Hong Kong approves another prostate cancer drug under 1+
Crhk · 2 SOURCESabout 2 hours ago2 MIN
Summary
Hong Kong has approved another new medicine under the “1+” drug registration mechanism, adding a treatment for metastatic hormone-sensitive prostate cancer to the city’s register. The government said the drug had already been approved by a mainland drug regulator before being assessed in Hong Kong under the Pharmacy and Poisons Board’s registration process. The latest approval raises the number of new drugs registered under the mechanism to 23. Authorities also said they are working to shorten the first-phase review time for anti-cancer drugs from up to 150 working days to within 100 days.
Key Points
- The newly approved medicine is indicated for metastatic hormone-sensitive prostate cancer and had already secured approval from a mainland drug regulatory authority before its Hong Kong application.
- The Registration Committee under the Pharmacy and Poisons Board reviewed clinical data and related materials, and also consulted local experts before granting registration.
- After the assessment, the committee concluded that the drug met the required standards on safety, efficacy and quality for registration in Hong Kong.
- With this case, the total number of new drugs approved under the “1+” mechanism has increased to 23, according to the government.
- The government said seven new drugs approved under the mechanism have entered the Hospital Authority Drug Formulary, with six listed as “special drugs”
Why It Matters
For Hong Kong patients, the practical issue is not only whether a drug is approved, but how quickly it can move from registration into public-system use. The government’s effort to shorten anti-cancer drug reviews, together with Hospital Authority formulary inclusion for some “1+” medicines, points to a faster route from regulatory approval to treatment access in the city