Hong Kong approves 22nd drug under 1+ scheme
RTHK · 2 SOURCESabout 1 hour ago2 MIN
Summary
Hong Kong's Department of Health said another new medicine has been registered under the “1+” drug approval mechanism, raising the total number approved through the pathway to 22. The newly approved product is for chronic spontaneous urticaria and had already been authorised by the United States drug regulator before its Hong Kong application was assessed.
Key Points
- The Pharmacy and Poisons Board's Registration Committee reviewed clinical data and related materials, and also consulted local experts before approving the drug's Hong Kong registration.
- The Department of Health said chronic spontaneous urticaria is a chronic skin disease marked by recurrent, unpredictable itching and hives that can seriously affect quality of life
- Officials said the newly approved medicine will help provide sustained improvement in symptoms for patients with the condition
- Of the drugs approved under the mechanism so far, seven have been added to the Hospital Authority Drug Formulary, including six listed as “special drugs”
- Eligible patients prescribed those formulary drugs under specified clinical conditions pay the standard fee of HK$20 every four weeks, while authorities are also shortening first-phase cancer drug reviews from up to 150 working days to within 100 days
Why It Matters
For Hong Kong patients, the latest approval adds another treatment option under a faster registration route and may improve access if more products move from approval into the public healthcare system. The large number of industry enquiries suggests drugmakers from Hong Kong, the mainland and overseas are watching the expanded mechanism closely for future applications, including advanced therapy products.