RCS - Hutchmed China Ltd - NMPA Conditional Approval for TAZVERIK®

HUTCHMED (China)Announcement

21/03/2025 10:00

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RNS Number : 6800B  Hutchmed (China) Limited  21 March 2025

Press Release

 

HUTCHMED Announces NMPA Conditional Approval for TAZVERIK(®) (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma

 

- First and only EZH2 inhibitor approved by the NMPA -

-HUTCHMED's fourth product, and its first approval in hematological
malignancies -

Hong Kong, Shanghai & Florham Park, NJ - Friday, March 21, 2025: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that the New Drug Application ("NDA") for
TAZVERIK(®) (tazemetostat) has been granted conditional approval in China for
the treatment of adult patients with relapsed or refractory ("R/R") follicular
lymphoma ("FL") with EZH2 mutation who have received at least two prior
systemic therapies.  This approval follows the priority review status by the
National Medical Products Administration ("NMPA") and marks the first
nationwide regulatory approval for TAZVERIK(®) in China.

 

The conditional approval by the NMPA was supported by results from a
multicenter, open-label, Phase II bridging study in China, and clinical
studies conducted by Epizyme, Inc. ("Epizyme"), an Ipsen company, outside
China. The primary objective of the bridging study is to evaluate the
objective response rate ("ORR") of TAZVERIK(®) for the treatment of patients
with R/R FL whose disease harbor EZH2 mutations. The secondary objectives
included duration of response ("DoR"), progression-free survival (PFS), and
overall survival (OS) of TAZVERIK(®) for the treatment of R/R FL patients, as
well as to evaluate the safety and pharmacokinetics. Additional details can be
found at clinicaltrials.gov, using identifier NCT05467943
(https://clinicaltrials.gov/ct2/show/NCT05467943) .

 

"This approval represents a significant advancement in the management of this
challenging disease. The majority of FL patients experience multiple relapses
over their lifetime, posing substantial treatment difficulties and often
leading to poor outcomes," said Dr Junning Cao of Fudan University Cancer
Center and the lead principal investigator of the bridging study.
"TAZVERIK(®) has demonstrated promising efficacy in patients harboring EZH2
mutation in clinical trials. We are eager to provide this transformational
epigenetic therapy to patients in China who have long sought new effective
treatment options."

 

"We are thrilled to be able to bring this innovative EZH2 inhibitor to
patients in China. This approval highlights our dedication to addressing unmet
medical needs not only through our internal pipeline, but also through
partnering," said Dr Michael Shi, Head of R&D and Chief Medical Officer of
HUTCHMED. "It also marks our first approval in hematological malignancies,
unveiling a new chapter for HUTCHMED as we extend our footprint into this
disease area. As we move forward, we are dedicated to making this product
available to R/R FL patients as soon as possible and will continue striving to
make a meaningful impact on the lives of more patients suffering from
devastating diseases."

 

TAZVERIK(®) is a first-in-class methyltransferase inhibitor of EZH2 developed
by Epizyme. It is approved by the US Food and Drug Administration ("FDA") for
the treatment of certain patients with R/R FL and certain patients with
advanced epithelioid sarcoma ("ES") under the FDA accelerated approval
program. It is also approved by the Japan Ministry of Health, Labour and
Welfare (MHLW) for certain patients with R/R FL. In 2021, HUTCHMED and Epizyme
entered a strategic partnership. HUTCHMED is responsible for the research,
development, manufacturing and commercialization of TAZVERIK(®) in China
Mainland, Hong Kong, Macau and Taiwan. Epizyme will be the Marketing
Authorization Holder of TAZVERIK(®) in China.

 

TAZVERIK(®) was approved for use in the Hainan Boao Lecheng International
Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, under the
Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain
patients with ES and FL consistent with the label as approved by the FDA.
TAZVERIK(®) was approved in Macau in March 2023 and in Hong Kong in May 2024.

 

The ongoing SYMPHONY-1 study will serve as the confirmatory trial to validate
the clinical benefits of TAZVERIK(®). SYMPHONY-1 is an international,
multicenter, randomized, double-blind, active-controlled, 3-stage,
biomarker-enriched, confirmatory Phase Ib/III study, which is designed to
evaluate the safety and efficacy of TAZVERIK(®) in combination with rituximab
and lenalidomide (R²) in patients with R/R FL after at least one prior line
of therapy (NCT04224493 (https://clinicaltrials.gov/ct2/show/NCT04224493) ).
Epizyme is the sponsor of SYMPHONY-1 and HUTCHMED is leading the study in
China.

About Follicular Lymphoma

FL is the second most common subtype of non-Hodgkin's lymphoma ("NHL"), making
up 20-30% of all NHL. In 2022, there were an estimated 81,000 and 78,000 new
cases of NHL in China and the US, respectively. 1 (,) 2 (,) 3 

 

About Tazemetostat approval in the United States and Japan

Tazemetostat 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 ES not eligible for complete resection.

·  Adult patients with R/R FL 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 R/R FL who have no satisfactory alternative treatment
options.

 

These indications are approved under accelerated approval by the US FDA based
on ORR and DoR. Continued approval for these indications may be contingent
upon verification and description of clinical benefit in confirmatory trials.

 

The most common (≥20%) adverse reactions in patients with ES are pain,
fatigue, nausea, decreased appetite, vomiting and constipation. The most
common (≥20%) adverse reactions in patients with FL are fatigue, upper
respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

 

Please see the US Full Prescribing Information
(https://d2rkmuse97gwnh.cloudfront.net/a88aa6d6-3ca0-4362-a711-d53c45ae33ff/522a2033-f01b-422d-81b6-78692eb7a6da/522a2033-f01b-422d-81b6-78692eb7a6da_source__v.pdf)
for TAZVERIK(®) (tazemetostat).

 

TAZVERIK(®) is approved in Japan with the indication of relapsed or
refractory EZH2 gene mutation-positive FL (only when standard treatment is not
applicable).

 

TAZVERIK(®) is commercialized by Epizyme in the US and by Eisai in Japan.

 

TAZVERIK(®) is a registered trademark of Epizyme Inc., an Ipsen company.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery and global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. Since inception it has
focused on bringing drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the first of
which is also approved around the world including in the US, Europe and Japan.
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 US 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 tazemetostat for the treatment of patients with
relapsed or refractory follicular lymphoma and the further clinical
development of tazemetostat in this and other indications. Forward‑looking
statements involve risks and uncertainties. Such risks and uncertainties
include, among other things, assumptions regarding the sufficiency of clinical
data to support NDA approval of tazemetostat for the treatment of patients
with follicular lymphoma in China and other jurisdictions, the safety profile
of tazemetostat, HUTCHMED's ability to fund, implement and complete its
further clinical development and commercialization plans for tazemetostat, and
the timing of these events. 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 US 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.

Medical Information

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS
 Investor Enquiries                                   +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                               +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                      Nominated Advisor and Joint Broker
 Atholl Tweedie / Freddy Crossley / Rupert Dearden    +44 20 7886 2500

 HSBC                                                 Joint Broker
 Simon Alexander / Alina Vaskina / Arnav Kapoor       +44 20 7991 8888

 Cavendish                                            Joint Broker
 Geoff Nash / Nigel Birks                             +44 20 7220 0500

 

 1     NCCN Guidelines for Patients: Follicular Lymphoma.
https://www.nccn.org/patients/guidelines/content/PDF/nhl-follicular-patient.pdf
(https://www.nccn.org/patients/guidelines/content/PDF/nhl-follicular-patient.pdf)
. Accessed February 17, 2025.

 2     SEER Cancer Stat Facts: Follicular Lymphoma. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/follicular.html
(https://seer.cancer.gov/statfacts/html/follicular.html) . Accessed February
17, 2025

 3     The Global Cancer Observatory (GLOBOCAN), Cancer Today | IARC.
https://gco.iarc.who.int/today/en/dataviz/bars?cancers=34
(https://gco.iarc.who.int/today/en/dataviz/bars?cancers=34) . Accessed
February 17, 2025.

 

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