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07-Sep-2021

HUTCHMED Highlights Clinical Data to be Presented at the Upcoming 2021 ESMO Virtual Conference

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 7, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that new analyses and updates on the ongoing studies of amdizalisib (PI3Kδ inhibitor HMPL-689), savolitinib (ORPATHYS® in China) and fruquintinib (ELUNATE® in China) will be presented at the upcoming 2021 European Society for Medical Oncology (“ESMO”) Virtual Congress taking place on September 16-21, 2021.

AMDIZALISIB (also known as HMPL-689)

Title:

A phase Ib study result of HMPL-689, a PI3Kδ inhibitor, in Chinese patients with relapsed/refractory lymphoma

Lead Author:

Junning Cao, MD, Fudan University Shanghai Cancer Center

Session:

Proffered Paper  – Haematological Malignancies

Presentation Number:

833O

Date & Time:

Monday, September 20, 2021 2:10 pm CEST

Location:

Channel 3

 

 

SAVOLITINIB

 

Title:

ORCHARD osimertinib + savolitinib interim analysis: A biomarker-directed phase II platform study in patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on first-line (1L) osimertinib

Lead Author:

Helena Yu, MD, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College

Session:

ePoster

Presentation Number:

1239P

Date available:

Monday, September 13, 2021

 

 

 

 

FRUQUINTINIB

 

Title:

An open-label, phase Ib/II study to evaluate the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced triple negative breast cancer

Lead Author:

Debu Tripathy, MD, The University of Texas MD Anderson Cancer Center

Session:

ePoster

Presentation Number:

337TiP

Date available:

Monday, September 13, 2021

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetics (“PK”) properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In addition to the currently Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL).

HUTCHMED currently retains all rights to amdizalisib worldwide.

About Savolitinib (ORPATHYS® in China)

Savolitinib is an oral, potent, and highly selective mesenchymal epithelial transition receptor (MET) tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.

Savolitinib is marketed in China under the brand name ORPATHYS® for the treatment of patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.  It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.

In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib will be recognized by AstraZeneca.

About Fruquintinib (ELUNATE® in China)

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 HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) 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 1,400 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

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Last Updated: 07-Sep-2021