Hong Kong has registered a new medicine for chronic spontaneous urticaria, commonly known as chronic hives, bringing the number of drugs approved through the city’s “1+” mechanism to 22 since its launch in 2023.
The medicine had previously been approved by a US drug regulatory authority. Hong Kong’s Registration Committee under the Pharmacy and Poisons Board reviewed clinical data, consulted local experts and concluded that it met the relevant safety, efficacy and quality requirements.
The supplied reports said the medicine was expected to provide sustained improvement in itching, hives or overall symptom control. That reported expectation does not establish the outcome for every patient.
Under the “1+” mechanism, a medicine supported by local clinical data and recognised by local experts can apply for registration using approval from one external drug regulator, rather than two. The pathway was introduced in 2023.
The Department of Health said it had received more than 910 enquiries from over 220 pharmaceutical companies about the mechanism. The figures indicate interest in the pathway but do not mean that all the enquiries resulted in applications or approvals.
The medicine was registered by August 31, 2026. The supplied reports do not state its name, prescribing conditions, availability or cost in Hong Kong, or the exact date on which the registration decision was made.