Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: 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.”

This approval indication is for patients with metastatic CRC who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type).

“CRC is the second most common cancer type in Hong Kong with limited effective treatment options available, especially for previously treated metastatic CRC patients,” said Dr Caron Li, Vice President, Oncology and Immunology, Hong Kong and Regional Markets of HUTCHMED. “Fruquintinib, as a third-line treatment administered orally, demonstrated clinically meaningful benefits and a consistent safety profile in global clinical trials. We are honored to be the first through the “1+” mechanism and look forward to bringing this important treatment option to patients in Hong Kong as quickly as possible.

Dr Stephen Chan, an academic and a specialist in Medical Oncology, said, “Cancer remains to be a major challenge for the patients, their families and us as healthcare providers, with a rising trend in incidence over the past decades. The complex nature of cancer has made it particularly arduous for researchers to bring new advancements to the treatment. It is truly encouraging to see homegrown innovations taking on an increasingly active role to address the global unmet medical needs. We are excited to bring such meaningful treatment options to the cancer patients in Hong Kong.”

Fruquintinib will be sold and marketed in Hong Kong by HUTCHMED under the brand name ELUNATE®. It has been developed and commercialized in mainland China in partnership with Eli Lilly & Company. Takeda has the exclusive worldwide license to fruquintinib outside of mainland China, Hong Kong and Macau. Takeda markets fruquintinib in the United States under the brand name FRUZAQLA™. Fruquintinib was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) shortly after FDA approval.

https://www.hutch-med.com/elunate-fruquintinib-marketing-approval-in-hong-kong/