HUTCHMED Receives ELUNATE (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

— First medicine approved under new “1+” mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong —

— ELUNATE is the first oral targeted therapy approved in Hong Kong for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in almost a decade —

— Fruquintinib already approved in mainland China, Macau SAR and the United States —

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Jan. 29, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis.

This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition from relevant experts, when they have been approved by only one reference drug regulatory authority (instead of two otherwise). HUTCHMED submitted the application based on the approval of ELUNATE from the China National Medical Products Administration (“NMPA”) supported with local clinical data. Fruquintinib was also approved by the U.S. Food and Drug Administration (“FDA”) in November 2023.

“We have made it a priority to do everything we can to bring the benefits of our innovative medicines to Hong Kong, our Company's birthplace, and are excited to have our first medicine now approved here,” said Dr Karen Atkin, Executive Vice President and Chief Operating Officer of HUTCHMED. “We appreciate the streamlined drug registration process, showing the efficiency and commitment of the Hong Kong government to accelerate patient access to novel therapies. As we advance our pipeline of drug candidates in other cancer types and immunological diseases, we look forward to bringing additional therapies to benefit patients in Hong Kong.”