RCS - Hutchmed China Ltd - Breakthrough Therapy Designation for HMPL-523

HUTCHMED (China)Announcement

12/01/2022 11:00

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RNS Number : 2293Y  Hutchmed (China) Limited  12 January 2022

Press Release

 

HUTCHMED Receives Breakthrough Therapy Designation in China for HMPL-523 for Treatment of Primary Immune Thrombocytopenia

 

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, January 12, 2022:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(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 (https://www.hutch-med.com/hmpl-523-2021-ash/)
at the 63(rd) American Society of Hematology (ASH) Annual Meeting in December
2021. The data also supported the initiation
(https://www.hutch-med.com/eslim-01-phase-iii-trial-initiated/) 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
(https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/NCT05029635) . HMPL-523 is also being
studied in indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell
malignancies in China (NCT02857998
(https://clinicaltrials.gov/ct2/show/NCT02857998) ), the U.S. and Europe
(NCT03779113 (https://clinicaltrials.gov/ct2/show/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 treat-ments 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 treat-ment 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 (https://www.hutch-med.com/)
or follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

 

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
combina-tion 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,             +1 (917) 570 7340 (Mobile)

Solebury Trout                    bmiles@troutgroup.com (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)
                                    HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick

                                    HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,  +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

___________________________________________________

 

1.   Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic Mechanisms
in Immune Thrombo-cytopenia (ITP). J. Clin. Med. 2017, 6(2), 16.

2.   McMillan R, Bussel JB, et al. Self-reported health-related quality of
life in adults with chronic immune thrombocytopenic purpura. Am J Hematol.
2008 Feb;83(2):150-4.

3.   Snyder CF, Mathias SD, Cella D, et al. Health-related quality of life
of immune thrombocytopenic purpura patients: results from a web-based survey.
Curr Med Res Opin. 2008 Oct;24(10):2767-76.

4.   Doobaree IU, Nandigam R, Bennett D, et al. Thrombo-embolism in adults
with primary immune thrombo-cytopenia: a systematic literature review and
meta-analysis. Eur J Haematol. 2016 Oct;97(4):321-30.

5.   Sarpatwari A, Bennett D, Logie JW, et al. Thrombo-embolic events among
adult patients with primary immune thrombo-cytopenia in the United Kingdom
General Practice Research Database. Haematologica. 2010 Jul;95(7):1167-75.

6.   Sarpatwari A, Watson S, Erqou S, et al. Health-related lifestyle in
adults and children with primary immune thrombo-cytopenia (ITP). Br J
Haematol. 2010 Oct;151(2):189-91.

7.   Lambert MP, Gernsheimer TB. Clinical updates in adult immune
thrombo-cytopenia. Blood. 2017 May 25;129(21):2829-2835.

8.   Provan D, Arnold DM, Bussel JB, et al. Updated international consensus
report on the investigation and management of primary immune
thrombo-cytopenia. Blood Adv. 2019;3(22):3780-3817.

9.   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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