Hong Kong’s unique history as a former British governate and current special status under the ‘one country, two systems’ administrative framework, endow it with many underlying advantages as a ‘talent magnet.’ From a professional standpoint, the city’s international connectivity, financial architecture, and efficient infrastructure already render it an appealing location for young entrepreneurs, not to mention additional benefits such as unrestricted currency exchange, seamless capital movement, and visa-free entry for US passport holders.
Little wonder then that the region has fast become a favoured destination for repatriated Chinese scientific talent – colloquially known as ‘sea turtles,’ – many of whom have been Western educated and cut their teeth abroad with Big Pharma before returning home armed with global best practices, expert knowledge and experience.
“In direct contrast to alternative jurisdictions, such as the Chinese mainland where access to information, and even materials, may be subject to heavy bureaucratic constraints, Hong Kong’s cosmopolitan openness facilitates the sort of collaborative and dynamic ecosystem in which top-class, internationally trained Chinese researchers and scientists are likely to feel at home and thrive,” says Dr Hua Zhang, vice president and chief scientific officer at SPH Biotherapeutics, a research affiliate of Shanghai Pharma focused upon advancing a dual-targeting CAR-T platform for paediatric leukaemia.
The success of InnoHK and the University of Hong Kong in recruiting talent for a new Centre for Translational Stem Cell Biology (CTSCB) serves as an illustrative example. “In under four years, we managed to assemble a world-class team of around 100 young cell and gene researchers, predominantly in their twenties and thirties. Many of these scientists are bringing valuable international experience from global biopharma and have already made important contributions to the field, having been involved with numerous patent filings,” enthuses Professor Pengtao Liu, the centre’s managing director.
Clearly Defined Pathways
Meanwhile, with the city striving to punch above its weight in positioning itself as a strategic base for biomedical innovation, Hong Kong’s administrators have been studiously fashioning an enabling environment consciously geared towards attracting biotechs active in pioneering next-generation life sciences.
“Certainly, the local administration has been taking proactive steps to build a more integrated life sciences landscape that spans discovery through to clinical translation,” affirms Professor Zongli Zheng, co-founder and chair of GenEditBio, a technology platform company and developer of next-generation therapeutics. “Recent efforts to streamline regulatory protocols signal a clear intention to strengthen the city’s role as a fully-fledged biopharmaceutical innovation centre with in-house capabilities spanning the entire value chain,” he thinks.
Indeed, as far back as fall 2021, the regional government formally rolled out a dedicated regulatory regime for advance therapeutic products (ATPs) – covering everything from gene therapies and somatic cell treatments to tissue engineered products – and subsequently awarded local licences to both private and public entities for the manufacturing ‘living’ drug technologies as well.
“In October 2023, our company was granted the Special Administrative Region ‘s first-ever commercial manufacturing license for clinical-grade advanced therapy products, which involved genetically modifying immune cells from patients to identify and destroy cancer cells,” proudly recalls Dr Camie Chan, chief executive officer at Xellera Therapeutics. According to her, this represented a ‘Rubicon moment’ for the city’s prospects as a biomedical pioneer, as having manufacturing capabilities close at hand massively multiplied the opportunities for cutting-edge cell and gene research.
Then, more recently, the region’s policymakers implemented the so-called ‘1+ mechanism’ for speeding up the registration of new drugs used for the treatment of life-threatening or severely debilitating diseases. Under this procedure, new biological entities and ATPs that are supported by local clinical data can be applied for registration by submitting approval from only one reference drug regulatory authority (instead of two as had previously been required).
Some market insiders are anticipating yet more exciting developments to come. “Under the current registration model, new therapies must first receive approval in another jurisdiction before becoming eligible for registration in Hong Kong, still creating a barrier for local innovation. We eventually envisage a domestic regulatory pathway that would allow clinical-stage products developed within Hong Kong to seek first registration locally, thereby streamlining translational research and encouraging academic and biotech-driven development,” predicts Dr Gina Jiang, managing director of the Institute of Biotechnology (HKIB).
Regulatory Stringency
Interestingly, Hong Kong’s regulatory system for advanced therapies remains comparatively more stringent than most Far East Asian jurisdictions. “All ATPs, whether for clinical trials or commercial use, must be manufactured in licensed GMP facilities, with no exemptions permitted, even at early development phases,” details Xcellera’s Camie Chan.
This differs markedly from regimes like Japan, which pursues a dual-track approach that allows hospital-based applications without full commercial authorisation, or the Chinese mainland, which deploys a flexible process in which the National Medical Products Administration (NMPA) governs formal IND pathways, while a lighter-touch National Health Commission (NHC) is left to oversee hospital-based Investigator-Initiated Trials.
“Such a rigorous compliance environment can, of course, prove challenging for early-stage biotech companies, especially those entering Phase I trials where full commercial-level GMP adherence may not yet be financially feasible,” she concedes, noting that the region might significantly benefit from adopting more adaptive and expedited clinical approval pathways.
“For instance, conditional approvals for innovative CGTs based on a plausible scientific mechanism, rather than traditional randomised controlled trials, could be considered, which would facilitate quicker progression from early-phase trials to clinical application, benefiting both patients and innovators alike,” she proposes.
Nonetheless, by insisting upon a higher bar for compliance, Hong Kong certainly ensures exceptional quality assurance. “Although the region entered this field later than many regional counterparts, the specific regulatory framework it has adopted serves as a powerful quality signal to the market,” believes Chan, placing it more akin to a gold-standard.
“The end consequence is actually a robust and credible basis for clinical-grade manufacturing, and for companies like Xellera, this regulatory clarity massively strengthens our reputation internationally as a reliable and trusted CDMO partner,” she concedes.
Big-Ticket Financing
“Concurrently, the government has introduced a sophisticated apparatus of support for early-stage companies developing cell and gene therapies – combining targeted financing schemes with structured incubation programmes explicitly designed to guide biotech ventures from inception through to clinical maturity,” observes Professor Zongli Zheng, co-founder and chair of GenEditBio, a technology platform company and developer of advanced therapeutic products.
“Initiatives such as the MedTech Co-Create Programme, along with co-investment schemes involving the Hong Kong Science and Technology Parks (HKSTP) Corporation and the Innovation and Technology Venture Fund (ITVF), have provided meaningful momentum for companies like us while simultaneously fostering a strong culture of translational research,” he reveals.
Dr Linxian Li, founder and CEO of InnoRNA, a platform-based company specialising in the R&D of delivery platforms for nucleic acid therapeutics reports similar experiences. “We found the region to be highly supportive during our early development. To begin with, the HKSTP offered infrastructure and funding support with one of our clinical trials partially funded through these mechanisms,” he recalls.
In parallel, the Innovation & Technology Commission (ITC), an agency tasked with advancing research and innovation across academic and industry sectors, provided matched funding enabling her company to pursue ambitious research and development goals without being solely dependent on private capital. “Compared with mainland China, where state grants typically come post-trial and are tied to domestically conducted studies, this makes a massive difference for globally oriented companies such as ours,” he confides.
Another big beneficiary of ITC grants has been the Advanced Therapy Product Good Manufacturing Practice Centre (ATP GMP Centre) at the Chinese University of Hong Kong’s (CUHK) Institute of Biotechnology (HKIB), the first university-led centre to conduct cell and gene manufacturing within the Chinese entrepôt.
“Such financing was instrumental to enabling the launch of a clinical trial that will treat up to 20 patients with locally produced CAR-T therapy, an important step toward building a sustainable and sovereign model for advanced therapeutics in the region,” says Professor Chi Kong Li, research professor of the Department of Paediatrics within CUHK.
“Establishing and maintaining such a system comes at a significant financial cost. Unlike conventional trials, CAR-T studies demand constant environmental control, single-use consumables, and highly skilled personnel, all of which place great pressure on operational budgets, so having recourse to public revenue streams like that can make all the difference,” he explains.
Dr Gina Jiang of the HKIB very much agrees. “The existence of a stable funding framework not only ensures operational continuity but also serves as a signal of credibility to international partners and investors evaluating Hong Kong as a base for long-term engagement. In this respect, consistent public investment is not simply a financial mechanism, it represents a significant competitive advantage and a strategic tool for securing the city’s future in global life sciences,” she opines.
State Mobilization
Such efforts have also been complemented by the work of the Office for Attracting Strategic Enterprises (OASES), a Hong Kong government initiative specially designed to attract foreign direct investment in forward-looking industries deemed vital to cementing the city’s role as an international innovation and technology hub.
The office has been empowered to formulate attractive special facilitation measures covering aspects such as land, tax and financing that are applicable exclusively to target enterprises, while also providing the employees of those enterprises with one-stop facilitation services in areas such as visa application.
To date, one of its crowning achievements has been to elicit the participation of Anglo-Swedish biopharma, AstraZeneca, which has committed to constructing a 100 employee-strong R&D centre devoted to developing cell and gene therapy within Hong Kong’s Lok Ma Chau Loop technology hub. “The contribution of OASES is testament to the regional government’s dedication to having a collaborative and constructive partnership approach,” notes Shaun Grady, the company’s senior vice-president for business development operations.
“Two fundamental aspects convinced us that the time was ripe for this sort of move. Firstly, the administration’s clear focus and supportive policies on medical research and development, and secondly, the wider commitment to building a stronger ecosystem, meaning that the overall push for transformative change will be a genuinely collective effort. After all, the path to developing cell and gene therapies cannot be walked alone,” he affirms.
Iconic Swiss drug developer, Ferring Pharmaceuticals, is another big brand that has been contemplating closer interaction with Hong Kong’s fledgling ATP ecosystem. The company has already taken the step of introducing its novel gene therapy Adstiladrin for patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, and its general manager, Lawrence Wong, confides that the local affiliate is constantly evaluating fresh opportunities to capitalise upon the region’s growing credentials as a biomedical hub.
“In my opinion, Hong Kong, thanks to an impressively systematic and coordinated response, now exhibits many of the characteristics needed to be a relevant player in this field: a supportive policy environment, world-class standards of clinical management, and a comprehensive health system alongside a growing prowess in academic and research excellence,” he concludes.
