TIDMHCM
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") (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 PI3K 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 PI3K 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 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.
HUTCHMED has initiated an extensive, globally-focused clinical
development pathway for amdizalisib. In April 2021, HUTCHMED
initiated 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.
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).
About PI3K and NHL
PI3K (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, PI3K 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, PI3K 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](, [2] , [3]) . 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 PI3K . 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 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 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
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile)
HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Source: NCCN(R) - https://www.nccn.org
[2] Source: SEER -
https://seer.cancer.gov/statfacts/html/follicular.html
[3] Source: GLOBOCAN https://gco.iarc.fr/
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