RCS - Hutchmed China Ltd - TAZVERIK® Approved in Hainan Pilot Zone

HUTCHMED (China)Announcement

01/06/2022 09:30

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RNS Number : 5461N  Hutchmed (China) Limited  01 June 2022

HUTCHMED Announces TAZVERIK(®) Approved to be Used in Hainan Pilot Zone in China

 

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, June 1, 2022: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that TAZVERIK(®) (tazemetostat) has been approved by
the Health Commission and Medical Products Administration of Hainan Province
to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone
("Hainan Pilot Zone"), under the Clinically Urgently Needed Imported Drugs
scheme, for the treatment of certain patients with epithelioid sarcoma ("ES")
and follicular lymphoma ("FL") consistent with the label as approved by the
U.S. Food and Drug Administration ("FDA"). Launched in 2013 and located in
China, the Hainan Pilot Zone is a destination for international medical
tourism and global hub for scientific innovation, welcoming 83,900 medical
tourists in 2020, according to official data.

 

TAZVERIK(®) is a methyltransferase inhibitor of EZH2 1  developed by Epizyme,
Inc. ("Epizyme"). It is approved by the FDA for the treatment of certain
patients with ES and certain patients with FL under FDA accelerated approval
granted in January and June 2020, respectively.

 

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of
HUTCHMED, said: "The approval of TAZVERIK(®) in the Hainan Pilot Zone allows
patients to gain early access to this first-in-class EZH2 inhibitor in China,
as part of our commitment to bringing innovative medicines to people in need.
In addition to its use in the Hainan Pilot Zone, we also plan to initiate
further registration-enabling studies in China under the terms of our
agreement with Epizyme to facilitate wider and easier patient access."

 

In August 2021, HUTCHMED entered into a strategic collaboration with Epizyme
to research, develop, manufacture and commercialize TAZVERIK(®) in China,
Hong Kong, Macau and Taiwan.

 

About FL and ES

Follicular lymphoma (FL) is a subtype of non-Hodgkin's lymphoma ("NHL"). 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.  2 (, 3 , 4 )

 

Epithelioid sarcoma (ES) is a rare, slow-growing type of soft tissue cancer.
Radical tumor resection is the primary treatment for patients with ES.
However, ES is known for its high propensity for locoregional recurrence and
distant metastases. The survival of patients with ES is often unsatisfactory
with very limited treatment options. 5 

 

About TAZVERIK(®) (tazemetostat)

TAZVERIK(®) is a methyltransferase inhibitor indicated in the United States
for the treatment of:

 

·      Adults and pediatric patients aged 16 years and older with
metastatic or locally advanced epithelioid sarcoma not eligible for complete
resection.

 

·      Adult patients with relapsed or refractory follicular lymphoma
whose tumors are positive for an EZH2 mutation as detected by an FDA-approved
test and who have received at least two prior systemic therapies.

 

·      Adult patients with relapsed or refractory follicular lymphoma
who have no satisfactory alternative treatment options.

 

These indications are approved under accelerated approval by the U.S. FDA
based on overall response rate and duration of response. Continued approval
for these indications may be contingent upon verification and description of
clinical benefit in confirmatory trials.

 

View the U.S. Full Prescribing Information here: www.tazverik.com
(http://www.tazverik.com)

 

 

About Tazemetostat Clinical Development in China

HUTCHMED and Epizyme are developing tazemetostat in various hematological and
solid tumors in Greater China, with HUTCHMED leading the China portion of
Epizyme's SYMPHONY-1 study. HUTCHMED and Epizyme also intend to conduct
additional global studies jointly.

 

SYMPHONY-1 (EZH-302) is an international, multicenter, randomized,
double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory
Phase 1b/3 study, which is designed to evaluate the safety and efficacy of
tazemetostat in combination with R(2) in patients with relapsed or refractory
FL after at least one prior line of therapy (clinicaltrials.gov identifier:
NCT04224493 (https://clinicaltrials.gov/ct2/show/NCT04224493) ).

 

We intend to initiate a bridging study in FL to support registration of
tazemetostat in China, as well as several combination studies of tazemetostat
with HUTCHMED assets.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage,
biopharma-ceutical company. It is committed to the discovery and global
develop-ment and commercial-ization of targeted therapies and immuno-therapies
for the treatment of cancer and immuno-logical diseases. It has more than
4,600 personnel across all its companies, at the center of which is a team of
about 1,700 in oncology/immunology. Since inception it has advanced 12 cancer
drug candidates from in-house discovery into clinical studies around the
world, with its first three oncology drugs now approved and marketed in China.
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/) .

 

Cautionary Note on 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 TAZVERIK(®) for the treatment of patients with ES or
FL, the further clinical development of TAZVERIK(®) in this and other
indications, risks associated with the use of TAZVERIK(®) in the Hainan Pilot
Zone, including that it could be discontinued in the future for a variety of
reasons, the risk that ongoing or future clinical trials conducted by HUTCHMED
for TAZVERIK(®) may not meet their primary or secondary endpoints or will
warrant meetings with regulatory authorities, submissions for regulatory
approval or review by governmental authorities under the accelerated approval
process and 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 regulatory approvals, including accelerated approval, to
conduct trials or to market products (including to continue offering
TAZVERIK(®) in the Hainan Pilot Zone or elsewhere in China, Hong Kong, Macau
and Taiwan), its expectations that preclinical studies or earlier clinical
studies are predictive of the results of future trials, such as the ongoing
confirmatory trials, the safety profile of TAZVERIK(®), the potential for
TAZVERIK(®) to become a new standard of care for ES or FL patients,
HUTCHMED's and Epizyme's ability to implement and complete its further
clinical development plans for TAZVERIK(®), the potential commercial launch
of TAZVERIK(®) in China and other jurisdictions in the approved indications,
the sufficiency of each company's cash resources to fund its foreseeable and
unforeseeable operating expenses and capital expenditure requirements, the
timing of these events, and the impact of the COVID-19 pandemic on HUTCHMED's
business, results of operations and financial condition and on general
economic, regulatory and political conditions. In addition, as certain studies
rely on the use of other drug candidates as combination therapeutics with
TAZVERIK(®), such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and regulatory approval of such drug candidates.
Existing and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date hereof.
HUTCHMED anticipates that subsequent events and developments may cause its
views to change; however, HUTCHMED does not undertake any 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. For a further
discussion of these and other risks, see HUTCHMED's filings with the U.S.
Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong
Kong Limited.

 

CONTACTS
 Investor Enquiries
 Mark Lee, Senior Vice President    +852 2121 8200
 Annie Cheng, Vice President        +1 (973) 567 3786

 Media Enquiries
 Americas - Brad Miles,             +1 (917) 570 7340 (Mobile)

Solebury Trout
bmiles@troutgroup.com
 Europe - Ben Atwell / Alex Shaw,   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                    +44 7779 545 055 (Mobile)
                                    HUTCHMED@fticonsulting.com
 Asia - Zhou Yi,                    +852 9783 6894 (Mobile)

Brunswick                         HUTCHMED@brunswickgroup.com

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

Panmure Gordon (UK) Limited

 

 1  EZH2 = Enhancer of Zeste Homolog 2

 2  Source: NCCN(®) - https://www.nccn.org

 3  Source: SEER - https://seer.cancer.gov/statfacts/html/follicular.html

 4  Source: GLOBOCAN https://gco.iarc.fr/

 5  Sobanko JF, Meijer L, Nigra TP. Epithelioid sarcoma: a review and update.
J Clin Aesthet Dermatol. 2009;2(5):49-54.

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