A Government spokesman announced today (February 19) that two more new drugs submitted for registration under the new drug approval mechanism ( "1+" mechanism) have been approved for registration in Hong Kong. These new drugs in two different dosages are used to treat patients with locally advanced or metastatic non-small cell lung cancer, bringing more treatment options for patients in Hong Kong and facilitating more good drugs for use in Hong Kong.
 
     The Hong Kong Special Administrative Region (HKSAR) Government has implemented the "1+" mechanism since November 1, 2023, for facilitating the registration of new drugs used for the treatment of life-threatening or severely debilitating diseases in Hong Kong. With effect from November 1 last year, the "1+" mechanism has been extended to all new drugs, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. New drugs that are supported by local clinical data and recognised by local experts can be applied for registration in Hong Kong by submitting approval from one reference drug regulatory authority (instead of two in the past).
 
     The above products for locally advanced or metastatic non-small cell lung cancer have been approved by the drug regulatory authority on the Mainland and submitted for registration application in Hong Kong under the "1+" mechanism. Having evaluated the clinical data and relevant information submitted by the applicant and advice given by a local expert, the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considered that the new drugs satisfied the criteria of safety, efficacy and quality, and approved the registration of the new drugs. The Department of Health (DH) has already notified the applicant of the result of the applications.
 
     The extended "1+" mechanism serves to attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards "primary evaluation".
      
     Since the implementation of the "1+" mechanism, a total of 11 new drugs have been approved under this mechanism. The DH has been promoting the "1+" mechanism through different channels and so far has received more than 370 enquiries from over 100 pharmaceutical companies, including those from overseas and the Mainland. Many companies have expressed interests in submitting applications for registration of their products, including advanced therapy products, under the extended "1+" mechanism.

     As announced in "The Chief Executive's 2024 Policy Address", the Government will expedite the reform of the approval mechanism for drugs and medical devices, while the DH shall put forward a timetable for establishing the Hong Kong Centre for Medical Products Regulation and chart a roadmap towards "primary evaluation" in the first half of this year to expedite patients' access to advanced diagnostic and treatment services, to foster new quality productive forces in biomedical technology, and to develop Hong Kong into an international health and medical innovation hub. 

Ends/Wednesday, February 19, 2025
Issued at HKT 17:15

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