RCS - Hutchmed China Ltd - Breakthrough Therapy Designation for Amdizalisib

HUTCHMED (China)Announcement

13/09/2021 07:00

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RNS Number : 5354L  Hutchmed (China) Limited  13 September 2021

Press Release

 

HUTCHMED Receives Breakthrough Therapy Designation in China for Amdizalisib (HMPL-689) for Treatment of Relapsed or Refractory Follicular Lymphoma

 

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, September 13, 2021:
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 amdizalisib (HMPL-689), a
highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or
refractory follicular lymphoma ("FL"), a subtype of non-Hodgkin's lymphoma
("NHL").

 

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). This indicates
that the development and review of amdizalisib for relapsed or refractory FL
may be expedited, to address patients' unmet needs more quickly.

 

Christian Hogg, CEO of HUTCHMED, said, "The granting of BTD to amdizalisib by
the NMPA underscores the promising clinical value of this highly selective and
potent PI3Kδ inhibitor. There is a clear need for new therapies in this
treatment setting, particularly with regard to specific toxicities and
suboptimal efficacy with existing treatments across different lymphoma
subtypes. We look forward to important clinical data on amdizalisib being
presented at the ESMO Congress next week and are continuing to accelerate
global development of this novel therapy."

 

Updated preliminary results from the ongoing Phase Ib expansion study in China
will be presented as a Proffered Paper
(https://www.hutch-med.com/esmo-2021-highlights/) at the 2021 ESMO (European
Society for Medical Oncology) Congress on September 20, 2021. To date,
amdizalisib has been shown to be well tolerated, exhibiting dose-proportional
pharmacokinetics ("PK"), a manageable toxicity profile, and single-agent
clinical activity in relapsed/refractory B-cell lymphoma patients. Additional
details may be found at clinicaltrials.gov, using identifier NCT03128164
(https://www.clinicaltrials.gov/ct2/show/NCT03128164) .

 

HUTCHMED has initiated an extensive, globally-focused clinical development
pathway for amdizalisib. In April 2021, HUTCHMED initiated
(https://www.hutch-med.com/hutchmed-initiates-phase-ii-registration-study-of-hmpl-689-in-patients-with-fl-and-mzl-in-china/)
a Phase II registration study in China for amdizalisib in approximately 100
patients with relapsed or refractory FL and approximately 80 patients with
marginal zone lymphoma ("MZL"). The trial is being conducted in over 35 sites
in China. Additional details may be found at clinicaltrials.gov, using
identifier NCT04849351 (https://clinicaltrials.gov/ct2/show/NCT04849351) .

 

Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S.
and Europe in patients with relapsed or refractory NHL (NCT03786926
(https://clinicaltrials.gov/ct2/show/NCT03786926) ).

 

 

About PI3Kδ and NHL

 

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the
activation of several important signaling proteins. Upon an antigen binding to
B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling
cascade. The abnormal activation of B-cell receptor signaling is closely
related to the development of B-cell type hematological cancers, which
represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered
a promising target for drugs that aim to treat certain hematologic cancers.

 

FL accounts for approximately 17% of NHL. In 2020, there were an estimated
16,000 and 13,000 new cases of FL in China and the U.S., respectively 1 
(#_edn1) (, 2  (#_edn2) , 3  (#_edn3) ). Patients with relapsed or refractory
FL do not have curative treatment options and have a high unmet need for
optimal therapeutic options.

 

 

About Amdizalisib

 

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor
targeting the isoform PI3Kδ. Amdizalisib's PK properties are favorable with
good oral absorption, moderate tissue distribution and low clearance in
preclinical PK studies, suggesting a low risk of drug accumulation and
drug-to-drug interaction. Because of its high target selectivity and optimal
PK profile, amdizalisib has the potential to demonstrate an optimal
benefit-risk profile in this class.

 

HUTCHMED currently retains all rights to amdizalisib worldwide.

 

 

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. A dedicated
organization of over 1,400 personnel has advanced eleven cancer drug
candidates from in-house discovery into clinical studies around the world,
with its first three oncology drugs now approved. 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 amdizalisib for patients with FL, MZL and NHL, the
further clinical development for amdizalisib, its expectations as to whether
such studies 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, 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 amdizalisib, including as a combination therapy, to meet the
primary or secondary endpoint of a study, to obtain regulatory approval in
different jurisdictions, to gain commercial acceptance after obtaining
regulatory approval, the potential market of amdizalisib 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 (mailto: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 (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                        +852 9850 5033 (Mobile) / +852 9783 6894 (Mobile)

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

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

Panmure Gordon (UK) Limited

 

 1  (#_ednref1) Source: NCCN(®) - https://www.nccn.org (https://www.nccn.org)

 2  (#_ednref2) Source: SEER -
https://seer.cancer.gov/statfacts/html/follicular.html
(https://seer.cancer.gov/statfacts/html/follicular.html)

 3  (#_ednref3) Source: GLOBOCAN https://gco.iarc.fr/ (https://gco.iarc.fr/)

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