Three More New Drugs Approved Under Hong Kong’s 1+ Drug Approval Pathway—Total Reaches 19

Hong Kong’s drug registration landscape is moving faster. Authorities have approved three additional new drugs under the city’s “1+” drug approval mechanism, bringing the total number of approvals under this pathway to 19. The newly approved products target type 2 diabetes, chronic obstructive pulmonary disease (COPD), and unresectable or metastatic non-small cell lung cancer (NSCLC)—offering patients more treatment choices across chronic disease management and oncology.

What is the “1+” drug approval mechanism?

What is the 1+ drug approval mechanism?

The “1+” mechanism is designed to speed up registration of new drugs in Hong Kong, especially those addressing serious or rare diseases.

• Launched: 1 November 2023

• Expanded: 1 November 2024 to cover all new drugs, including:

  • products with new chemical entities or biological ingredients

  • new indications for existing drugs

  • vaccines

  • advanced therapy products (e.g., certain cell and gene therapies, depending on classification)

In simple terms, if a company can provide qualifying local clinical data and receive endorsement from local experts, it can apply for Hong Kong registration by submitting registration proof from just one reference drug regulator—hence the idea of “1+”.

The latest approvals: where were they first authorized?

Of the three newly approved drugs:

• The type 2 diabetes drug had been approved by China’s National Medical Products Administration (NMPA).

• The COPD and NSCLC drugs had been approved by a U.S. drug regulatory authority.

All three then used the “1+” mechanism to apply for registration in Hong Kong.

Progress so far: 19 approvals, with uptake in public hospitals

Since the “1+” mechanism took effect, Hong Kong has now approved 19 new drugs through this pathway. Importantly, seven of these have already been included in the Hospital Authority Drug Formulary, which is a key step toward broader access within the public healthcare system.

Strong industry interest—and more advanced therapies in the pipeline

The Department of Health has been actively promoting the “1+” mechanism. Interest from industry has been significant:

• nearly 200 pharmaceutical companies have made

• over 770 enquiries, including firms from overseas and mainland China

Many companies have also indicated interest in using the expanded “1+” mechanism to submit registration applications for advanced therapy products, reflecting a shift toward next-generation treatments.

Making the pathway easier to use: consultation and workshops

To improve clarity and efficiency, the Department of Health has rolled out supporting services, including:

• a pre-submission consultation service for “1+” applications

• multiple briefing sessions and drug registration workshops (starting last March)

• pre-application meeting consultations introduced in December, aimed at improving processing efficiency and reducing avoidable back-and-forth.

Toward “primary tier approval”: building Hong Kong as an innovation hub

Hong Kong’s 2025 Policy Address signaled an intention to accelerate institutional reforms supporting pharmaceuticals and medical devices, reinforcing the city’s positioning as an international medical innovation hub.

Looking ahead, the Department of Health will continue preparatory work toward a “primary tier approval” (第一層審批) model for new drug registration—gradually strengthening the local approval system. The broader goal is to inject momentum into Hong Kong’s—and the region’s—health industry development and market expansion, while increasing Hong Kong’s attractiveness for clinical development and innovation.