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
50x109/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 FcγR-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 Fcγ receptors on
macrophages. J. Exp. Med. 186(7), 1027–1039 (1997).
HUTCHMED China (NASDAQ:HCM)
Historical Stock Chart
From May 2024 to Jun 2024
HUTCHMED China (NASDAQ:HCM)
Historical Stock Chart
From Jun 2023 to Jun 2024