Two new drugs have been approved for registration in Hong Kong under the "1+" mechanism.

On December 16, a spokesperson for the Hong Kong government announced that two new drugs have been approved for registration in Hong Kong under the "1+" mechanism. These two drugs in different doses are used to treat advanced small cell lung cancer, providing patients with more treatment options and showcasing Hong Kong as a "good drug hub". Since the implementation of the "1+" mechanism, a total of nine new drugs have been approved for registration under this mechanism. In addition, the Department of Health in Hong Kong will continue to promote the reform of the drug and medical device approval mechanism announced in the Chief Executive's Policy Address for 2024, including establishing a timetable for the establishment of the "Hong Kong Drug and Medical Device Regulatory Center" by the first half of 2025, moving towards a "first-layer approval" route, and implementing strategies and measures to support drug research and development. It is reported that the new drugs for the treatment of advanced small cell lung cancer have been approved by the US drug regulatory agency and have submitted registration applications under the "1+" mechanism. After the Registration Committee under the Pharmacy and Poisons Board of Hong Kong reviewed the clinical data and relevant information submitted by the applicants and consulted local experts, it was determined that these new drugs meet the relevant safety, efficacy, and quality standards, and were approved for registration in Hong Kong. The Department of Health in Hong Kong has informed the applicants of the approval results. Public information shows that Hong Kong implemented the "1+" mechanism on November 1, 2023, to facilitate the registration of new drugs for the treatment of severe or rare diseases, and expanded the "1+" mechanism to include all new drugs on November 1 this year, including products and drugs with new active ingredients or biological elements, new indications, vaccines, and advanced therapy products. If new drugs can provide local clinical data that meets the requirements and are approved by local experts, they only need to submit one (instead of the original two) reference drug regulatory agency, and can apply for registration in Hong Kong.