Chi-Med and Eli Lilly Expand Collaboration to Commercialize Elunate® (Fruquintinib) in China

HONG KONG, SHANGHAI and FLORHAM PARK, N.J., July 28, 2020 /PRNewswire/ -- HUTCHMED (China) Limited (“HUTCHMED“or ‘Chi-Med’) (NASDAQ/LSE: HCM) today announced, in partnership with Eli Lilly and Company (“Eli Lilly”), an amendment to the fruquintinib license and collaboration agreement originally signed in 2013 with Eli Lilly’s subsidiary, Eli Lilly Shanghai. This 2020 amendment further expands HUTCHMED’s responsibilities for the commercialization of ELUNATE® (fruquintinib capsules) in China.

Pursuant to the provisions of the 2020 amendment, Eli Lilly will continue to enjoy rights to Opdivo^® exclusive commercialization rights in China, and will therefore continue to consolidate Aiyoute in its financial statements^® Sales in China. HUTCHMED will collaborate with Eli Lilly to jointly promote Fruquintinib^®(Fruquintinib Capsules) commercialization activities across China.

In the joint statement, Mr. Christian Hogg, Chief Executive Officer of HUTCHMED, and Mr. Julio Gay-Ger, President and General Manager of Eli Lilly China, stated: “Following years of constructive and successful collaboration, both HUTCHMED and Eli Lilly are firmly convinced that this agreement establishes an optimal framework to fully leverage the resources of both companies and realize the potential of Fruquintinib^®"Maximize commercial potential in China."

Effective October 1, 2020, HUTCHMED will be responsible for the development and execution of FRUZAQLA through its oncology commercialization team comprising more than 320 employees.^® All medical information communication, promotion, and local and regional market activities in the Chinese market. Eli Lilly and HUTCHMED will continue their cooperation as always, working together to develop and execute strategies for Fruquintinib^®Overall market strategy and nationwide marketing activities in China.

HUTCHMED and Eli Lilly to Share Fruquintinib^® Gross profit linked to sales target performance. Based on the predetermined sales targets, Eli Lilly will pay HUTCHMED an amount equivalent to that of Fruquintinib in the form of royalty fees, production costs, and service fees.^® 70%-80% of the total sales amount. Neither party involves prepayment for this amendment.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2, and 3. VEGFR inhibitors play a crucial role in suppressing tumor angiogenesis. The unique design of fruquintinib confers higher kinase selectivity, resulting in lower off-target toxicity, better tolerability, and more stable target coverage. Preclinical studies have demonstrated a low potential for drug-drug interactions, making it an ideal candidate for combination therapy with other cancer treatments.

HUTCHMED holds all rights to fruquintinib outside of China and collaborates with Eli Lilly on the development and commercialization of fruquintinib within China.

Fruquintinib for the Treatment of Metastatic Colorectal Cancer

Fruquintinib was approved for sale in China by the National Medical Products Administration (“NMPA”) of China in September 2018, and was launched by Eli Lilly under the brand name Elunate at the end of November 2018.^® Conduct commercial promotion. Aiyoute^® Indicated for patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidines, oxaliplatin, and irinotecan, including those who have previously received anti-vascular endothelial growth factor (VEGF) therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (for RAS wild-type tumors). The results of the FRESCO study, a pivotal Phase III registration trial of fruquintinib, were published in June 2018 in the Journal of the American Medical Association (JAMA).Publish(ClinicalTrials.gov registration number:NCT02314819). This study included a total of 416 Chinese patients with metastatic colorectal cancer.

In December 2017, HUTCHMED initiated a Phase Ib clinical trial in the United States to evaluate fruquintinib for the treatment of patients with advanced solid tumors. In 2019, proof-of-concept cohorts for the treatment of patients with metastatic colorectal cancer and metastatic breast cancer were added to the study (ClinicalTrials.gov registration number:NCT03251378）。

HUTCHMED is planning to initiate FRESCO-2, a randomized, double-blind, placebo-controlled, multicenter Phase 3 registration study of fruquintinib in patients with refractory metastatic colorectal cancer, in the United States, Europe, and Japan. The primary efficacy endpoint of the study is overall survival (OS). The study plans to enroll more than 500 patients from approximately 130 investigative centers across 10 countries. In June 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to fruquintinib for the treatment of metastatic colorectal cancer. The study design of FRESCO-2 has also been reviewed and accepted by the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan (ClinicalTrials.gov registration number:NCT04322539）。

Other Development Plans for Fruquintinib

Research on Gastric Cancer in China:In October 2017, HUTCHMED initiated the FRUTIGA study. The FRUTIGA study is a randomized, double-blind, Phase III clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer or gastroesophageal junction adenocarcinoma. The study planned to enroll patients who had not responded to first-line standard chemotherapy. Participants received either fruquintinib plus paclitaxel or placebo plus paclitaxel. The primary efficacy endpoint was overall survival. In June 2020, HUTCHMED completed a prespecified interim analysis. Based on prespecified criteria, the Independent Data Monitoring Committee (IDMC) recommended that the study continue (ClinicalTrials.gov registration number:NCT03223376）。

Combination Immunotherapy:HUTCHMED has entered into three collaboration agreements to evaluate the safety, tolerability, and efficacy of fruquintinib in combination with PD-1 monoclonal antibody therapy, includingTislelizumab（BGB-A317）、Tyvyt®(Sintilimab, IBI308) andGenolimab（GB226，Geptanolimab）。

About HUTCHMED

HUTCHMED (China) Limited (“HUTCHMED” or “Chi-Med”) (NASDAQ/LSE: HCM) is an innovative, commercial-stage biopharmaceutical company that has been dedicated to the discovery and global development of targeted therapies and immunotherapies for cancer and autoimmune diseases over the past 20 years. Currently, HUTCHMED has nine oncology drug candidates in global development and possesses an extensive commercial network in the domestic Chinese market. For more information, please visit:www.chi-med.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leader in the pharmaceutical industry, dedicated to improving human health through innovation. Founded more than a century ago, the company was established with a commitment to producing high-quality medicines that meet real medical needs. Today, we remain steadfast in this mission and guide our work by it. Around the world, our employees strive to discover and develop transformative medicines and deliver them to patients who truly need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through charitable initiatives and volunteer activities. For more information about Eli Lilly and Company, please visit:www.lilly.com。

HUTCHMED Forward-Looking Statements

This press release contains1995forward-looking statements as defined in the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including expectations concerning its collaboration with Eli Lilly and Company and maximizing the potential of Fruquintinib in accordance with the aforementioned amendment^®Commercial potential capabilities in China. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include the following assumptions: HUTCHMED regarding Fruquintinib in China^®Successfully conducted medical information communication, promotion, and local and regionalMarketactivities, and that no unknown side effects will emerge that could lead the National Medical Products Administration to withdraw fruquintinib from the market; the sufficiency of funding for the commercialization and further clinical development and plans of fruquintinib for colorectal cancer and other indications; and the impact of the global COVID-19 pandemic on overall economic, regulatory, and political conditions. Current and potential investors are cautioned not to place undue reliance on these forward-looking statements, which are valid only as of the date of this announcement. For further discussion of these and other risks, please refer to HUTCHMED’s filings with the U.S. Securities and Exchange Commission andAIMSubmitted documents. HUTCHMED assumes no obligation to update or revise the information contained in this press release, regardless of whether new information, future events or circumstances, or other factors arise.

Insider Information

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