— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial —

— FRUZAQLA^® (fruquintinib) is the first novel targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade —

HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/NYSE:TAK) has received notification from the European Commission (“EC”) that it has approved FRUZAQLA^® (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (“CRC”) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.

“With fruquintinib being the first and only selective inhibitor of all three VEGFRs to be approved in the EU for colorectal cancer, this decision represents a significant milestone in European oncology,” added Josep Tabernero, MD, PhD, director of Vall d’Hebron Institute of Oncology (VHIO). “There is a clear need in Europe for patients and their clinicians to be able to access a new treatment option for previously treated metastatic colorectal cancer, and we are excited that this important step has been taken so that we can begin prescribing this new and differentiated medicine.”

“We are delighted to have achieved EC approval for FRUZAQLA^® and that we can now offer a new therapeutic option for patients with previously treated metastatic colorectal cancer, regardless of their biomarker status,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “Patients in Europe with metastatic colorectal cancer have long needed additional treatment options, and we are grateful to be able to meet that need thanks to our partnership with HUTCHMED.”

“This is a significant milestone for HUTCHMED, as it is the first product from our research and discovery engine to be approved in Europe, achieved through our partnership with Takeda to make this possible in such a short period of time,” added Weiguo Su, PhD, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “This novel oncology medicine is currently improving the treatment outlook in the U.S. and China, and we look forward to seeing its impact for patients across Europe.”

The EC’s approval has been granted following a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) in April 2024. The CHMP’s opinion was primarily based on results from the Phase III multiregional FRESCO-2 trial, which supported the Marketing Authorisation Application (“MAA”) that was validated and accepted for review in June 2023. Data from FRESCO-2 were published in The Lancet in June 2023.