HUTCHMED Receives Breakthrough Therapy Designation in China for HMPL-523 for Treatment of Primary Immune Thrombocytopenia
January 12 2022 - 6:00AM
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that the Center for Drug Evaluation of China’s
National Medical Products Administration (“NMPA”) has granted
Breakthrough Therapy Designation (“BTD”) to HMPL-523, a novel,
investigational spleen tyrosine kinase (“Syk”) inhibitor, for the
treatment of chronic adult primary immune thrombocytopenia (“ITP”)
patients who have received at least one prior therapy.
NMPA grants BTD to new drugs that treat
life-threatening diseases or serious conditions for which there are
no effective treatment options, and where clinical evidence
demonstrates significant advantages over existing therapies. Drug
candidates with BTD may be considered for conditional approval and
priority review when submitting a New Drug Application (NDA).
Christian Hogg, Chief Executive Officer of
HUTCHMED, said, “ITP is an autoimmune bleeding disorder that can
often be serious and can have a significant, multifaceted impact on
patients’ health and quality of life. The granting of BTD to
HMPL-523 in ITP highlights the unmet need in this treatment setting
and the promising clinical value of this novel oral Syk inhibitor.
With this designation, we are hopeful that can accelerate the
development of HMPL-523 in China.”
The BTD is supported by the encouraging results
from the Phase Ib study of HMPL-523, which were presented at the
63rd American Society of Hematology (ASH) Annual Meeting in
December 2021. The data also supported the initiation of a Phase
III trial, ESLIM-01, in China of HMPL-523 in adult patients with
ITP in October 2021. Approximately 180 patients are expected to be
enrolled. Additional details may be found at clinicaltrials.gov,
using identifier NCT05029635.
About HMPL-523
HMPL-523 is a novel, investigational, selective
small molecule inhibitor for oral administration targeting spleen
tyrosine kinase, also known as Syk. Syk is a major component in
B-cell receptor signaling and is an established target for the
treatment of multiple subtypes of B-cell lymphomas and autoimmune
disorders.
HUTCHMED currently retains all rights to
HMPL-523 worldwide. The ESLIM-01 Phase III trial is underway to
evaluate the efficacy and safety of HMPL-523 in treating adult
patients with primary ITP, an autoimmune disorder that can lead to
increased risk of bleeding. Additional details may be found at
clinicaltrials.gov, using identifier NCT05029635. HMPL-523 is also
being studied in indolent non-Hodgkin’s lymphoma and multiple
subtypes of B-cell malignancies in China (NCT02857998), the U.S.
and Europe (NCT03779113).
About ITP and Syk
ITP is an autoimmune disorder characterized by
immunologic destruction of platelets and decreased platelet
production. Patients with ITP exhibit symptoms of petechiae,
purpura, and gastrointestinal and/or urinary mucosal tract
bleeding.1 ITP is also associated with fatigue (reported in up
to 39% of adults with ITP) and impaired quality of life, across
domains of emotional, functional and reproductive health, and work
or social life.2-6 The incidence of primary ITP in adults is
estimated to be 3.3 per 100,000 adults per year with a prevalence
of 9.5 per 100,000 adults.7
Adult ITP is a heterogeneous disease that can
persist for years, even with best available care, and treatments
are infrequently curative. Despite the availability of several
treatments with differing mechanisms of action, chronicity of
disease continues to be a problem. Many patients develop resistance
to treatment and thereby are prone to relapse.8 Thus, there
remains a significant population of patients who have limited
sensitivity to currently available agents and are in need of new
treatments.
As platelet destruction in ITP is mediated by
Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition
represents a promising approach to the management of ITP.9
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. It has more than
4,500 personnel across all its companies, at the center of which is
a team of over 1,400 in oncology/immunology. Since inception it
has advanced 11 cancer drug candidates from in-house discovery into
clinical studies around the world, with its first three oncology
drugs now approved and marketed in China. 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 HMPL-523 for patients with ITP and other
indications, its expectations as to whether any studies on HMPL-523
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 and the 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 HMPL-523, including as a combination therapy, to meet
the primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions and to gain commercial
acceptance after obtaining regulatory approval; the potential
market of HMPL-523 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.
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 – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile)
HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley, Panmure Gordon
(UK) Limited |
+44 (20) 7886 2500 |
___________________________________________________
- Zufferey A, Kapur R, Semple JW.
Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia
(ITP). J. Clin. Med. 2017, 6(2), 16.
- McMillan R, Bussel JB, et al.
Self-reported health-related quality of life in adults with chronic
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Feb;83(2):150-4.
- Snyder CF, Mathias SD, Cella D, et
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Opin. 2008 Oct;24(10):2767-76.
- Doobaree IU, Nandigam R, Bennett D,
et al. Thromboembolism in adults with primary immune
thrombocytopenia: a systematic literature review and meta-analysis.
Eur J Haematol. 2016 Oct;97(4):321-30.
- Sarpatwari A, Bennett D, Logie JW,
et al. Thromboembolic events among adult patients with primary
immune thrombocytopenia in the United Kingdom General Practice
Research Database. Haematologica. 2010 Jul;95(7):1167-75.
- Sarpatwari A, Watson S, Erqou S, et
al. Health-related lifestyle in adults and children with primary
immune thrombocytopenia (ITP). Br J Haematol. 2010
Oct;151(2):189-91.
- Lambert MP, Gernsheimer TB.
Clinical updates in adult immune thrombocytopenia. Blood. 2017 May
25;129(21):2829-2835.
- Provan D, Arnold DM, Bussel JB, et
al. Updated international consensus report on the investigation and
management of primary immune thrombocytopenia. Blood Adv.
2019;3(22):3780-3817.
- Crowley MT, Costello PS,
Fitzer-Attas CJ et al. A critical role for Syk in signal
transduction and phagocytosis mediated by Fcγ receptors on
macrophages. J. Exp. Med. 186(7), 1027–1039 (1997).
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