and Chengdu – home to the West China Hospital and a hotbed of clinical research expertise and experience.

“While our experiences with clinical research in Hong Kong are more formative than those in the mainland, I will say that Hong Kong has unique advantages in terms of start-up time, predictability, timelines, costs, quality, and interaction with international collaborators,” said Nuance Pharma’s Chen.

He added that greater regulatory integration with the GBA will only increase the city’s attractiveness, helping solve the previous issue of Hong Kong’s relatively small seven million population size (and consequently limited patient pool). The GBA in total has a population of over 86 million, equivalent to a large European country, and is therefore – in Chen’s eyes – “a vast opportunity to consider.”

For Immuno Cure, there are both pros and cons to choosing Hong Kong for clinical trials as it stands. “Through the experience of conducting trials in both Hong Kong and the mainland, we found that Hong Kong is good for small trials as you can obtain Department of Public Health approval very quickly,” explained Dr Jin. “However, the disadvantage is that the data will not be helpful for drug registration. In comparison, on the mainland, it is easier to do larger trials with a high level of efficiency and a larger patient base.”

Jin also pointed out that doctors on the mainland – unlike their Hong Kong counterparts – are incentivised to engage in clinical trials. They need to publish academic papers to gain promotion, while doctors in Hong Kong are often solely preoccupied with time-consuming – and more lucrative – clinical work. He added that Hong Kong lacks the teams of nurses with specific training for clinical trials that exist on the mainland, an issue that the city needs to rectify.

 

Greater Bay Area Integration

In attempting to position the Greater Bay Area as China’s fourth clinical trial hub, Yau opined that the region’s greatest strength – its diversity – is also its Achilles’ heel. “Our diversity is a big advantage,” he said. “We have a population of over 80 million, while Hong Kong and Macau serve as portals to the rest of the world. However, at the same time, we have three separate legal systems in Hong Kong, Macau, and mainland China, which adds a great deal of complexity.” He added that the Hong Kong government was working hand-in-hand with its counterparts in Shenzhen on several related projects, notably the GBA CTI, with counterpart institutions being established on both sides of the border.

Nuance’s Chen highlighted the potential of eventually holding cross-border GBA-wide clinical trials, both from a commercial perspective in terms of having early access to the patient, as well as enriching the breadth of programs on the development front. “One example is early access programs. When you have a product approved in Macau or Hong Kong, how do you get that into the Greater Bay Area? Already, we have seen a lot of positive tailwinds in terms of expansion from 10 mainland hospitals to 19, and we have heard that it is further expanding.”

The GBA CTI could also be crucial to breaking down two major current barriers to mainland-Hong Kong clinical trials: the freer flow of biological samples and of patient data. Dr Jin relayed an anecdote about how his firm had been an early mover on cross-border COVID-19 vaccine clinical trials back in March 2020. However, during the drawn-out and delayed process of transferring samples between Hong Kong and the mainland, competitors based elsewhere caught up and gained approval for their own vaccines, forcing Immuno Cure to abandon the project. Yau suggested that central laboratories at GBA CTI could circumvent this problem in the future and host both samples and data from both sides of the border.

Chen also had a word of caution for the Hong Kong government. “To be frank, we need to see some concrete steps and clear guidelines on how sponsors can leverage the GBA policy.” He also called for greater incentives – whether financial or regulatory – for companies to invest in high-potential but incredibly complex multi-site trials across the GBA. Likewise, Jin advised that funding and maintenance of the region’s clinical trial network cannot be left to private actors alone, calling for greater government spending on its running costs.

 

To read more about the healthcare and life science ecosystem in Hong Kong and the Greater Bay Area, download our latest report on the region here.

 

Image Source: BIOHK