Drugs / Fruquintinib
Fruquintinib
also known as
ELUNATE · HMPL-013 · Fruquintinib+ chemotherapy · Aiutec · Fruquintinib Capsules · Fruzaqla
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 6 milestones | |||||
| Filed | Japan (PMDA) | — | colorectal cancer | 2023-09-29 | “A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) also took place in September 2023.” takeda.com ↗ “A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) also took place in September 2023.” takeda.com ↗ “A submission to the Japan Pharmaceuticals and Medical Devices Agency (“PMDA”) took place in September 2023.” hutch-med.com ↗ “a submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023.” hutch-med.com ↗ “A submission to the PMDA also took place in September 2023.” hutch-med.com ↗ |
| Filed | EU (EMA) | — | colorectal cancer | 2023-06-15 | “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...” hutch-med.com ↗ “The data from FRESCO and FRESCO-2 also supported the EU marketing authorization application (MAA) for fruquintinib, which was validated and accepted for review by the European...” takeda.com ↗ “the European Medicines Agency (“EMA”) has validated and accepted for regulatory review the marketing authorization application (“MAA”) for fruquintinib” hutch-med.com ↗ “the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib” hutch-med.com ↗ “The Phase III FRESCO and FRESCO-2 trials supported the MAA from the EMA for fruquintinib, which was validated and accepted for review in June 2023.” hutch-med.com ↗ “A Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was validated and accepted for regulatory review in June 2023.” hutch-med.com ↗ “marketing authorization application (MAA) from the EMA for fruquintinib, which was validated and accepted for review in June 2023.” takeda.com ↗ “In addition, a submission to the European Medicines Agency (“EMA”) was validated and accepted for review in June 2023” hutch-med.com ↗ |
| Filed | US (FDA) | — | colorectal cancer | 2023-05-25 | “The validation follows the acceptance by the U.S. Food and Drug Administration (“FDA”) of a new drug application (“NDA”), announced on May 25, 2023” hutch-med.com ↗ |
| Filed | US (FDA) | — | colorectal cancer | 2023-03-31 | “today announces that it completed the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for fruquintinib” hutch-med.com ↗ |
| Filed | US (FDA) | — | colorectal cancer | 2022-12-19 | “has initiated the filing of a rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for fruquintinib” hutch-med.com ↗ |
| Filed | China (NMPA) | — | colorectal cancer | 2017-06-12 | “CFDA has acknowledged acceptance of the New Drug Application (“NDA”) for fruquintinib for the treatment of patients with advanced colorectal cancer” hutch-med.com ↗ “Submitted first China New Drug Application (“NDA”) on fruquintinib” hutch-med.com ↗ |
| Filed gastroesophageal adenocarcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | gastroesophageal adenocarcinoma | 2023-04-18 | “its New Drug Application (“NDA”) for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma...” hutch-med.com ↗ “China NDA accepted in China in second-line gastric cancer for fruquintinib in combination with paclitaxel in April 2023” hutch-med.com ↗ “An NDA to the NMPA was accepted in April 2023 for fruquintinib in combination with paclitaxel” hutch-med.com ↗ “Fruquintinib NDA for second-line gastric cancer accepted for review in China.” hutch-med.com ↗ |
| Filed renal cell adenocarcinoma 1 milestone | |||||
| Filed | China (NMPA) | ELUNATE® | renal cell adenocarcinoma | — | “Fruquintinib sNDA accepted by NMPA combined with sintilimab for 2L renal cell carcinoma in June.” hutch-med.com ↗ |
| Filed stage I endometrioid carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | stage I endometrioid carcinoma | — | “An NDA in China for fruquintinib in combination with sintilimab in endometrial cancer was accepted with priority review status in April 2024” hutch-med.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Fruzaqla | — | 2024-06-20 | europa.eu ↗ |
| Approved | US (FDA) | FRUZAQLA | — | 2023-11-08 | fda.gov ↗ |
Trials 165 · started per year
today
US approved 2023
EU approved 2024
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06380309 | May 2024 → Dec 2025 overdue | digestive system cancer | Peking University | Recruiting | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT05848739 | Jun 2023 → May 2026 overdue | colorectal cancer | Sapience Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT05216367 | Mar → Oct 2022 | — | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05216354 | Mar 2022 → Jun 2023 | impaired renal function disease | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT05368805 | Mar → Apr 2022 | colorectal cancer | Hutchmed | Completed | No outcome recorded |
| Phase 1 | NCT04645940 | Sep → Nov 2020 | — | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT04557397 | Sep → Oct 2020 | — | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT03976856 | Jul 2019 → Dec 2021 | non-small cell lung carcinoma | Genor Biopharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03977090 | Apr 2019 → Dec 2021 | colorectal cancer | Genor Biopharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03251378 | Dec 2017 → Dec 2022 | hormone receptor-positive breast cancer, malignant colon neoplasm, rectal cancer, triple-negative breast carcinoma | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT02689752 | Jul → Sep 2016 | — | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT01955304 | Jun → Sep 2012 | — | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT01645215 | Jan 2011 → Oct 2012 | neoplasm | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1/222 trials | ||||||
| Phase 1/2 | NCT07791758 | Sep 2026 → Sep 2030 expected | colorectal carcinoma | Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07621159 | Jul 2026 → Nov 2027 expected | colorectal cancer | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07591597 | May 2026 → Jul 2027 expected | colorectal cancer | National Cancer Center Hospital East | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07025850 | Aug 2025 → Jan 2027 expected | colorectal carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06980532 | Apr 2025 → Dec 2028 expected | colorectal cancer | Liu Huang | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06871527 | Mar 2025 → Mar 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06484153 | Jul 2024 → Jul 2026 overdue | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06329973 | Feb 2024 → Jun 2026 overdue | gastroesophageal junction adenocarcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07334431 | Feb 2024 → Dec 2025 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06195670 | Jan 2024 → Jan 2026 overdue | colorectal adenocarcinoma | Zhejiang Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06078670 | Oct 2023 → Jun 2026 | neoplasm | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT06010212 | Aug 2023 → Aug 2025 | esophageal squamous cell carcinoma | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07491159 | Jul 2023 → Jun 2026 overdue | colorectal cancer | Tianjin Medical University Cancer Institute and Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05982834 | May 2023 → May 2025 | carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05522738 | Aug 2022 → Dec 2024 | colorectal cancer | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05024812 | Jun 2022 → Aug 2023 | gastric cancer | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05016869 | Apr 2022 → Feb 2023 | colorectal cancer | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 1/2 | NCT04577963 | Aug 2021 → Jun 2024 | colorectal cancer, endometrial cancer, triple-negative breast carcinoma | Hutchmed | Terminated | No outcome recorded |
| Phase 1/2 | NCT04446091 | Jul 2020 → Jul 2021 | colorectal cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03903705 | Apr 2019 → Nov 2023 | neoplastic disease or syndrome | Hutchmed | Completed | No outcome recorded |
| Phase 1/2 | NCT02415023 | Nov 2014 → Mar 2017 | gastric cancer | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT01975077 | Dec 2012 → Apr 2014 | colorectal cancer | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 2102 trials · 1 met primary | ||||||
| Phase 2 | NCT07819019 | Oct 2026 → Oct 2028 expected | gastric cancer | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07689292 | Jul 2026 → Aug 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07658872 | Jun 2026 → May 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07622550 | Jun 2026 → Dec 2027 expected | colorectal cancer | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07502014 | May 2026 → Dec 2028 expected | colorectal cancer | Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07510932 | May 2026 → Mar 2027 expected | colon carcinoma | Korea University Anam Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07515820 | Apr 2026 → Jul 2027 expected | colorectal cancer | Meng Qiu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07042685 | Jan 2026 → Dec 2028 expected | colorectal cancer | The Methodist Hospital Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07353268 | Jan 2026 → Aug 2027 expected | colorectal cancer | Tao Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07286695 | Dec 2025 → Dec 2029 expected | colorectal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07150403 | Dec 2025 → Feb 2028 expected | colorectal carcinoma | Federation Francophone de Cancerologie Digestive | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07392346 | Dec 2025 → Nov 2027 expected | gastric adenocarcinoma | Dai, Guanghai | Recruiting | No outcome recorded |
| Phase 2 | NCT07261709 | Dec 2025 → Oct 2027 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07229872 | Dec 2025 → Dec 2026 expected | colorectal cancer | Harbin Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06992258 | Oct 2025 → Dec 2027 expected | colorectal cancer | Criterium, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06856837 | Oct 2025 → Dec 2029 expected | colorectal cancer | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07170982 | Oct 2025 → Oct 2027 expected | endometrial cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07011576 | Sep 2025 → Jan 2027 expected | colon carcinoma, rectal carcinoma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07136077 | Sep 2025 → Dec 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07130903 | Sep 2025 → Apr 2028 expected | colorectal adenocarcinoma | Barbara Ann Karmanos Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07488533 | Aug 2025 → Dec 2027 expected | nonpapillary renal cell carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07051785 | Jul 2025 → Jul 2027 expected | colorectal cancer | Liu Huang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06973421 | Jul 2025 → Jun 2027 expected | refractory malignant neoplasm | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05690035 | Jul 2025 | colorectal cancer, metastatic malignant neoplasm in the colon | Sun Yat-sen University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07003022 | Jun 2025 → May 2027 expected | colorectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06888037 | Mar 2025 → Mar 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06746545 | Feb 2025 → Aug 2026 overdue | colorectal cancer | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06979908 | Jan 2025 → Jul 2026 overdue | colorectal cancer | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| Phase 2 | NCT06446154 | Dec 2024 → Dec 2025 overdue | hepatocellular carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06706895 | Dec 2024 → Dec 2025 overdue | gastric cancer | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06685276 | Aug 2024 → Dec 2025 overdue | colorectal cancer | Dai, Guanghai | Recruiting | No outcome recorded |
| Phase 2 | NCT06513221 | Jul 2024 → Apr 2026 overdue | colorectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06487702 | Jul 2024 → Jun 2026 overdue | esophageal squamous cell carcinoma | Rui-hua Xu, MD, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06791083 | Jun 2024 → Dec 2025 overdue | gastric cancer | First Affiliated Hospital of Fujian Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06218888 | Jun 2024 → Dec 2025 overdue | colorectal cancer | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06406426 | May 2024 → May 2025 overdue | gastroesophageal junction adenocarcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06423937 | May 2024 → Jul 2026 overdue | colorectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06356597 | Apr 2024 → Dec 2026 expected | colorectal cancer | Jing-yuan Fang, MD, Ph. D | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06646588 | Apr 2024 → Apr 2026 overdue | neoplasm of esophagus | Hebei Medical University Fourth Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06356584 | Apr 2024 → Oct 2026 expected | metastasis from malignant tumor of colon | Shandong Cancer Hospital and Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06543836 | Dec 2023 → Nov 2025 overdue | colorectal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06234007 | Dec 2023 → Dec 2024 overdue | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06148402 | Nov 2023 → Dec 2025 | colorectal cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT06010888 | Oct 2023 → Oct 2024 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT06091423 | Oct 2023 → Nov 2025 overdue | gastroesophageal junction adenocarcinoma | Xiaofeng Chen | Recruiting | No outcome recorded |
| Phase 2 | NCT05842525 | Oct 2023 → May 2024 | colorectal cancer | Hunan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06094868 | Oct 2023 → Oct 2026 expected | gastric cancer | Second Affiliated Hospital of Nanchang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06774222 | Sep 2023 → Dec 2025 overdue | gastroesophageal adenocarcinoma | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05954429 | Jul 2023 → Dec 2026 expected | colorectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05571644 | Jul 2023 → Dec 2025 overdue | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06168786 | Jun 2023 → Feb 2026 overdue | colorectal cancer | Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT05555901 | Jun 2023 → Sep 2025 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05831891 | May 2023 → Oct 2027 expected | renal cell adenocarcinoma | RenJi Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06018714 | May 2023 → Aug 2024 overdue | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05941325 | Apr 2023 → Dec 2026 | sarcoma | Shanghai 6th People's Hospital | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05721651 | Apr 2023 → Mar 2025 | gastric cancer | Wu Jun | Unknown | No outcome recorded |
| Phase 2 | NCT05771181 | Mar 2023 → Dec 2025 overdue | colorectal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05747716 | Feb 2023 → Dec 2026 expected | colorectal cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06427005 | Feb 2023 → Aug 2025 | — | Meng Qiu | Unknown | No outcome recorded |
| Phase 2 | NCT07024537 | Jan 2023 → May 2025 | colorectal neoplasm | Meng Qiu | Completed | No outcome recorded |
| Phase 2 | NCT05659290 | Jan 2023 → Dec 2025 | colorectal cancer | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05795296 | Dec 2022 → Aug 2024 | gastric neoplasm | RenJi Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05643677 | Dec 2022 → Nov 2024 | gastric cancer | Fujian Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05634590 | Dec 2022 → Dec 2025 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05575635 | Nov 2022 → May 2024 | rectal cancer | Henan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05625737 | Sep 2022 → Dec 2024 | gastric neoplasm | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05763927 | Sep 2022 → Oct 2024 | rectal cancer | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05447715 | Aug 2022 → Dec 2024 | colorectal cancer | Weijian Guo | Unknown | No outcome recorded |
| Phase 2 | NCT05279677 | Aug 2022 → Oct 2023 | colorectal cancer | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT05435313 | Jul 2022 → Jan 2024 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05451719 | Jul 2022 → Jul 2024 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05177068 | May 2022 → Oct 2024 overdue | gastric cancer | Henan Cancer Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05241899 | May 2022 → May 2023 | gastric cancer | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 2 | NCT05636150 | Mar 2022 → Mar 2024 | esophageal squamous cell carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05292417 | Mar 2022 → Mar 2023 | colorectal carcinoma | The First Affiliated Hospital of Xiamen University | Unknown | No outcome recorded |
| Phase 2 | NCT05004831 | Mar 2022 → Sep 2023 | colorectal cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05406206 | Feb 2022 → Jul 2023 | colorectal carcinoma, metastasis from malignant tumor of colon | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04956146 | Feb 2022 → Sep 2023 | non-small cell lung carcinoma | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05257122 | Feb 2022 → Sep 2023 | — | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04866108 | Dec 2021 → Jun 2024 | colorectal cancer | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05971199 | Nov 2021 → Dec 2024 | hepatocellular carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05142631 | Nov 2021 → May 2023 | soft tissue sarcoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05122091 | Nov 2021 → Nov 2024 | gastric cancer, gastroesophageal cancer | Guangxi Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05168527 | Sep 2021 → Mar 2024 | malignant pancreatic neoplasm | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04948034 | Aug 2021 → Dec 2022 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04989855 | Aug 2021 → Aug 2022 | — | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05004441 | Jul 2021 → May 2023 | colorectal cancer | Zhou Fuxiang | Completed | No outcome recorded |
| Phase 2 | NCT04924179 | Jun 2021 → Dec 2022 | colorectal cancer | Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT04866862 | Apr 2021 → Jun 2024 | colorectal neoplasm | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT04716634 | Apr 2021 → Feb 2024 | cancer | BeiGene | Completed | No outcome recorded |
| Phase 2 | NCT04733963 | Mar 2021 → Jan 2023 | colorectal cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT04296019 | Feb 2021 → Jul 2023 | colorectal cancer | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05025631 | Nov 2020 → Oct 2022 | colorectal cancer | Zhen-Yu Ding | Completed | No outcome recorded |
| Phase 2 | NCT04582981 | Sep 2020 → Jun 2023 | colorectal carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04695470 | Sep 2020 → Dec 2021 | colorectal cancer | Aiping Zhou | Unknown | No outcome recorded |
| Phase 2 | NCT04483219 | Jul 2020 → Jul 2022 | colorectal adenocarcinoma | China Medical University, China | Unknown | No outcome recorded |
| Phase 2 | NCT04156958 | Dec 2019 → Sep 2021 | biliary tract cancer | Sichuan University | Unknown | No outcome recorded |
| Phase 2 | NCT04179084 | Aug 2019 → Mar 2020 | colorectal cancer | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03684967 | May 2018 → Sep 2019 | lung cancer | Hutchison Medipharma Limited | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02976116 | Dec 2016 → Jun 2019 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 2 | NCT02590965 | May 2014 → Aug 2015 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | Met primary |
| Phase 2/34 trials · 1 met primary | ||||||
| Phase 2/3 | NCT06977061 | Jun 2025 → Jun 2026 overdue | gastric neoplasm | Queling Liu | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06443671 | Jun 2024 → Jun 2026 overdue | rectal cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06441565 | May 2024 → Dec 2025 overdue | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05522231 | Oct 2022 → Jan 2025 overdue | renal cell carcinoma | Hutchmed | Active not recruiting | Met primary |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT07483684 | Mar 2026 → Aug 2027 expected | carcinoma | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07362836 | Jan 2026 → Dec 2028 expected | colorectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07270991 | Dec 2025 → Nov 2030 expected | gastroesophageal adenocarcinoma | Federation Francophone de Cancerologie Digestive | Recruiting | No outcome recorded |
| Phase 3 | NCT06584032 | Dec 2024 → Jan 2029 expected | endometrial cancer | Hutchmed | Recruiting | No outcome recorded |
| Phase 3 | NCT06199973 | Mar 2024 → Apr 2026 overdue | colorectal cancer | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05914610 | Sep 2023 → Jul 2025 overdue | gastric cancer | Fujian Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04322539 | Aug 2020 → Jul 2022 | colorectal cancer, metastatic malignant neoplasm in the colon | Hutchison Medipharma Limited | Completed | Met primary |
| Phase 3 | NCT04164199 | Dec 2019 → May 2026 | cancer | BeOne Medicines | Completed | No outcome recorded |
| Phase 3 | NCT03223376 | Oct 2017 → Sep 2022 | gastric cancer | Hutchison Medipharma Limited | Completed | Mixed |
| Phase 44 trials | ||||||
| Phase 4 | NCT07446465 | Mar 2026 → Jan 2027 expected | colorectal cancer | Ye Xu | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06562543 | Jan 2025 → Oct 2027 expected | colorectal cancer | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06118762 | Oct 2023 → Oct 2026 expected | colorectal cancer | The First Affiliated Hospital of Nanchang University | Recruiting | No outcome recorded |
| Phase 4 | NCT05661357 | Jan 2023 → Jan 2025 | colorectal cancer | Zhongnan Hospital | Unknown | No outcome recorded |
| Phase not applicable11 trials | ||||||
| — | NCT07552402 | Jun 2026 → Dec 2027 expected | gastroesophageal junction adenocarcinoma | Harbin Medical University | Recruiting | No outcome recorded |
| — | NCT07124858 | Mar 2026 → Mar 2031 expected | colorectal cancer | Federation Francophone de Cancerologie Digestive | Recruiting | No outcome recorded |
| — | NCT06985316 | May 2025 → Apr 2028 expected | colorectal cancer | Liu Huang | Not yet recruiting | No outcome recorded |
| — | NCT06553781 | Sep 2024 → Sep 2025 overdue | melanoma | Fudan University | Not yet recruiting | No outcome recorded |
| — | NCT06551207 | Aug 2024 → Dec 2026 expected | colorectal cancer | Liu Huang | Recruiting | No outcome recorded |
| — | NCT06613113 | Aug 2024 → Apr 2025 overdue | colorectal cancer | Ningbo Medical Center Lihuili Hospital | Recruiting | No outcome recorded |
| — | NCT06317298 | Feb 2024 → Aug 2025 | clear cell renal carcinoma | Peking University First Hospital | Unknown | No outcome recorded |
| — | NCT06199232 | Jan 2024 → Jun 2026 overdue | metastasis from malignant tumor of colon | Peking University | Active not recruiting | No outcome recorded |
| — | NCT06115733 | Dec 2023 → Dec 2026 expected | colorectal carcinoma | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| — | NCT06158919 | Nov 2023 → Nov 2024 overdue | gastroesophageal junction adenocarcinoma | Fudan University | Recruiting | No outcome recorded |
| — | NCT05928312 | Aug 2023 → Jun 2025 | colorectal cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 0 | NCT06347198 Background | Apr → Dec 2024 | colorectal cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 1/2 | NCT05867420 Background | Aug 2023 → Dec 2026 expected | cancer | AskGene Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05565417 Background | Nov 2022 → Jan 2026 overdue | Burkitt lymphoma, Hodgkins lymphoma, colorectal cancer, diffuse large B-cell lymphoma +8 | Immunitas Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05405595 Background | Jun 2022 → Oct 2026 expected | — | Adagene Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT07535632 Comparator | Jun 2026 → Jun 2028 expected | colorectal neoplasm | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07235293 Comparator | Jan → Sep 2026 overdue | colorectal cancer | Kahr Bio Australia Pty Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT07257653 Background | Oct 2025 → Dec 2026 expected | colorectal adenocarcinoma | Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT05511051 Background | Feb 2022 → Aug 2024 | colorectal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT02196688 Comparator | Apr 2014 → Apr 2015 | colorectal cancer | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 3 | NCT07384377 Comparator | Feb 2026 → Nov 2027 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06497985 Comparator | Dec 2024 → May 2028 expected | colorectal cancer | Chipscreen Biosciences, Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT02691299 Comparator | Dec 2015 → Sep 2018 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 3 | NCT02314819 Comparator | Dec 2014 → Jan 2017 | colorectal cancer | Hutchison Medipharma Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 64
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Hutchison Medipharma Limited | Regulatory HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma hutch-med.com ↗ |
| 2026-05-21 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and HUTCHMED Jointly Announce NMPA Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma innoventbio.com ↗ |
| 2026-04-17 | Immunitas Therapeutics | Results Immunitas Presents Phase 1/2a Data Highlighting Anti-Tumor Activity of Novel Immunotherapy IMT-009 at AACR 2026 Annual Meeting immunitastx.com ↗
IMT-009 was generally well tolerated as monotherapy and in combination with fruquintinib, demonstrating early signs of anti-tumor activity in heavily pretreated patients |
| 2026-04-13 | Immunitas Therapeutics | Results A First in Human, Dose Escalation and Biomarker Cohort Expansion of IMT-009 (anti CD161) in advanced cancer and Phase 1b combination with Fruquintinib in Microsatellite Stable Colorectal Cancer immunitastx.com ↗
Confirmed MSS CRC partial responders with both mono- and combination therapy |
| 2025-12-08 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China hutch-med.com ↗
ELUNATE® (fruquintinib) is included for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, in combination with TYVYT® (sintilimab injection). |
| 2025-10-13 | Hutchison Medipharma Limited | Results HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress hutch-med.com ↗
The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). |
| 2025-06-05 | Hutchison Medipharma Limited | Regulatory HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma hutch-med.com ↗
has been accepted for review by the China National Medical Products Administration (“NMPA”). |
| 2025-06-05 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Renal Cell Carcinoma innoventbio.com ↗ |
| 2025-03-19 | Hutchison Medipharma Limited | Results HUTCHMED and Innovent Jointly Announce that the FRUSICA-2 Phase II/III Study of Fruquintinib and Sintilimab Combination Has Met its Primary Endpoint in Advanced Renal Cell Carcinoma in China hutch-med.com ↗
The combination of fruquintinib and sintilimab received conditional approval from the China National Medical Products Administration (“NMPA”) for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705). |
| 2025-03-19 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and HUTCHMED Jointly Announce that the FRUSICA-2 Phase 2/3 Study of Sintilimab and Fruquintinib Combination Has Met Its Primary Endpoint in Advanced Renal Cell Carcinoma in China innoventbio.com ↗
In addition to the primary endpoint PFS, the combination also demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). |
| 2024-12-04 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial Cancer innoventbio.com ↗
This approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China and marks the eighth approved indication for TYVYT® (sintilimab injection). |
| 2024-12-03 | Hutchison Medipharma Limited | Regulatory HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Cancer hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China |
| 2024-09-24 | Takeda | Regulatory Takeda Receives Approval for FRUZAQLA (fruquintinib) in Japan for the Treatment of Unresectable Advanced or Recurrent Colorectal Cancer takeda.com ↗ |
| 2024-09-24 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Japan Approval for FRUZAQLA® (fruquintinib) Received by Takeda hutch-med.com ↗
FRUZAQLA® has been approved for the treatment of advanced or recurrent CRC that is neither curable nor resectable and that has progressed after chemotherapy. |
| 2024-08-30 | Hutchison Medipharma Limited | Regulatory HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer in China hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward. |
| 2024-06-22 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces European Commission Approval for FRUZAQLA® (fruquintinib) Received by Takeda hutch-med.com ↗ |
| 2024-06-21 | Takeda | Regulatory Takeda Receives Approval from European Commission for FRUZAQLA in Previously Treated Metastatic Colorectal Cancer takeda.com ↗ |
| 2024-06-03 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Publication of Phase III FRUTIGA Results in Nature Medicine hutch-med.com ↗ |
| 2024-05-24 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting hutch-med.com ↗
The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. |
| 2024-04-26 | Takeda | Regulatory Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). |
| 2024-04-26 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda hutch-med.com ↗ |
| 2024-04-02 | Hutchison Medipharma Limited | Regulatory HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status hutch-med.com ↗
NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 |
| 2024-04-02 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status innoventbio.com ↗ |
| 2024-02-07 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in Second-Line Gastric Cancer at ASCO Plenary Series Session hutch-med.com ↗
Median PFS for patients who received fruquintinib plus paclitaxel was 5.6 months, compared to 2.7 months for those who received paclitaxel monotherapy, a statistically significant improvement (stratified hazard ratio [“HR”] = 0.569; p < 0.0001). |
| 2024-01-30 | Hutchison Medipharma Limited | Regulatory HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer hutch-med.com ↗
HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). |
| 2023-12-13 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement. |
| 2023-11-09 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer hutch-med.com ↗
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. |
| 2023-11-08 | Takeda | Regulatory Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer takeda.com ↗ |
| 2023-09-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Submission of New Drug Application for Fruquintinib for Previously Treated Metastatic Colorectal Cancer in Japan hutch-med.com ↗ |
| 2023-07-20 | Hutchison Medipharma Limited | Regulatory HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial Cancer, and Completes Enrollment of Registration Study hutch-med.com ↗ |
| 2023-06-16 | Hutchison Medipharma Limited | Results HUTCHMED and Takeda Announce Publication of Phase III FRESCO-2 Results in The Lancet hutch-med.com ↗
The FRESCO-2 study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in overall survival (“OS”) and progression-free survival (“PFS”), respectively. |
| 2023-06-15 | Takeda | Results Takeda and HUTCHMED Announce Publication of Phase 3 FRESCO-2 Results in The Lancet takeda.com ↗
The FRESCO-2 study met its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), respectively. |
| 2023-06-15 | Takeda | Regulatory Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). |
| 2023-06-15 | Hutchison Medipharma Limited | Regulatory Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency hutch-med.com ↗ |
| 2023-05-26 | Hutchison Medipharma Limited | Regulatory Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review hutch-med.com ↗ |
| 2023-05-26 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Presentations at the 2023 ASCO Annual Meeting hutch-med.com ↗
In subgroup analyses by prior lines of therapies up to six or more and by prior treatment with approved agents, fruquintinib improved overall survival (“OS”) and progression free survival (“PFS”) for all subgroups and prior therapies |
| 2023-05-25 | Takeda | Regulatory Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review takeda.com ↗
Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). |
| 2023-04-18 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer hutch-med.com ↗
The NMPA acceptance of our NDA for fruquintinib is a positive step towards addressing the significant unmet medical need for gastric cancer patients. |
| 2023-03-31 | Hutchison Medipharma Limited | Regulatory HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that it completed the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer (“CRC”). |
| 2022-12-19 | Hutchison Medipharma Limited | Regulatory HUTCHMED Initiates Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Colorectal Cancer hutch-med.com ↗ |
| 2022-11-14 | Hutchison Medipharma Limited | Results HUTCHMED Announces Positive Topline Result in Fruquintinib Phase III FRUTIGA Study in Second-Line Gastric Cancer in China hutch-med.com ↗
The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival (“PFS”), which is clinically meaningful. |
| 2022-09-08 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Phase III FRESCO-2 MRCT Data Summary of Fruquintinib in Refractory Metastatic Colorectal Cancer from the Upcoming ESMO 2022 Presentation hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces summary results of the 691-patient, multi-regional clinical trial (“MRCT”) of fruquintinib. |
| 2022-08-23 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Fruquintinib MRCT FRESCO-2 Data to be Presented at the Upcoming ESMO Congress 2022 hutch-med.com ↗
Trial met primary endpoint of overall survival and all secondary endpoints |
| 2022-08-08 | Hutchison Medipharma Limited | Results HUTCHMED Announces that Fruquintinib Global Phase III FRESCO-2 Study Has Met Its Primary Endpoint in Metastatic Colorectal Cancer hutch-med.com ↗ |
| 2022-03-01 | Hutchison Medipharma Limited | Regulatory HUTCHMED Receives Approval to Commercialize ELUNATE® in Macau hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has received approval to market fruquintinib (ELUNATE® in China), a selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, in the Macau Special Administrative Region. |
| 2021-12-03 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Agreement with NHSA for Continued Inclusion of ELUNATE® and Addition of SULANDA® in the National Reimbursement Drug List in China hutch-med.com ↗
We welcome the addition of SULANDA® into the NRDL, along with the renewal of ELUNATE®. |
| 2021-06-07 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and HUTCHMED Release Phase 1b preliminary Results of TYVYT® (Sintilimab Injection) plus Fruquintinib as a Third Line Treatment for Advanced Colorectal Cancer at ASCO Annual Meeting 2021 innoventbio.com ↗
The objective response rate (ORR) was 22.7% (10/44, 95% CI: 11.5-37.8%) with 27.3% (6/22, 95% CI: 10.7-50.2%) in the 5mg-intermittent group and 18.2% (4/22, 95% CI: 5.2-40.3%) in the 3mg-continuous group. |
| 2020-06-18 | Hutchison Medipharma Limited | Regulatory Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer hutch-med.com ↗ |
| 2019-11-28 | Hutchison Medipharma Limited | Regulatory Chi-Med’s Elunate® (Fruquintinib Capsules) Included in the National Reimbursement Drug List in China hutch-med.com ↗
Elunate® (fruquintinib capsules), its national class 1 targeted anticancer drug for the treatment of patients with advanced colorectal cancer (“CRC”), has been included in the updated National Reimbursement Drug List (“NRDL”) released by China’s National Healthcare Security Administration (“NHSA”). |
| 2018-11-16 | Hutchison Medipharma Limited | Results Chi-Med Announces Phase III FALUCA Trial Results for Fruquintinib in Third-Line, Advanced Non-Small Cell Lung Cancer in China hutch-med.com ↗
The trial did not meet the primary endpoint to demonstrate a statistically significant increase in overall survival (“OS”) compared to placebo. |
| 2018-09-05 | Hutchison Medipharma Limited | Regulatory Chi-Med Announces the Approval of Fruquintinib Capsules for Previously Treated Colorectal Cancer in China hutch-med.com ↗ |
| 2018-06-04 | Hutchison Medipharma Limited | Results Chi-Med Presents Further Fruquintinib FRESCO Trial Data at ASCO 2018 Annual Meeting hutch-med.com ↗
Subgroup analysis showed consistent survival benefit across all key subgroups |
| 2017-10-16 | Hutchison Medipharma Limited | Results Chi-Med Reports Preliminary Phase II data on Fruquintinib Combination in First-Line Lung Cancer hutch-med.com ↗
Preliminary data from this Phase II proof-of-concept trial, the first study assessing combining fruquintinib with another tyrosine kinase inhibitor, demonstrated promising efficacy and an acceptable safety profile. |
| 2017-09-29 | Hutchison Medipharma Limited | Results Chi-Med Highlights Oral Presentations at CSCO Annual Meeting hutch-med.com ↗
Significant improvements in OS and PFS were demonstrated irrespective of whether patients had received prior anti-VEGF therapy or anti-epidermal growth factor receptor (“EGFR”) therapy. |
| 2017-06-12 | Hutchison Medipharma Limited | Regulatory Chi-Med Submits New Drug Application to CFDA for Fruquintinib in Advanced Colorectal Cancer hutch-med.com ↗
Application accepted by CFDA for technical review by the Center for Drug Evaluation |
| 2017-06-05 | Hutchison Medipharma Limited | Results Chi-Med Highlights Phase III Fruquintinib Data in Oral Presentation at ASCO hutch-med.com ↗
“Data from this 416-patient trial showed that treatment with fruquintinib resulted in statistically significant and clinically meaningful survival benefits in colorectal cancer patients who failed two previous lines of systemic therapy,” |
| 2017-05-18 | Hutchison Medipharma Limited | Results Chi-Med Presents Clinical Data at ASCO 2017 Annual Meeting hutch-med.com ↗
Primary endpoint median overall survival was 9.30 months for fruquintinib versus 6.57 months in the control group, with a hazard ratio of 0.65 and p< 0.001. |
| 2017-04-07 | Hutchison Medipharma Limited | Results Chi-Med Presented Pre-clinical Data for Fruquintinib and Sulfatinib at the American Association for Cancer Research Annual Meeting 2017 hutch-med.com ↗
In NSCLC xenograft models with EGFR activation such as activating mutations, gene amplification or protein overexpression, fruquintinib plus an EGFR tyrosine kinase inhibitor such as gefitinib or theliatinib (HMPL-309) was found to be more efficacious than either monotherapy. |
| 2017-03-03 | Hutchison Medipharma Limited | Results Chi-Med Announces Positive Top-Line Results for FRESCO, its Phase III Pivotal Registration Trial of Fruquintinib in Patients with Locally Advanced or Metastatic Colorectal Cancer hutch-med.com ↗
The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care (“BSC”) as compared to patients treated with placebo plus BSC. |
| 2015-09-02 | Hutchison Medipharma Limited | Results Second proof-of-concept trial of fruquintinib achieves its primary endpoint hutch-med.com ↗
The top-line results demonstrated that the trial clearly succeeded in meeting the primary efficacy endpoint of progression free survival (“PFS”). |
| 2015-05-13 | Hutchison Medipharma Limited | Results Positive fruquintinib proof-of-concept study results trigger payments from Lilly hutch-med.com ↗
The payments have been triggered by the first positive proof-of-concept (“POC”) study of fruquintinib in the treatment of patients with metastatic colorectal cancer (“mCRC”) in China. |
| 2015-03-30 | Hutchison Medipharma Limited | Results The first proof-of-concept trial of fruquintinib achieves primary efficacy endpoint hutch-med.com ↗
The top-line results demonstrated that the trial clearly succeeded in meeting the primary efficacy endpoint of progression free survival. |
| 2013-04-08 | Hutchison Medipharma Limited | Results Presentations of Fruquintinib Phase I Clinical Data and Volitinib Preclinical Data at the 2013 AACR Annual Meeting hutch-med.com ↗
One presentation will report on the final results of the Fruquintinib Phase I study, which demonstrated favourable clinical safety profile, pharmacokinetic properties and preliminary clinical efficacy. |
| 2011-02-01 | Hutchison Medipharma Limited | Regulatory Fruquintinib receives SFDA IND approval Starts Phase I Clinical Trial for the treatment of cancer hutch-med.com ↗
This follows approval from the State Food and Drug Administration (“SFDA”) in China. |
All press releases naming this drug 101 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 101 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 182 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fruquintinib | “Phase II Clinical Study of Digoxin Combined With Fruquintinib and Tislelizumab in Patients With Advanced Primary Colorectal Cancer Who Failed Standard Therapy” NCT07025850 ↗177“Fruquintinib (Group B, KRAS/NRAS/BRAF/EGFR mutation type and wide type but treated with cetuximab in last 3 months): 3 mg/d, d3-23, then suspend for 1w.” NCT06199232 ↗ “Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection are administered until disease progression or toxicity intolerable.” NCT07392346 ↗ “Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory colorectal cancer.” NCT05842525 ↗ “All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle” NCT07024537 ↗ “combination therapy with IDOV-SAFE + Toripalimab + Fruquintinib after progression on IDOV-SAFETM monotherapy.” NCT06380309 ↗ “Multimodal ablation combined with cadonilimab and fruquintinib” NCT06889610 ↗ “Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w.” NCT04483219 ↗ “Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w” NCT06195670 ↗ “Fruquintinib:5mg,po.qd,Day1\~21, repeat every 28 days” NCT04446091 ↗ “Fuquinitinib capsule (Aiutec, Fruquintinib)” NCT06078670 ↗ |
| Known as | Aiutec | “Fuquinitinib capsule (Aiutec, Fruquintinib)” NCT06078670 ↗ |
| Known as | ELUNATE | “Fruquintinib (Elunate®) is an orally available, potent and highly selective small molecule inhibitor of VEGFR-1, -2 and -3 that was discovered and developed by Hutchison...” PMID 30357594 ↗ Nov 20182“Fruquintinib (trade name: Elunate) is a novel small molecule tyrosine kinase inhibitor.” NCT04156958 ↗ “Fruquintinib (ELUNATE®) is a novel kinase inhibitor” PMID 36623495 ↗ Jan 2023 |
| Known as | Fruquintinib Capsules | “Fruquintinib Capsules：4 mg / day, orally once daily on days 1-14 in 21-day cycles.” NCT06706895 ↗ |
| Known as | Fruquintinib+ chemotherapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05555901 ↗ |
| Known as | Fruzaqla | ChEMBL registry synonym — accepted as the source's own label CHEMBL4303214 ↗ |
| Known as | HMPL-013 | “whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).” NCT06584032 ↗2“Study of Fruquintinib (HMPL-013) in High Risk Patients With Advanced NSCLC” NCT03684967 ↗ “Fruquintinib (HMPL-013) is a novel oral small molecule compound” PMID 27299749 ↗ Jun 2016 |
| Action | Inhibit | “selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3” NCT01645215 ↗ |
| Modality | Small molecule | “novel oral small molecule” NCT01645215 ↗ |
| Route | Oral | “continuous oral dosing” NCT01645215 ↗ |