Since we last covered Hong Kong in Summer 2023, the territory’s regulatory landscape has taken a major step towards its long-term goal of establishing a full regulatory authority. 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 local unmet medical need (the “+” part of the equation).
As Secretary for Health Professor Lo Chung-mau explains, “The transition from secondary to primary evaluation is the ultimate goal of our regulatory authority, the Center for Medical Products Regulation (CMPR). The ‘1+’ mechanism is a critical intermediary step in this process as it provides a much faster route for new drug registration by eliminating the delays typically associated with attaining a second certificate of pharmaceutical product.”
A preparatory office for the CMPR has now been established, with a roadmap in place to conduct independent abridged reviews by 2026, become a member of the International Council for Harmonisation (ICH) by 2027, conduct full reviews by 2030, and be fully ICH-compliant by 2032.
Professor Lo adds that “This streamlined approval process accelerates the registration of innovative drugs and devices from both the Western world and Mainland China, where the biomedical industry is advancing rapidly. The ‘1+’ mechanism allows us to build the necessary expertise and talent pool, preparing us for primary evaluation.”
Understandably, there is a frisson of cautious optimism about this update among the representatives of innovation-driven global pharma implanted in Hong Kong. Many of them foresee ‘1+’ leading to broader and more rapid access to their most cutting-edge products in Hong Kong, and potentially across participating hospitals in the Greater Bay Area (GBA) as well.
“These regulatory reforms are part of Hong Kong’s strategic plan to improve patient access to innovative medical products and strengthen its position as a hub for pharmaceutical and medical device development in the region,” says Sabrina Chan, who represents these companies as senior executive director of the Hong Kong Association of the Pharmaceutical Industry (HKAPI).
“’1+’ offers a more streamlined pathway for drug registration, which is beneficial for both pharmaceutical companies and patients alike,” adds Yuko Mizuma, GM for Hong Kong & Macau at US-headquartered giant Eli Lilly which is active across diabetes, oncology, immunology, neurodegeneration and pain.
However, as HKAPI’s Chan warns, Hong Kong would do well to keep its regulatory options open as few companies will choose to file primary reviews in what is a relatively small market. “We need to retain the secondary review route,” she says. “Flexibility in the regulatory framework is paramount and we should take lessons from the multi-route approach being used in markets like Singapore. It is crucial that any changes do not inadvertently prolong the review process, as competitiveness with other markets is key. Ultimately, we need to ask: Why should companies choose to register their products in Hong Kong earlier?”
Swiss behemoth Novartis, for its part, is already leveraging the ‘1+’ pathway, despite it only being enacted in November 2023. Head of Novartis Hong Kong Derek Chang notes that “one of our compounds for a haematological rare disease has already progressed through the ‘1+’ track, marking our pioneering involvement in this streamlined approval process.” He continues, “It was a pleasure to learn that this new drug met the standards of safety, efficacy and quality and received approval in Hong Kong in July, only seven months after being greenlit by the US FDA.”
Others are adopting more of a “wait-and-see” approach, having not yet been able to benefit from this new pathway. Fellow Swiss firm Ferring, for example, is not yet utilising ‘1+’ for its portfolio of advanced therapy products (ATPs). “Currently, the ‘1+’ mechanism mainly addresses new chemical entities (NCEs), while ATPs are not yet considered under this framework,” explains GM Lawrence Wong.
J&J Innovative Medicine GM Sunkeun Huh is also optimistic but cautious on the potential impact of ‘1+.’ “We are currently still evaluating how to leverage this new policy to enhance our opportunities,” says Huh. “Although initially, the impact might seem limited due to our simultaneous filings with other regulatory bodies like the US FDA and EMA, we are actively exploring how to maximise this policy for future assets.”
However, Huh does point out that “If the policy effectively accelerates both regulatory approval and market access, it could significantly strengthen Hong Kong’s position as a hub for innovative medicines.”
More rapid approvals in Hong Kong could also foster opportunities to roll out medicines across the 19 public hospitals in the GBA able to use Hong Kong-registered drugs and medical devices used even if they are not yet registered with mainland China’s National Medical Products Administration (NMPA). “The regulatory processes in mainland China are quite robust and stringent, and usually involve clinical trials to ensure product safety and efficacy,” explains Ferring’s Wong. “In contrast, products already approved elsewhere can possibly be fast-tracked [into mainland China] through the Hong Kong pathway.”
Roche’s Liu is also looking beyond Hong Kong’s borders and foreseeing an enhanced regional role for her affiliate. “Approval speed is crucial because it allows us to lead and become a world-leading innovation hub, not just in Asia but globally,” she opines. “Faster product approval in Hong Kong extends the window of opportunity in the GBA. With mainland China’s approval times becoming faster, Hong Kong’s willingness to change and expedite approvals can significantly enhance our impact on the GBA.”
Over at Japanese neuroscience player Eisai, GM Andrea Chang sees this refreshed regulatory landscape leading to a wider portfolio for the Hong Kong affiliate, as well as more clinical trials in the city. “With the implementation of the ‘1+’ system, there is a potential for us to expand our product portfolio through business development initiatives,” says Chang. “Leveraging our strong collaboration with Eisai’s extensive team in China, we can explore acquiring new products to introduce into Hong Kong.”
The opportunities that the 1+ pathway creates are, therefore, multitudinous – especially for global pharma companies looking to penetrate the Hong Kong and China markets. However, the Hong Kong authorities need to keep a flexible approach, ensuring that multiple regulatory pathways are open to industry sponsors, to maintain the market’s attractiveness to innovators.
