New prostate cancer drug approved under Hong Kong's '1+' mechanism
Hong Kong has approved a new drug for metastatic hormone-sensitive prostate cancer under its '1+' drug registration mechanism, bringing the total to 23. The drug was approved by China's drug regulator and reviewed by local experts. The government aims to expand first-layer approval by 2030.
Hong Kong has approved another new drug under its "1+" drug registration mechanism, this time for metastatic hormone-sensitive prostate cancer, the Department of Health announced on Thursday. The drug had already been approved by mainland China's drug regulator before its application was submitted under the mechanism.
The Registration Committee of the Pharmacy and Poisons Board reviewed the applicant's clinical data and consulted local experts before concluding that the drug met the required safety, efficacy and quality standards. The Department of Health has notified the applicant of the approval result.
With this latest approval, 23 new drugs have now been registered under the "1+" mechanism since it took effect on 1 November 2023. Seven of these have been included in the Hospital Authority's drug formulary, with six placed under the "special drugs" category, meaning eligible patients pay only the standard fee of $20 every four weeks. The authority's Office for Introducing Innovative Drugs and Medical Devices, established on 8 June, is working with the Department of Health to speed up registration of new products, with review times for cancer drugs cut from a maximum of 150 working days to within 100 days.
The "1+" mechanism, expanded on 1 November 2024 to cover all new drugs including advanced therapy products, allows applicants to submit one reference regulatory approval instead of two, provided they supply qualifying local clinical data endorsed by local experts. The department has received more than 920 enquiries from over 230 pharmaceutical companies and has launched pre-submission consultation services and workshops.
The mechanism is seen as a stepping stone to "first-layer approval", which the Department of Health began implementing in phases on 31 March 2026. The first phase covers extensions of drugs already registered in Hong Kong, with a target of full coverage of all pharmaceutical products by 2030, enabling Hong Kong to independently assess and approve new drugs based on clinical data.
The government said it will continue deepening regulatory reforms and establish a Hong Kong Drug and Medical Device Regulatory Authority within 2026, aiming to position Hong Kong as an international medical innovation hub under the city's first five-year plan and the 2026 policy address.