Hutchmed announces marketing approval of Elunate in Hong Kong

Hutchmed announced that the marketing approval of Elunate by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer, or CRC. Elunate is a selective oral inhibitor of vascular endothelial growth factor, or 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 announced by the Government of the Hong Kong Special Administrative Region 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. Hutchmed submitted the application based on the approval of Elunate from the China National Medical Products Administration, or NMPA, supported with local clinical data. Fruquintinib was also approved by the FDA in November 2023.