RCS - Hutchmed China Ltd - Sovleplenib NDA Granted Priority Review in China

HUTCHMED (China)Announcement

11/01/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240111:nRSK2785Za&default-theme=true

RNS Number : 2785Z  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 (https://www.hutch-med.com/) ")
(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
(https://www.hutch-med.com/sovleplenib-eslim-01-met-primary-endpoint/) 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
(https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(23)00034-0/ppt)
.

 

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
(https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(23)00034-0/ppt)
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 (https://clinicaltrials.gov/ct2/show/NCT05535933) ) and
indolent non-Hodgkin's lymphoma (NCT03779113
(https://clinicaltrials.gov/ct2/show/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  (#_edn1) ITP is also
associated with fatigue (reported in up to 39% of adults with ITP) and
impaired quality of life. 2  (#_edn2) (, 3  (#_edn3) , 4  (#_edn4) , 5 
(#_edn5) , 6  (#_edn6) ) 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  (#_edn7) 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  (#_edn8)

 

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  (#_edn9) 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  (#_edn10)

 

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 (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
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
                                                                   (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

 1  (#_ednref1) Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic
Mechanisms in Immune Thrombocytopenia (ITP). J. Clin. Med. 2017, 6(2), 16.

 2  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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  (#_ednref5) 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  (#_ednref6) 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  (#_ednref7) Lambert MP, Gernsheimer TB. Clinical updates in adult immune
thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.

 8  (#_ednref8) Clarivate Landscape & Forecast for Immune Thrombocytopenic
Purpura, 2018.

 9  (#_ednref9) 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  (#_ednref10) 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).

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRABDGDBRBBDGSG