HUTCHMED Announces License to Takeda to Develop and Commercialize Fruquintinib Outside China

— HUTCHMED to receive US$400 million upfront on deal closing and up to US$730 million in potential future milestone payments, totaling up to US$1.13 billion, plus royalties on net sales —

— Marketing authorization submissions in the U.S., Europe and Japan planned to complete in 2023 —

— Partnership approach aligned with HUTCHMED’s path to profitability and strategy to bring its innovative medicines to patients worldwide —

— HUTCHMED to host a conference call and webcast at 8:30 a.m. EST (1:30 p.m. GMT / 9:30 p.m. HKT) on Monday, January 23, 2023  —

Hong Kong, Shanghai & Florham Park, NJ  — Monday, January 23, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM, HKEX:​13) today announces that its subsidiary, HUTCHMED Limited, has entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to further the global development, commercialization and manufacture of fruquintinib outside of mainland China, Hong Kong and Macau, where it is marketed by HUTCHMED. HUTCHMED Limited will receive up to US$1.13 billion including US$400 million upfront on closing as well as potential regulatory, development and commercial sales milestone payments, plus royalties on net sales. 

Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is orally administered and has the potential to be used across subtypes of metastatic colorectal cancer (“CRC”), regardless of biomarker status. Positive results of FRESCO-2, the global Phase III multi-regional clinical trial of fruquintinib in refractory metastatic colorectal cancer (“CRC”), were presented at the European Society for Medical Oncology Congress (“ESMO”) in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (“OS”) in patients with metastatic CRC and was generally well tolerated.

“We are pleased to be partnering with a company that shares our mission to improve treatment outcomes for cancer patients and has the scale and expertise in global drug development and commercialization to advance fruquintinib globally outside of China,” said Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED.

“For HUTCHMED, this transaction is consistent with our strategic shift that we announced in November 2022 to accelerate our path to profitability. We stated that we would focus on the innovative medicines in our pipeline such as fruquintinib and others that are most likely to generate near-term value, and that we would be uncompromising in our commitment to bringing our medicines to patients worldwide. Not only does the license with Takeda accelerate this global ambition, but it provides us with more bandwidth and extended cash runway to advance other opportunities.  We are very excited about the future for HUTCHMED.”

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “We have a strong track record of working with companies that share our focus on bringing transformative medicines to patients around the globe who need them. Working with HUTCHMED will enable us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer.”

Under the terms of the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib from HUTCHMED Limited in all indications and territories outside of mainland China, Hong Kong and Macau. Subject to the terms of the agreement, HUTCHMED Limited will be eligible to receive up to US$1.13 billion, including US$400 million upfront on closing of the agreement, and up to US$730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales.

The deal is subject to customary closing conditions, including completion of antitrust regulatory reviews. Following these clearances, Takeda will become solely responsible for the development and commercialization of fruquintinib in all included territories worldwide excluding mainland China, Hong Kong and Macau. As previously announced, marketing authorization submissions in the U.S., Europe and Japan are planned to complete in 2023, with the rolling submission to the U.S. Food and Drug Administration (“FDA”) planned to complete in the first half of 2023.

HUTCHMED will continue to focus on progressing late-stage clinical trials and the commercialization of fruquintinib in mainland China in collaboration with Eli Lilly and Company, where it is approved under the brand name ELUNATE^® for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-vascular endothelial growth factor therapy and/or anti-epidermal growth factor receptor (“EGFR”) therapy (RAS wild type). ELUNATE^® has been included in the China National Reimbursement Drug List (“NRDL”) since January 2020.

Management of HUTCHMED will host a conference call and webcast for investors and analysts on Monday, January 23, 2023, at 8:30 a.m. New York time (1:30 p.m. London time, 9:30 p.m. Hong Kong Time). Details of the conference call dial-in and the webcast link will be provided on the company website at www.hutch-med.com/event/. A replay will also be available on the website shortly after the event.

Evercore Group LLC is acting as exclusive financial advisor to HUTCHMED and Ropes & Gray LLP is serving as its legal advisor.