HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma

About PI3Kd and NHL
PI3Kd (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kd can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kd is considered a promising target for drugs that aim to treat certain hematologic cancers. FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively[i],[ii],[iii]. Patients with relapsed or refractory FL do not have curative treatment options and have a high unmet need for optimal therapeutic options.About Amdizalisib
Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kd. Amdizalisib?s 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 currently retains all rights to amdizalisib worldwide.About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, 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. 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 reflect HUTCHMED?s current expectations regarding future events, including its expectations regarding the therapeutic potential of amdizalisib for patients with FL, MZL and NHL, the further clinical development for amdizalisib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study?s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of amdizalisib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of amdizalisib for a targeted indication, the sufficiency of funding and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED?s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. [i]?Source: NCCN????https://www.nccn.org [ii]?Source: SEER ??https://seer.cancer.gov/statfacts/html/follicular.html [iii]?Source: GLOBOCAN?https://gco.iarc.fr/CONTACTS
Investor Enquiries |
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Mark Lee, Senior Vice President | +852 2121 8200 |
Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
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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 | |
Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
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Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited | +44 (20) 7886 2500 |