Amgen’s trajectory in Hong Kong reflects a broader shift underway across the territory’s healthcare landscape, where data-driven care and cross-sector collaboration are converging to accelerate access to innovation. Against the backdrop of rapid demographic change and rising chronic disease burden, Kara Cheung outlines how the company is evolving its portfolio, strengthening clinical integration, and contributing to Hong Kong’s position as an international health and medical innovation hub. The result is a model that balances innovation with system sustainability, while increasingly anchoring Hong Kong within Asia’s next phase of healthcare development.
What has shaped your journey at Amgen Hong Kong, and how has the organisation evolved since you joined?
I serve as general manager of Amgen Hong Kong, with responsibility for both Hong Kong and Macau, and joined the organisation in December 2018, around two years after our local presence was established. At that point, we were still in the early stages of building our local presence, with a team of roughly 20 people. Since then, we have scaled our presence, reflecting both stronger execution and a more established footprint in the market in order to better serve patients by meeting their needs through innovative science and biotechnology.
That growth has been closely tied to the evolution of our portfolio. When I arrived, we were still managing a number of legacy products from a period when Amgen did not have a direct presence in Hong Kong. Over time, we have shifted towards a more innovation-led portfolio, with new product launches expected by the end of this year, which has allowed us to better align with patient needs and the broader direction of the healthcare system.
Although we entered the market later than many of our peers, it has proved to be a well-timed step in strengthening our local presence. The Hong Kong government has set out plans to position the city as an international clinical and innovation hub, and that has created a supportive environment for multinational companies bringing new therapies into the market. The introduction of the “1+” mechanism in late 2023 has introduced a new pathway in this regard, allowing registration based on a single reference authority with a target review timeline of around 150 working days. This has introduced a more structured process with defined timelines, and it’s great to see increased activity in submissions and approvals, supporting more timely access to new therapies.
How has government engagement and regional integration shaped Amgen’s clinical and innovation strategy in Hong Kong?
The shift was largely catalysed by proactive government engagement. In 2023, Professor Lo Chung-mau, Secretary for Health, together with Dr Ronald Lam, Director of Health, initiated dialogue with pharmaceutical companies to set out Hong Kong’s ambition to further strengthen its clinical and innovation ecosystem. That exchange was important because it signalled a clear willingness to work closely with industry, particularly in areas such as clinical trials, real-world evidence, and the management of non-communicable diseases associated with an ageing population, reinforcing Hong Kong’s strategic relevance within the region.
That initial dialogue developed into more structured collaboration and we started engaging with the Greater Bay Area International Clinical Trial Institute (GBAICTI), a government-backed platform designed to strengthen Hong Kong’s clinical research capabilities while linking them more closely to the wider GBA. These discussions brought together government, academia, healthcare providers, and industry, and marked a step towards exploring longer-term collaboration across clinical development, real-world evidence, and cross-border initiatives.
A key factor underpinning this ambition is the strength of Hong Kong’s research infrastructure. The Hospital Authority operates a centralised clinical management system that integrates data across the public healthcare system and captures millions of anonymised longitudinal patient records, providing a strong foundation for real-world evidence and population-level research. Combined with well-established academic institutions and recognised clinical trial capabilities, this creates a compelling environment for advancing research, supporting earlier diagnosis, and generating insights that can inform both local care and broader regional strategies.
Hong Kong has been part of Amgen’s clinical development footprint since 2007, well before the establishment of our commercial presence, and continues to play a meaningful role in our global pipeline. At the same time, we are rethinking how clinical trials are conducted, integrating real-world data, digital technologies, and more adaptive study designs to improve efficiency and better reflect real patient populations. The objective is to support more efficient clinical development, helping to bring new therapies to patients in a more timely way.
How do you assess the evolution of Hong Kong’s regulatory framework, from the “1+” mechanism to the planned introduction of primary drug evaluation?
The “1+” mechanism represents a meaningful step forward in Hong Kong’s regulatory development, but it is best seen as part of a broader transition rather than a final model. By allowing medicines to be registered based on approval from a single reference authority, it has introduced a more structured pathway with defined timelines. This means new, innovative medicines can get to patients even faster.
In parallel, the government is progressing towards primary evaluation, under which Hong Kong would independently assess medicines based on full clinical and pre-clinical data, with phased implementation from 2026 and the ambition of establishing a fully independent regulatory authority by 2030. Taken together, these developments reflect broader efforts to further develop Hong Kong’s regulatory capabilities over time.
At a more fundamental level, this direction aligns with the shared objective across healthcare systems globally, which is to ensure timely patient access to new therapies while maintaining high standards of safety, efficacy, and quality. A regulatory framework that balances access and safety is important to support both innovation and patient care, and in our experience, the Department of Health has taken a collaborative and pragmatic approach as the “1+” pathway has been introduced. There has been active engagement with industry to clarify submission requirements and guide companies through the process, while the defined review timeline of around 150 working days, supported by a stop-clock mechanism, has made the pathway more structured and predictable.
From a broader industry perspective, including through my role as vice president of the Hong Kong Association of the Pharmaceutical Industry, there is a strong case for maintaining flexibility as the system evolves. The “1+” mechanism and primary evaluation serve different but complementary purposes, and preserving both pathways helps ensure patients can access a broad range of innovative therapies. If the ambition is to establish Hong Kong as an international innovation hub, offering multiple regulatory routes will be important to sustain both competitiveness and access.
Against the backdrop of an ageing population and rising chronic disease burden, where are you focusing your portfolio to address Hong Kong’s most pressing healthcare needs?
Hong Kong’s demographic trajectory is a defining factor in how we approach our portfolio. The population is ageing at pace, with those aged 65 and above projected to rise from around 20 percent in 2021 to 36 percent by 2046, alongside one of the highest life expectancies globally. This shift is already translating into a higher burden of chronic disease and increasing pressure on the healthcare system, which means that addressing these challenges requires coordinated action across government, clinicians, researchers, industry, and patient organisations to ensure long-term sustainability.
At the same time, Hong Kong benefits from a uniquely strong data infrastructure. The Hospital Authority’s centralised clinical management system captures large-scale, longitudinal patient data across the public system, creating a robust foundation for real-world evidence and population-level research. This allows for closer collaboration across the ecosystem, combining clinical insight, data, and emerging technologies to support earlier diagnosis and more personalised care. The government has also placed increasing emphasis on prevention, notably through the Primary Healthcare Blueprint, which promotes early detection and community-based care in response to the heavy reliance on the public healthcare system.
Within this context, cardiovascular disease and bone health remain key priorities. Cardiovascular disease is the third leading cause of death in Hong Kong, and more than half of adults have elevated cholesterol levels, yet follow-up and long-term management remain inconsistent. Many patients do not achieve recommended treatment targets after major events, increasing the risk of recurrence. Addressing this gap requires a more integrated approach, ensuring that patients already on treatment are managed appropriately over time while also identifying and treating those at risk earlier, which reinforces the importance of continued collaboration with the healthcare system.
What role do cross-sector partnerships, particularly in areas such as prevention and real-world evidence, play in improving patient outcomes in Hong Kong?
Collaboration underpins our approach in Hong Kong, both in how we generate evidence and how we engage with patients and the wider healthcare system. One example is our partnership with the University of Hong Kong on an AI-enabled cardiovascular risk prediction tool developed specifically for the Chinese population in Hong Kong. By drawing on real-world data from the Hospital Authority, it supports earlier identification of high-risk patients and enables more personalised prevention strategies, helping to close gaps in risk assessment and continuity of care.
At the same time, we place strong emphasis on patient education and community-based initiatives. We work closely with District Health Centres, which serve as primary care hubs, to support early screening and awareness, particularly in areas such as osteoporosis where timely intervention can prevent fractures and reduce long-term burden. This includes both public education and targeted training for general practitioners to strengthen early identification and diagnosis.
In cardiovascular care, our efforts extend into post-event management, where we collaborate with hospitals and nurses to support secondary prevention, including adherence, lifestyle changes, and risk factor control. These programmes are complemented by partnerships with patient advocacy groups, which play an important role in awareness, rehabilitation, and long-term disease management. Together, these initiatives aim to improve patient understanding, reinforce continuity of care, and reduce the risk of recurrent events.
How do you view Hong Kong’s healthcare funding dynamics, and how does Amgen adapt its portfolio to balance innovation with affordability?
Similar to healthcare systems around the world, Hong Kong’s healthcare system operates within clear financial constraints, and the government is working to strike a balance between expanding access to innovative therapies and maintaining long-term sustainability, particularly in the context of an ageing population and a growing burden of chronic disease. This has led to a gradual recalibration between the public and private sectors, with increasing encouragement for those who can afford it, often through medical or voluntary insurance, to seek care in the private system, thereby easing pressure on the public sector, which continues to serve the majority of patients.
Within this environment, maintaining a balanced portfolio becomes essential. Amgen remains committed to developing innovative medicines that target serious diseases with high unmet needs. We believe that innovative medicines create value for both patients and for society by reducing disease burden. In tandem, we recognise the importance of ensuring access across a range of treatment options. Biosimilars form an important part of this approach, and we currently have three on the market in Hong Kong, with additional launches planned, supporting a more sustainable model of care.
Biosimilars are generally well accepted within the public hospital system, which allows the Hospital Authority to expand access while freeing up resources to fund newer therapies. At the same time, clinician confidence has continued to strengthen, supported by consistent product quality and reliable supply. Our long-standing experience and track record in biologics manufacturing, combined with stable supply, has been an important factor in building that trust and supporting broader adoption.
What are the key priorities for Amgen Hong Kong in the coming years, and how can the affiliate contribute to the broader Asia Pacific organisation?
Looking ahead, our focus is on continuing to expand the portfolio while ensuring that what we bring remains relevant to the needs of the Hong Kong population. Rare diseases represent an important next step for us, both globally and locally, although they require a more considered approach given the small patient populations and the need to work closely with the government on access and reimbursement. At the same time, we remain committed to our core therapeutic areas, particularly cardiovascular disease, oncology and bone health, where the level of unmet need remains high and sustained focus continues to be necessary.
Managing this balance is critical. While we have a strong pipeline and a number of innovative therapies coming forward, we need to be selective in how we prioritise and sequence launches in a relatively small market. This requires a clear understanding of local epidemiology, healthcare priorities, and access dynamics, ensuring that we focus on areas where we can deliver meaningful impact while gradually building capabilities in newer segments such as rare diseases.
From a regional perspective, Hong Kong offers a number of practical insights that can be shared across Asia Pacific. The coexistence of a highly utilised public system and a well-established private market provides a useful model for engaging different payer segments and expanding access beyond public reimbursement, which remains a relevant consideration for many markets in the region.
In parallel, Hong Kong’s clinical research environment remains a distinct strength. The presence of leading academic institutions, experienced investigators, and access to large-scale patient data creates a strong foundation for generating insights relevant to Asian populations. Combined with the proximity of the Greater Bay Area, this creates opportunities to support broader clinical development and future regulatory strategies, reinforcing Hong Kong’s role as both a local market and a regional contributor, and transforming the promise of science and biotechnology into medicines that restore health or save lives.
