U.S. approval of FRUZAQLA triggers first milestone payment from Takeda of US$35 million and royalties on net sales

HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”)  announced that its partner Takeda received approval from the U.S. Food and Drug Administration (“FDA”) for FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (“CRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑vascular endothelial growth factor (“VEGF”) therapy, and, if RAS wild‑type and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy. FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.^1,2 This approval was received under Priority Review more than 20 days ahead of the scheduled Prescription Drug Users Fee Act (PDUFA) date of November 30, 2023.

“This is a landmark moment for metastatic colorectal cancer patients in the U.S., who will soon have a much-needed new treatment option that improves survival rates without negatively impacting their quality of life,” said Weiguo Su, PhD, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “It is also a landmark moment for HUTCHMED, as we see our first medicine approved outside of our home market, where we have been improving patient outcomes with our novel oncology medicines for the last 5 years. In late 2022 we launched a partnership strategy for globalizing our innovative drug candidates and we are pleased to see early delivery of this new approach just a year later. This initial success is thanks to our partner Takeda, who saw the value in fruquintinib, shared our vision for taking it global, and worked hard with us to secure U.S. approval. We look forward to continuing our work with Takeda in an effort to bring FRUZAQLA to patients across the globe.”

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. The FDA approval of FRUZAQLA triggers a US$35 million milestone payment from Takeda. HUTCHMED will receive royalties on net sales, and is also eligible to receive potential payments relating to other regulatory, development and commercial sales milestones. Fruquintinib is developed and marketed in China by HUTCHMED following approval in September 2018, under the brand name ELUNATE™, in partnership with Eli Lilly and Company.

“For more than a decade there has been limited innovation for patients with metastatic colorectal cancer, one of the leading causes of cancer death in the U.S.,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “We are proud that our partnership with HUTCHMED enabled us to bring forth a new option to this patient population and we look forward to continuing our work for patients with this underserved cancer.”

The approval of FRUZAQLA is based on data from two large Phase III trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA, The Journal of the American Medical Association. The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC. Both FRESCO and FRESCO-2 met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with FRUZAQLA. Safety profiles were consistent across trials.

“Metastatic colorectal cancer patients often present with inoperable disease. As cancer care providers, we must evaluate and consider treatment options that will improve overall survival without compromising quality of life,” said Cathy Eng, M.D., FACP, at Vanderbilt University Medical Center. “A selective oral anti-VEGF agent with proven benefit in overall survival and demonstrated a manageable safety profile would be advantageous for patients by continuing the treatment paradigm of anti-VEGF therapy at home.”

In the U.S., approximately 153,000 new cases of CRC will be diagnosed in 2023, representing 7.8% of all new cancer cases.^3,4 Approximately 70% of patients with CRC will experience metastatic disease, whether at diagnosis or after treatment. Metastases are the main cause of CRC-related mortality.^5,6

The data from FRESCO and FRESCO-2 also supported the marketing authorization application (“MAA”) for fruquintinib, which was validated and accepted for review by the European Medicines Agency (“EMA”) in June 2023. A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023.