HatchMed wins marketing for ELUNATE® (fruquintinib)

— First drug approved under Hong Kong Special Administrative Region Government’s new ‘1+’ mechanism provides important treatment option for Hong Kong patients —

— Erunate^® This is the first oral targeted therapy approved for metastatic colorectal cancer in Hong Kong in nearly a decade, regardless of biomarker status or previous treatment.

— Fruquintinib is already approved in mainland China, Macau Special Administrative Region, and the United States —

SHANGHAI, China and FLORHAM PARK, N.J., Jan. 29, 2024 (Globe Newswire) — HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (“HUTCHMED”) announced today that it is manufacturing ELUNATE. marketing approval^® (fruquintinib) has been approved by the Hong Kong Pharmacy and Toxic Substances Control Bureau for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”).Erunate^® 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 is the first drug to be approved under the New Drug Registration Mechanism (‘1+’ Mechanism) announced by the Hong Kong Special Administrative Region (‘SAR’) Government in October last year. This mechanism was officially launched on November 1, 2023. This mechanism allows medicines useful in the treatment of life-threatening or severely debilitating diseases to be applied for registration for use in Hong Kong, provided there is supporting local clinical data and approval from relevant experts. Allowed. They are only approved by one reference medicines regulatory authority (rather than two as in other cases). HATCHMED has submitted an application based on the approval of ELUNATE^® Information from the National Medical Products Administration of China (“NMPA”) is supported by 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 all we can to bring the benefits of our innovative medicines to our birthplace of Hong Kong, where our first medicines were approved. I’m excited about that.” Dr. Karen Atkin, Executive Vice President and Chief Operating Officer Hatch Med’s. “We appreciate the streamlining of the drug registration process, demonstrating the Hong Kong government’s efficiency and commitment to facilitating patient access to new treatments. New drug candidates in other types of cancer and immune diseases As we advance our pipeline, we look forward to delivering additional treatments that will benefit patients in Hong Kong.”

This approved indication is for patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy, and who have previously received anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy. Intended for patients who have or are not suitable to receive (RAS wild type).

“Colorectal cancer is the second most common cancer type in Hong Kong, and effective treatment options are limited, especially for patients with previously treated metastatic colorectal cancer,” he said. Dr. Caron Li, Vice President of Oncology and Immunology for Hong Kong and Regional Markets Hatch Med’s. “Fruquintinib has demonstrated clinically meaningful benefit and a consistent safety profile in global clinical trials as an orally administered third-line therapy. We are honored to be a member of the team and look forward to bringing this important treatment option to patients in Hong Kong as soon as possible.

Dr. Stephen Chan, academic and medical oncology expert“Cancer has been on the rise in incidence over the past few decades, and remains a major challenge for patients, their families, and us as healthcare professionals. The nature of this makes it especially difficult for researchers to bring new advances in treatment. Homegrown innovations are playing an increasingly active role in addressing the world’s unmet medical needs. It’s really heartening to see this happen and we’re excited to be able to offer such a meaningful treatment option to cancer patients in Hong Kong.”

Fruquintinib is marketed and marketed in Hong Kong by HUTCHMED under the trade name ELUNATE.^®. Developed and commercialized in mainland China in partnership with Eli Lilly & Company. Takeda holds an exclusive worldwide license for fruquintinib, excluding mainland China, Hong Kong and Macau. Takeda Pharmaceutical sells fruquintinib in the United States under the brand name Fruzakura™. Fruquintinib was added to the National Comprehensive Cancer Network Oncology Clinical Practice Guidelines (NCCN Guidelines) shortly after FDA approval.

About Hong Kong CRC

CRC is cancer that starts in the colon or rectum. In 2021, it was the second most common cancer in Hong Kong, with approximately 5,900 new patients diagnosed and approximately 2,300 deaths.¹ Although early-stage colorectal cancer can be surgically resected, metastatic colorectal cancer remains an area of ​​high unmet need, poor prognosis, and limited treatment options. Some patients with metastatic colorectal cancer may benefit from individualized treatment strategies based on molecular characteristics. However, most patients have tumors that do not have actionable mutations.^{2,3,Four,Five,6}

About fruquintinib

Fruquintinib is a selective oral inhibitor of VEGF receptors (“VEGFR”) -1, -2, and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib is designed with enhanced selectivity to limit off-target kinase activity, allowing flexibility for high drug exposure, sustained target inhibition, and potential use as part of combination therapy It has been. Fruquintinib has shown a manageable safety profile and is being studied in combination with other anticancer therapies.

Regarding the approval of fruquintinib in China

Fruquintinib was approved for sale in China in September 2018 and is co-marketed by HUTCHMED and Lilly under the brand name ELUNATE.^®. It was included in China’s National Reimbursable Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO trial, a pivotal Phase III registration study of fruquintinib in 416 patients with metastatic colorectal cancer in China. Journal of the American Medical Association, JAMA. Since its launch in China, fruquintinib has benefited more than 80,000 colorectal cancer patients as of mid-2023.

Regarding the approval of fruquintinib in the United States

Fruquintinib was approved in the United States in November 2023 and is sold by Takeda under the brand name FRUZAQLA™. This approval was based on data from two large Phase III trials. Data from his multi-regional FRESCO-2 trial lancet, in conjunction with the FRESCO trial conducted in China. This trial investigated fruquintinib plus best supportive care versus placebo plus best supportive care in previously treated mCRC patients. Both FRESCO and FRESCO-2 met the primary efficacy endpoint and key secondary efficacy endpoints and demonstrated consistent benefit in a total of 734 patients treated with fruquintinib. The safety profile was consistent across trials.

About HatchMed

HatchMed (Nasdaq/AIM: HCM; HKEX: 13) is an innovative commercial-stage biopharmaceutical company. We are committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immune diseases. The company employs approximately 5,000 people, with a core team of approximately 1,800 in oncology/immunology. Since its founding, the company has focused on discovering cancer drug candidates in-house and delivering them to patients around the world, with its first three drugs sold in China and the first of them in the U.S. It’s also on sale. See below for more information. www.hutch-med.com or follow us linkedin.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect current expectations regarding future events, including expectations regarding HatchMed’s therapeutic potential. Fruquintinib will be used for the treatment of CRC patients and further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. These risks and uncertainties include, among other things, assumptions regarding the efficacy and safety profile of fruquintinib; the ability of HATCHMED and/or its licensees to fund, conduct and complete further clinical development and commercialization plans for fruquintinib; The timing of these events. the ability of HATCHMED and its licensees to meet their obligations; regulatory actions that may impact the initiation, timing or progression of clinical trials or the regulatory pathway for fruquintinib; the ability of HatchMed and its licensees to successfully develop, manufacture and commercialize fruquintinib; the impact of COVID-19 on general economic, regulatory and political conditions; Additionally, because certain studies have relied on the use of other medications as combination therapy with fruquintinib, such risks and uncertainties may affect the safety, efficacy, availability, and continuity of these treatments. Contains assumptions regarding regulatory approvals. Such forward-looking statements include, but are not limited to, statements regarding our plans to develop, manufacture and commercialize fruquintinib. HatchMed’s strategy, goals, anticipated milestones, business plans, and focus. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For more information on these and other risks, please refer to HatchMed’s filings with the U.S. Securities and Exchange Commission regarding AIM and the Hong Kong Stock Exchange. HATCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

medical information

This press release contains information about products that may not be available in all countries or are available under different trademarks, different indications, different doses, or different strengths. Nothing contained herein should be construed as a solicitation, promotion, or advertisement for prescription drugs, including those currently in development.

contact address

Investor inquiries	+852 2121 8200 / ir@hutch-med.com
Media inquiries
Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (mobile phone) / +44 7779 545 055 (mobile phone) / HUTCHMED@fticonsulting.com
Shuyi, Brunswick	+852 9783 6894 (mobile) / HUTCHMED@brunswickgroup.com
designated advisor
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¹ Hong Kong Cancer Registry, Hospital Authority. Colorectal Cancer 2021. Available at https://www3.ha.org.hk/cancereg/pdf/factsheet/2021/colorectum_2021.pdf
² Hiroshi Bando et al. Treatment prospects and future directions for metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.
³ D’Haene N et al. Clinical application of targeted next generation sequencing in patients with colorectal cancer: A multicentric Belgian experience. Onco target. 2018;9(29):20761-20768. Published April 17, 2018. doi:10.18632/oncotarget.25099.
^Four Benderbosch et al. Mismatch repair status and braf mutation status in patients with metastatic colorectal cancer: An integrated analysis of Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Research Institute, 2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
^Five Koopman, M., et al. Deficiency of mismatch repair systems in patients with sporadic advanced colorectal cancer. Br J Cancer. 209;100(2), 266–273. doi:10.1038/sj.bjc.6604867.
⁶ Afsen Jabara S et al. HER2 in colorectal cancer: a long and winding path from negative predictor to positive actionable target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.