Chi-Med Highlights Clinical Data to be Presented at the Upcoming ESMO Virtual Congress 2020
Hong Kong, Shanghai, & Florham Park, NJ: Monday, August 24, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that new and updated analyses on the studies of surufatinib and fruquintinib will be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020, taking place on September 17-21, 2020.
Further details of the presentations are as follows:
SURUFATINIB
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Title: |
Surufatinib (S) for patients (Pts) with advanced pancreatic neuroendocrine tumors (SANET-p): a randomized, double-blind, placebo (P)-controlled Phase III trial (NCT02589821) |
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Lead Author: |
Jianming Xu, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA |
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Session: |
Proffered Paper - NETs |
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Abstract #: |
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Date & Time: |
Sunday, September 20, 2020 2:25 PM CEST |
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Room: |
Channel 3 |
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Title: |
Subgroup analysis by Ki-67 and primary tumor origins of the randomized, placebo-controlled phase 3 study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumors (SANET-ep) |
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Lead Author: |
Zhiwei Zhou, Director, Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Cancer Center |
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Session: |
e-Poster Display Session |
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Abstract #: |
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Date available: |
Thursday, September 17, 2020 |
FRUQUINTINIB
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Title: |
Phase (Ph) 1/1b Trial of Fruquintinib (Fru) in Patients (Pts) with Advanced Solid Tumors: Preliminary Results of the Dose Expansion (Exp) Cohort in Refractory Metastatic Colorectal Cancer (mCRC) |
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Lead Author: |
N. Arvind Dasari, Associate Professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center |
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Session: |
e-Poster Display Session |
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Abstract #: |
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Date available: |
Thursday, September 17, 2020 |
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.
A New Drug Application (“NDA”) for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (“NMPA”) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET has been submitted to the NMPA. We have completed a pre-NDA meeting in the U.S. and received scientific advice in Europe, regarding surufatinib’s respective paths to registration in both geographies. Chi-Med is planning a rolling NDA submission from late 2020 into early 2021 to the U.S. Food and Drug Administration (FDA), followed by a marketing authorization application (MAA) to the European Medicines Agency (EMA) in 2021. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.
Chi-Med currently retains all rights to surufatinib worldwide.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company (“Lilly”) in late November 2018 under the brand name Elunate®, for the treatment of patients with metastatic colorectal cancer (“CRC”). A Phase III registration study for CRC is being initiated in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China. Starting October 1, 2020, Chi-Med will be responsible, through its commercial team in oncology of over 320 staff, for the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing activities in China for Elunate®. Lilly and Chi-Med will continue to collaborate, as before, in the formulation and execution of national marketing strategy and events in China for Elunate®.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
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