TIDMHCM

Hutchmed (China) Limited

20 May 2021

Press Release

HUTCHMED Highlights Clinical Data to be Presented at the Upcoming ASCO21 Virtual Scientific Program

- HUTCHMED will review these highlights as part of its company update audio call and webcast on Wednesday, May 26 at 9 a.m. EDT to discuss data disclosures, its PD-1/L1 combination study strategy and provide a corporate update -

Hong Kong, Shanghai & Florham Park, NJ - Thursday, May 20, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) today announces that new analyses and updates on the ongoing studies of savolitinib, surufatinib, fruquintinib and HMPL-306 will be presented at the upcoming ASCO21 Virtual Scientific Program, taking place on June 4-8, 2021.

Aspects of these clinical data disclosures, alongside its PD-1/L1 combination study strategy and corporate update will be discussed part of the previously announced call. For more details, please visit: https://www.hutch-med.com/event/.

SAVOLITINIB

 
Title:             Clinical activity of durvalumab and savolitinib in 
                    MET-driven, metastatic papillary renal cancer 
Lead Author:       Cristina Suárez, MD, Hospital Univ. Vall D Hebron 
                    General 
Session:           Poster Discussion Session: Genitourinary Cancer-Kidney 
                    and Bladder 
Abstract Number:   4511 
 

SURUFATINIB

 
Title:             Interim analysis results of surufatinib in U.S. patients 
                    with neuroendocrine tumors (NETs). 
Lead Author        Scott Paulson, MD, Baylor Sammons Cancer Center 
Session:           Poster Session: Gastrointestinal Cancer-Gastroesophageal, 
                    Pancreatic, and Hepatobiliary 
Abstract Number:   4114 
 
Title:             Surufatinib in combination with toripalimab in patients 
                    with advanced neuroendocrine carcinoma: results from 
                    a multicenter, open-label, single-arm, phase II trial 
Lead Author        Lin Shen, MD, Peking University Cancer Hospital & 
                    Institute 
Session:           Online publication only 
Number:            e16199 
 
Title:             Phase II trial of surufatinib plus toripalimab for 
                    disease progression after first-line chemotherapy 
                    with platinum and fluoropyrimidine in advanced gastric 
                    or gastroesophageal junction adenocarcinoma 
Lead Author        Lin Shen, MD, Peking University Cancer Hospital & 
                    Institute 
Session:           Online publication only 
Number:            e16040 
 
Title:             A single-arm, multi-center, open-label phase 2 trial 
                    of surufatinib in patients with unresectable or metastatic 
                    biliary tract cancer. 
Lead Author        Yuxian Bai, MD, PhD, Harbin Medical University Cancer 
                    Hospital 
Session:           Online publication only 
Number:            e16123 
 
Title:             Subgroup analysis by Ki-67 and baseline CgA of the 
                    randomized, placebo-controlled phase 3 study of surufatinib 
                    in advanced well-differentiated pancreatic neuroendocrine 
                    tumors (SANET-p) 
Lead Author         Xianjun Yu, MD, Fudan University Shanghai Cancer 
                     Center 
Session:           Poster Session: Gastrointestinal Cancer-Gastroesophageal, 
                    Pancreatic, and Hepatobiliary 
Abstract Number:   4111 
 
Title:             An open-label phase 1b/2 study of surufatinib in 
                    combination with tislelizumab in subjects with advanced 
                    solid tumors 
Lead Author        Arvind Dasari, MD, MS, MD Anderson Cancer Center 
Session:           Poster Session: Developmental Therapeutics-Immunotherapy 
Abstract Number:   TPS2677 
 

FRUQUINTINIB

 
Title:             Preliminary results of a phase 1b study of fruquintinib 
                    plus sintilimab in advanced colorectal cancer 
Lead Author        Ye Guo, MD, Shanghai East Hospital 
Session:           Poster Discussion Session: Gastrointestinal Cancer-Colorectal 
                    and Anal 
Abstract Number:   2514 
 
Title:             A phase Ib trial of assessing the safety and preliminary 
                    efficacy of a combination therapy of Geptanolimab 
                    (GB 226) plus Fruquintinib in patients with metastatic 
                    colorectal cancer (mCRC) 
Lead Author        Yanzhi Cui, MD, Tumour Institute, Fourth Hospital 
                    of Hebei Medical University 
Session:           Online publication only 
Number:            e15551 
 

HMPL-306

 
Title:            A multicenter open-label phase 1 study evaluating 
                   the safety and tolerability of HMPL-306 in patients 
                   with locally advanced or metastatic solid tumors 
                   with IDH mutations. 
Lead Author       Filip Janku, MD, MD Anderson Cancer Center 
Session:          Poster Session: Developmental Therapeutics-Molecularly 
                   Targeted Agents and Tumor Biology 
Abstract Number:  TPS3159 
 

About Savolitinib

Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,100 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

In 2011, HUTCHMED entered into a global licensing and joint development and commercialization agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for savolitinib. Savolitinib's global development plan includes non-small cell lung cancer (NSCLC) and kidney cancer, and additional MET-driven tumors are being explored.

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, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFRs -1, -2 and -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 also be highly suitable for combinations with other anti-cancer therapies.

HUTCHMED retains all rights to fruquintinib outside of China. In China, HUTCHMED is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.

About HMPL-306

HMPL-306 is HUTCHMED's ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.

HUTCHMED currently retains all rights to HMPL-306 worldwide.

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,200 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first two oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "pipeline," "could," "potential," "first-in-class," "designed to," "objective," "guidance," "pursue," or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular,

management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; the impact of the COVID-19 pandemic or other health crises in China or globally on general economic, regulatory and political conditions; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission and on AIM. HUTCHMED is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

CONTACTS

 
Investor Enquiries 
  Mark Lee, Senior Vice President                            +852 2121 8200 
  Annie Cheng, Vice President                                +1 (973) 567 3786 
 
Media Enquiries 
  Americas - Brad Miles, Solebury Trout                      +1 (917) 570 7340 (Mobile) 
                                                              bmiles@troutgroup.com 
  Europe - Ben Atwell / Alex Shaw, FTI Consulting            +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 
                                                             545 055 (Mobile) 
                                                             HUTCHMED@fticonsulting.com 
  Asia - Joseph Chi Lo / Zhou Yi, Brunswick                  +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile) 
                                                              HUTCHMED@brunswickgroup.com 
 
Nominated Advisor 
  Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) 
   Limited                                                   +44 (20) 7886 2500 
 

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END

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