Background
A decade ago, during my time as a biomedical engineering student at Imperial College London, Hong Kong’s strategic priorities were largely centered on finance and real estate development, with comparatively limited emphasis on innovation and technology-driven growth. In recent years, however, fostering innovation and technology has become one of Hong Kong’s key priorities. In my view, Hong Kong has strong potential to develop into one of the leading biotech hubs by leveraging its strategic position within the Greater Bay Area (“GBA”), its role as an international financial centre and its well-established, internationally respected legal system.
A key development strategy for Hong Kong is South-North dual engine (「南金融、北創科」), with the financial services continuing to develop at the Harbour Metropolis, whereas the new engine for innovation and technology will be positioned at the Northern Metropolis. The Hong Kong government is committed to accelerate the development of the Northern Metropolis which includes, among others, building new railway lines to improve connectivity to and from the area, developing the San Tin Technopole, and engaging major corporations—such as pharmaceutical companies—to establish a presence in the Northern Metropolis. The Northern Metropolis is built to attract global talents and enterprises while also cultivating local talent for the future.
What is Biotech?
“Biotech” is an abbreviation of biotechnology, meaning the manipulation of biological process, systems or living organisms to develop products that can improve human lives. However, the term “biotech” is often used to denote more than merely biotechnology but represents a much broader concept – biomedical engineering, a broad discipline that apply interdisciplinary engineering principles to improve health and function of patients through developing diagnostic, therapeutic and rehabilitative products.
Highly cross-discipline in nature
Biomedical engineering is a highly interdisciplinary and heavily regulated industry with a long, complex development pipeline that extends well beyond laboratory research. Companies must navigate scientific challenges, clinical trials, patent protection, regulatory approvals, and sustained fundraising, often operating for years without revenue. Due to high risks and low success rates, professional investors remain cautious by conducting rigorous due diligence and limiting their investment to those areas where they possess technical expertise.
Legal professionals’ roles
Legal professionals are integral to biotech companies at many stages of their development, providing guidance on intellectual property protection, regulatory and approval matters, commercial transactions, corporate structuring, capital raising, IPOs, M&A, and dispute resolution. In light of the sector’s scientific complexity, stringent regulatory environment, lengthy development cycles, and significant investment risks, lawyers play a crucial role in mitigating legal exposure while facilitating strategic expansion and successful commercialisation.
Chapter 18A of the HKEX Main Board Listing Rules
Chapter 18A of the HKEX Main Board Listing Rules sets out alternative set of listing requirements for biotech companies, waiving the traditional minimum revenue requirement. Since the introduction of Chapter 18A in 2018, pre-revenue biotech companies have been able to list in Hong Kong, subject to the satisfaction of all the relevant rules or wavier of such requirements. According to the website of the HKEX, 80 companies have listed via Chapter 18A as of end-November 2025. The significance of Chapter 18A is to provide another method for the biotech companies to raise fund besides governmental grant, private equity sale and debt. Most importantly, the Chapter 18A listing route is friendly to pre-revenue biotech companies.
It is noted that “biotech” is defined broadly under Chapter 18A to allow a wide range of biomedical engineering enterprises to be listed in Hong Kong. It is set out in paragraphs 3.3 and 3.4 of the Guidance Letter (HKEX-GL92-18) and Chapter 18A that the HKEX will consider the listing application of a biotech company which sufficiently demonstrate it has developed a biotech product beyond concept stage and such biotech product must fall within one of the four categories: (1) Pharmaceutical (small molecule drugs), (2) Biologics, (3) Medical devices (including diagnostics) and (4) “Other Biotech Products” at the discretion of the HKEX. For more information, please refer to Chapter 18A of the HKEX Main Board Listing Rules and Guidance Letter (HKEX-GL92-18) and seek professional advice.
Medical Data Sharing
Data plays a critical role in the development of biotech industry. The success of biotech products largely depends on clinical trial results, which are basically large-scale statistical analysis on safety and efficacy. Early access to extensive data helps researchers better predict outcomes, allocate resources more effectively, and avoid costly late-stage failures.
In Hong Kong, initiatives such as the Hospital Authority’s Data Sharing Portal provide clinical data from over 40 public hospitals for academic research, subject to approval and strict privacy safeguards.The Hong Kong government also launched the Electronic Health Record Sharing System (eHealth) in 2016, a consent-based platform enabling secure sharing of encrypted patient records between authorized public and private healthcare providers. On 24 December 2025, the Health Bureau expanded the “Cross-boundary Health Record” function of the eHealth app to all approximately 6.3 million users, allowing eligible records to be shared with designated medical institutions in mainland China and enabling cross-border deposit and access of medical records for follow-up care.
The above demonstrates that the Hong Kong government is actively promoting the digitalisation of medical records, which could play a crucial role in advancing the R&D of biotech products. In Hong Kong, the collection, handling and use of personal data is subject to the Personal Data (Privacy) Ordinance (Cap. 486).
The Hong Kong Centre for the Medical Products Regulation (“CMPR”)
On 26 June 2025, the Department of Health announced that the CMPR will be established by the end of 2026 and that the Department of Health will implement primary evaluation for new drug registration in phrases starting from 2026, with full implementation by 2030. The vision of the CMPR is to become a "leading, internationally renowned medical products regulatory authority” which promotes innovation, and R&D of drugs and devices by optimising medical products regulation.
Primary evaluation will be implemented in phrases in the period from between 2026 to 2030 with the scope expanding each year:
- Phase 1 (2026 onwards): products containing registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage form);
- Phase 2: products containing registered biological entities with extended applications;
- Phase 3: new drugs containing certain non-first-in-class entitles, and certain advanced therapy products; and
- Phase 4 (by 2030): full implementation of the primary evaluation covering all kinds of pharmaceutical products.
The importance of the CMPR is to establish a local regulatory authority in Hong Kong to complete a comprehensive life-cycle of medical products – R&D, funding, regulatory approval, commercialisation across Hong Kong and the GBA.
Conclusion:
Biotech is a high-risk, capital-intensive industry, but successful biotech products can deliver significant health benefits, strong patent-protected profits, and wide-ranging economic gains through job creation across the value chain. Hong Kong's robust financial and legal systems, combined with its strategic location in the GBA, position it perfectly to become a world-class biotech hub. Hong Kong legal professionals will play increasingly important roles in supporting biotech companies throughout their entire lifecycle, and backing Hong Kong to become a leading hub for capital market, regulation and dispute resolution for the biotech industry.
Disclaimer: This material is provided for general information only. It does not constitute legal or other professional advice nor constitute any lawyer-client relationship between Sit, Fung, Kwong & Shum and any user or browser. No liabilities are assumed arising from any reliance of information in this material.
