TIDMHCM
Hutchmed (China) Limited
11 January 2024
Press Release
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for
the Treatment of Primary Immune Thrombocytopenia with Priority
Review Status
- NDA accepted and granted Priority Review following its
Breakthrough Therapy designation granted in January 2022 -
- NDA is supported by data from successful Phase III ESLIM-01
trial in patients with adult primary immune thrombocytopenia who
have received at least one previous therapy -
Hong Kong, Shanghai & Florham Park, NJ - Thursday, January
11, 2024: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that the New Drug Application ("NDA") for
sovleplenib for the treatment of adult patients with primary immune
thrombocytopenia ("ITP") has been accepted for review and granted
priority review by the China National Medical Products
Administration ("NMPA"). Sovleplenib is a novel, selective, oral
inhibitor targeting spleen tyrosine kinase ("Syk"), being developed
for the treatment of hematological malignancies and immune
diseases.
The NDA is supported by data from ESLIM-01, a randomized,
double-blinded, placebo-controlled Phase III trial in China of
sovleplenib in 188 adult patients with primary ITP who have
received at least one prior line of standard therapy. In August
2023, HUTCHMED announced that the trial had met its primary
endpoint of demonstrating a clinically meaningful and a
statistically significant increase in durable response rate in
patients treated with sovleplenib as compared to patients treated
with placebo. Secondary endpoints including response rate and
safety were also met. Full results will be published in due course.
Results from the proof of concept study that led to the ESLIM-01
study were published in The Lancet Haematology .
The NMPA granted Breakthrough Therapy designation ("BTD") to
sovleplenib for the indication studied in ESLIM-01 in January 2022.
The NMPA granted this designation to sovleplenib as a new drug that
could treat a serious condition for which there are no effective
treatment options, and where clinical evidence demonstrates
significant advantages over existing therapies.
"We are pleased to have initiated the rolling submission of an
NDA for sovleplenib in China as we look to bring this novel
treatment to ITP patients," said Dr. Weiguo Su, Executive Director,
Chief Executive Officer and Chief Scientific Officer of HUTCHMED.
"Our submission includes data from the successful Phase III
ESLIM-01 trial in China which demonstrated a durable response rate
of sovleplenib for patients. There is a significant need for new
therapies in adult primary ITP which can significantly impair the
quality of life for patients."
About Sovleplenib
Sovleplenib is a novel, selective inhibitor of Syk for once
daily oral administration. Syk is a major component in B-cell
receptor and FcR signaling and is an established target for the
treatment of multiple subtypes of B-cell lymphomas and autoimmune
disorders.
Results from the Phase I/II study in China study published in
The Lancet Haematology showed a rapid and durable increase in
platelet counts in previously treated patients with ITP. Among the
patients who received the recommend Phase II dose of 300mg once
daily ("RP2D"), 40% of patients experienced durable response, as
defined by platelet count equal to or exceeding 50x10(9) /L in four
out of six visits during week 14 to 24 of the study. All RP2D
patients had been previously treated with glucocorticoid steroid,
and 80% were previously treated with thrombopoietin or
thrombopoietin receptor agonists. Among the patients who received
treatment at all doses through week 24 of the study,
treatment-emergent adverse events ("TEAE") led to dose reduction or
interruption in 7% patients, and no dose discontinuation. No TEAEs
of grade 3 or above occurred in more than one patient through week
24 of the study.
Sovleplenib is currently under clinical investigation and its
safety and efficacy have not been evaluated by any regulatory
authority.
HUTCHMED currently retains all rights to sovleplenib worldwide.
In addition to ITP, sovleplenib is also being studied in warm
antibody autoimmune hemolytic anemia (NCT05535933) and indolent
non-Hodgkin's lymphoma (NCT03779113).
About ITP
ITP is an autoimmune disorder characterized by immunologic
destruction of platelets and decreased platelet production.
Patients with ITP are at increased risk of excessive bleeding and
bruising. [1] ITP is also associated with fatigue (reported in up
to 39% of adults with ITP) and impaired quality of life. [2](, [3]
, [4] , [5] , [6]) The incidence of primary ITP in adults is
3.3/100,000 adults per year with a prevalence of 9.5 per 100,000
adults. [7] Based on this prevalence rate, approximately 110,000
patients are estimated to be living with primary ITP in China, in
addition to 56,000 patients in the U.S., Germany, France, Italy,
Spain, UK, and Japan. It has been estimated that as many as 145,000
patients are living with chronic ITP in major pharmaceutical
markets excluding China. [8]
Adult ITP is a heterogeneous disease that can persist for years,
even with best available care, and treatments are infrequently
curative. Despite 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. [9] 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 Fc<GAMMA>R-bound platelets, Syk inhibition
represents a promising approach to management of ITP. [10]
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. It has approximately 5,000 personnel across
all its companies, at the center of which is a team of about 1,800
in oncology/immunology. Since inception, HUTCHMED has focused on
bringing cancer drug candidates from in-house discovery to patients
around the world, with its first three oncology medicines now
approved marketed in China, the first of which is also marketed in
the U.S. 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 submission of a
NDA for sovleplenib for the treatment of ITP with the NMPA and the
timing of such submission, therapeutic potential of sovleplenib for
the treatment of patients with ITP and the further development of
sovleplenib in this and other indications. Forward-looking
statements involve risks and uncertainties. Such risks and
uncertainties include, among other things, assumptions regarding
the timing and outcome of clinical studies and the sufficiency of
clinical data to support NDA approval of sovleplenib for the
treatment of patients with ITP or other indications in China or
other jurisdictions, its potential to gain approvals from
regulatory authorities on an expedited basis or at all, the safety
profile of sovleplenib, HUTCHMED's ability to fund, implement and
complete its further clinical development and commercialization
plans for sovleplenib, the timing of these events, and the impact
of COVID-19 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 +852 2121 8200 / ir@hutch-med.com
Media Enquiries
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
[1] Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic
Mechanisms in Immune Thrombocytopenia (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. Thromboembolism
in adults with primary immune thrombocytopenia: 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. Thromboembolic
events among adult patients with primary immune thrombocytopenia 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
thrombocytopenia (ITP). Br J Haematol. 2010 Oct;151(2):189-91.
[7] Lambert MP, Gernsheimer TB. Clinical updates in adult immune
thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.
[8] Clarivate Landscape & Forecast for Immune
Thrombocytopenic Purpura, 2018.
[9] 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.
[10] Crowley MT, Costello PS, Fitzer-Attas CJ et al. A critical
role for Syk in signal transduction and phagocytosis mediated by
Fc<GAMMA> receptors on macrophages. J. Exp. Med. 186(7),
1027-1039 (1997).
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