drugset
Drugs / Surufatinib
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Surufatinib

also known as Sulfatinib · HMPL-012 · Sulanda · Surufatinib hydrochloride

Small molecule targets CSF1R, FGFR1 via inhibition

Developed for
biliary tract cancer · neuroendocrine neoplasm · malignant pancreatic neoplasm · small cell lung carcinoma · non-small cell lung carcinoma · colorectal cancer · intrahepatic cholangiocarcinoma · gastric cancer
+44 more · neoplasm · neuroendocrine carcinoma · osteosarcoma · soft tissue sarcoma · esophageal squamous cell carcinoma · hepatocellular carcinoma · lung neuroendocrine neoplasm · ovarian cancer · pancreatic ductal adenocarcinoma · pancreatic exocrine neoplasm · pancreatic neuroendocrine tumor · primary peritoneal carcinoma · appendix carcinoma · bile duct adenocarcinoma · cancer · cancer of unknown primary site · cancer-related condition · carcinoma · carcinoma of the ampulla of vater · colorectal neoplasm · differentiated thyroid carcinoma · digestive system carcinoma · Ewing sarcoma · female breast carcinoma · gallbladder cancer · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · head and neck squamous cell carcinoma · lymphoma · metastatic malignant neoplasm · metastatic neoplasm · nasopharyngeal carcinoma · neoplastic disease or syndrome · pancreas disorder · rhabdomyosarcoma · salivary gland cancer · salivary gland carcinoma · sarcoma · small intestine adenocarcinoma · small intestine neuroendocrine neoplasm · thyroid cancer · thyroid gland carcinoma · thyroid gland undifferentiated (anaplastic) carcinoma · triple-negative breast carcinoma
Investigated by
Hutchison Medipharma Limited · Sun Yat-sen University · Fudan University · Hutchmed · Fujian Cancer Hospital · Tianjin Medical University Cancer Institute and Hospital
+40 more · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Peking University · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai Zhongshan Hospital · BeiGene · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Qilu Hospital of Shandong University · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Zhejiang Cancer Hospital · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Anhui Provincial Cancer Hospital · Bai-Rong Xia · Beijing Chest Hospital · Changhai Hospital · China Medical University, China · Chinese PLA General Hospital · Chonnam National University · Dai, Guanghai · Hubei Cancer Hospital · Huihua Xiong · Hunan Cancer Hospital · Innovent Biologics (Suzhou) Co. Ltd. · Jiangsu Cancer Institute & Hospital · Li Zhang, MD · National Cancer Center, China · Peking Union Medical College Hospital · Peking University People's Hospital · RenJi Hospital · Rui-hua Xu, MD, PhD · Ruijin Hospital · Shanghai Changzheng Hospital · Shanghai Chest Hospital · Shanghai Jiao Tong University Affiliated Sixth People's Hospital · The Affiliated Hospital of Xuzhou Medical University · The First Affiliated Hospital of Zhengzhou University · Tongji Hospital · Wuhan TongJi Hospital · Zhejiang University · Zhongnan Hospital

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed non-functional pancreatic neuroendocrine tumor 1 milestone
Filed China (NMPA) — non-functional pancreatic neuroendocrine tumor 2019-11-11

“its New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (“NET”) has been accepted for review” hutch-med.com ↗

“Following positive interim analysis and early termination of SANET-p Phase III, an NDA for pancreatic NET has been submitted in China” hutch-med.com ↗

“A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET has been submitted to the NMPA.” hutch-med.com ↗

“Supported by the positive SANET-ep Phase III and submitted in late 2019, the NMPA NDA review process is on-track” hutch-med.com ↗
Filed pancreatic neuroendocrine tumor 3 milestones
Filed EU (EMA) — pancreatic neuroendocrine tumor 2021-07-16

“today announces that the European Medicines Agency (“EMA”) has validated and accepted its marketing authorization application (“MAA”) for surufatinib” hutch-med.com ↗

“Fully submitted EMA MAA21 for surufatinib, which was validated and accepted in July 2021” hutch-med.com ↗

“Fully submitted EMA MAA for surufatinib, which was validated and accepted in July 2021” hutch-med.com ↗
Filed US (FDA) — pancreatic neuroendocrine tumor 2021-04-30

“FDA has accepted its filing of the New Drug Application (“NDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”).” hutch-med.com ↗
Filed US (FDA) — pancreatic neuroendocrine tumor 2020-12-29

“initiated the filing of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”)” hutch-med.com ↗

“Completed submission of U.S. FDA NDA for surufatinib, which was accepted in June 2021” hutch-med.com ↗

“Completed submission of U.S. FDA NDA for surufatinib, which was accepted in June 2021” hutch-med.com ↗

Trials 103 · started per year

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2010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03627520 Apr → Jul 2018 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 111 trials
Phase 1 NCT04755075 Feb → Oct 2021 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04755088 Feb → Aug 2021 impaired renal function disease Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04372394 Aug → Oct 2020 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04510649 Jul → Sep 2020 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04372407 Jul → Sep 2020 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT04427774 Jun 2020 → Feb 2021 — Innovent Biologics (Suzhou) Co. Ltd. Terminated No outcome recorded
Phase 1 NCT03879057 Dec 2018 → Dec 2020 neoplasm Peking University Unknown No outcome recorded
Phase 1 NCT03483259 Apr → May 2018 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT02320409 Dec 2014 → Jan 2015 — Hutchison Medipharma Limited Completed No outcome recorded
Phase 1 NCT02267967 Oct 2014 → Aug 2017 neuroendocrine neoplasm Hutchison Medipharma Limited Completed No outcome recorded
Phase 1/216 trials
Phase 1/2 NCT06255262 Feb 2024 → Oct 2025 biliary tract cancer China Medical University, China Unknown No outcome recorded
Phase 1/2 NCT05832892 Nov 2023 → Nov 2024 neoplastic disease or syndrome Shanghai Zhongshan Hospital Unknown No outcome recorded
Phase 1/2 NCT06038461 Sep 2023 → Sep 2026 overdue neuroendocrine neoplasm Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting No outcome recorded
Phase 1/2 NCT05747729 Jun 2023 → Oct 2026 expected neuroendocrine carcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 1/2 NCT05882630 Jun 2023 → Jun 2025 small cell lung carcinoma Fujian Cancer Hospital Unknown No outcome recorded
Phase 1/2 NCT05746728 Apr 2023 → Aug 2024 triple-negative breast carcinoma Huihua Xiong Unknown No outcome recorded
Phase 1/2 NCT05590572 Jan 2023 → Dec 2026 expected osteosarcoma Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 1/2 NCT05494580 Sep 2022 → Jun 2024 fallopian tube carcinosarcoma, ovarian carcinoma, primary peritoneal carcinoma Sun Yat-sen University Completed No outcome recorded
Phase 1/2 NCT05839275 Aug 2022 → Jul 2024 overdue soft tissue sarcoma Fudan University Recruiting No outcome recorded
Phase 1/2 NCT05093322 Nov 2021 → Apr 2023 Ewing sarcoma, lymphoma, osteosarcoma, rhabdomyosarcoma Hutchmed Completed No outcome recorded
Phase 263 trials
Phase 2 NCT07833241 Sep 2026 → Sep 2028 expected pancreatic exocrine neoplasm Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07609121 Jun 2026 → May 2029 expected non-small cell lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07469956 Mar 2026 → Jan 2028 expected pancreas disorder Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07279532 Jan 2026 → Dec 2029 expected neuroendocrine neoplasm Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 2 NCT07103395 Jan 2026 → Dec 2029 expected non-small cell lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07156019 Oct 2025 → Dec 2026 expected neuroendocrine carcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 2 NCT07357623 Sep 2025 → Sep 2027 expected lung neuroendocrine neoplasm Shanghai Chest Hospital Recruiting No outcome recorded
Phase 2 NCT07086469 Jul 2025 → Jul 2029 expected esophageal squamous cell carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07086456 Jul 2025 → Jul 2029 expected non-small cell lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT06654947 Jan 2025 → Dec 2026 expected biliary tract cancer Fujian Cancer Hospital Not yet recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT06361888 May 2024 → May 2028 expected malignant pancreatic neoplasm Hutchmed Recruiting No outcome recorded
Phase 2/3 NCT03873532 Jul 2018 → Jun 2021 biliary tract cancer Hutchison Medipharma Limited Unknown No outcome recorded
Phase 33 trials · 2 met primary
Phase 3 NCT07436741 Mar 2026 → Sep 2028 expected malignant pancreatic neoplasm Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 3 NCT02589821 Dec 2015 → Nov 2019 pancreatic neuroendocrine tumor Hutchison Medipharma Limited Completed Met primary
Phase 3 NCT02588170 Dec 2015 → Mar 2019 neuroendocrine neoplasm Hutchison Medipharma Limited Completed Met primary
Phase 41 trial
Phase 4 NCT07272512 Nov 2025 → Nov 2027 expected neuroendocrine neoplasm Shanghai Zhongshan Hospital Recruiting No outcome recorded
Phase not applicable5 trials
— NCT06313554 May 2024 overdue intrahepatic cholangiocarcinoma Fudan University Not yet recruiting No outcome recorded
— NCT06156332 Jan 2024 → Jan 2025 overdue neuroendocrine neoplasm Shanghai Changzheng Hospital Not yet recruiting No outcome recorded
— NCT06110650 Nov 2023 → Aug 2024 soft tissue sarcoma Fudan University Unknown No outcome recorded
— NCT05056116 Sep 2021 → Jun 2022 biliary tract cancer The Affiliated Hospital of Xuzhou Medical University Unknown No outcome recorded
— NCT05013515 Aug 2021 → Sep 2022 salivary gland carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Unknown No outcome recorded
Phase not stated1 trial
— NCT04814732 — neuroendocrine neoplasm Hutchmed No longer available No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT05015621 Comparator Sep 2021 → May 2025 neuroendocrine carcinoma Hutchison Medipharma Limited Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 26

DateIssuerRelease
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 ↗
SULANDA® (surufatinib) is renewed for the treatment of patients with unresectable; locally advanced or metastatic; progressive non-functional, well-differentiated (G1 or G2) pancreatic and non-pancreatic neuroendocrine tumors.
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.
2022-08-01 Hutchison Medipharma Limited Regulatory HUTCHMED Reports 2022 Interim Results and Provides Business Updates hutch-med.com ↗
While receiving a Complete Response Letter for surufatinib from the U.S. FDA7 earlier this year and our decision today to withdraw the EMA8 MAA9 are a disappointment, it has no impact on our global development strategy.
2022-05-02 Hutchison Medipharma Limited Regulatory HUTCHMED Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors hutch-med.com ↗
FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States (U.S.), does not support an approval in the U.S. at this time.
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®.
2021-09-29 Hutchison Medipharma Limited Results HUTCHMED Highlights Oral Presentations at 2021 Chinese Society of Clinical Oncology Annual Meeting hutch-med.com ↗
Median overall survival (“OS”), reported for the first time, was 10.3 months (95% CI: 9.1-not reached).
2021-07-16 Hutchison Medipharma Limited Regulatory HUTCHMED’s Marketing Authorization Application for Surufatinib Submitted and Validated by the European Medicines Agency hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the European Medicines Agency (“EMA”) has validated and accepted its marketing authorization application (“MAA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”).
2021-07-01 Hutchison Medipharma Limited Regulatory U.S. FDA Accepts Filing of HUTCHMED’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors hutch-med.com ↗
This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide.
2021-06-18 Hutchison Medipharma Limited Regulatory HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda® in China) for Advanced Pancreatic Neuroendocrine Tumors hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of advanced pancreatic neuroendocrine tumors (“pNETs”).
2021-05-03 Hutchison Medipharma Limited Regulatory HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors hutch-med.com ↗
2020-12-30 Hutchison Medipharma Limited Regulatory Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda® in China) for Non-Pancreatic Neuroendocrine Tumors hutch-med.com ↗
2020-12-29 Hutchison Medipharma Limited Regulatory Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors hutch-med.com ↗

All press releases naming this drug 50 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 104 sources stand behind the page.

FieldValueCited text
Known as Surufatinib “in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11” NCT04510649 ↗
97

“Consolidation therapy consists of iparomlimab and tuvonralimab, surufatinib and thymosin alpha 1, for a total duration of 1 year.” NCT07103395 ↗

“Surufatinib 200 mg orally once daily (po, qd) on days 1-14, administered concurrently with immunochemotherapy.” NCT07086469 ↗

“Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.” NCT06719700 ↗

“Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.” NCT06375642 ↗

“Surufatinib: 250 mg once daily, taken continuously.” NCT06437353 ↗

“Surufatinib” NCT06134193 ↗

NCT02589821 ↗

NCT07086456 ↗

NCT05652283 ↗

NCT06654947 ↗

Show 87 more sources
Known as HMPL-012 “Surufatinib (Sulanda, HMPL-012) is an oral small-molecule tyrosine kinase inhibitor that selectively targets VEGFR1-3, FGFR1 and CSF1R, exerting both anti-angiogenic and...” NCT07272512 ↗
2

“Surufatinib(HMPL-012)” NCT04734249 ↗

“Surufatinib(HMPL-012)” NCT04955886 ↗
Known as Sulanda “Surufatinib (Sulanda, HMPL-012) is an oral small-molecule tyrosine kinase inhibitor that selectively targets VEGFR1-3, FGFR1 and CSF1R, exerting both anti-angiogenic and...” NCT07272512 ↗
Known as Sulfatinib ClinicalTrials.gov intervention name — accepted as the source's own label NCT02133157 ↗
5

NCT02267967 ↗

NCT03483259 ↗

NCT03627520 ↗

NCT02320409 ↗

NCT05590572 ↗
Known as Surufatinib hydrochloride “This is a non-randomized, phase II, open label study of Surufatinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck.” NCT04910854 ↗
Action Inhibit “selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity” NCT02133157 ↗
Modality Small molecule “Sulfatinib (HMPL-012) is a novel oral small molecule” NCT02133157 ↗
Route Oral “Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day” NCT02133157 ↗
Target CSF1R “Surufatinib is a potent inhibitor of colony-stimulating factor 1 receptor（CSF-1R）, which shows a promising tumor inhibition effect on sarcoma.” NCT05926492 ↗