REG - Hutchmed China Ltd - Update on Licensed Oncology Product in China

HUTCHMED (China)Announcement

09/03/2026 09:30

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RNS Number : 8622V  Hutchmed (China) Limited  09 March 2026

HUTCHMED Announces Update on Licensed Oncology Product TAZVERIK(®) in China

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, March 9, 2026: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) " or the "Company")
(Nasdaq/AIM:HCM; HKEX:13) today announces an update regarding TAZVERIK(®)
(tazemetostat), an oncology therapy licensed from Epizyme, Inc. ("Epizyme"),
an Ipsen ("Ipsen") company, in China. Epizyme is the Marketing Authorization
Holder of TAZVERIK(®) in the Chinese mainland, for which HUTCHMED Limited (a
subsidiary of the Company) acts as the domestic agent/licensee. Ipsen has
informed HUTCHMED that it is voluntarily withdrawing TAZVERIK(®) in the US.
As a result, steps have been taken to initiate the market withdrawal and
product recall in China. Consequently, HUTCHMED Limited has initiated a
withdrawal and product recall from the Chinese mainland, Hong Kong and Macau,
and is discontinuing all active tazemetostat clinical trials. Existing
patients should consult their treating physicians immediately to discuss their
treatment options.

 

Ipsen is the sponsor of the ongoing Phase Ib/III SYMPHONY-1 trial (evaluating
tazemetostat in combination with lenalidomide plus rituximab ("R²") vs R² in
follicular lymphoma). As informed by Ipsen, following a review of emerging
data from SYMPHONY-1, the study Independent Data Monitoring Committee advised
that, based on adverse events of secondary hematologic malignancies, the risks
may outweigh potential benefits for patients within this treatment regimen. As
a result of these data, Ipsen is withdrawing TAZVERIK(®) effective
immediately, including both for follicular lymphoma ("FL") and epithelioid
sarcoma (ES).

 

Ipsen has announced that, in addition to withdrawing TAZVERIK(®) from the
market, Ipsen has initiated steps to stop treatment with tazemetostat for all
patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants
will receive standard of care, lenalidomide plus rituximab only. The study
will remain open, with no further enrollment, to continue the long-term safety
follow-up of all participants. Ipsen is also discontinuing all active
tazemetostat clinical trials and expanded access programs. Ipsen is working
with the US Food and Drug Administration ("US FDA") on the next steps to
execute the withdrawal of TAZVERIK(®) and provide all necessary information
to complete this process.

 

The safety and wellbeing of patients is HUTCHMED's top priority. In alignment
with this commitment, HUTCHMED Limited has promptly informed healthcare
professionals, the China National Medical Products Administration ("NMPA"),
the Hong Kong Department of Health and the Macau Health Bureau of this
development. Upon becoming aware of this information, HUTCHMED Limited
immediately placed the product on hold, suspending all sales and shipments,
and notified healthcare institutions to cease prescribing it and pharmacies to
stop dispensing it. HUTCHMED Limited has also immediately notified clinical
trial sites in China to discontinue the use of tazemetostat. Furthermore,
HUTCHMED Limited is also actively cooperating with regulatory authorities to
determine the appropriate next steps for the withdrawal and recall of
TAZVERIK(®) in the Chinese mainland, Hong Kong and Macau.

 

TAZVERIK(®) is a first-in-class methyltransferase inhibitor of EZH2 developed
by Epizyme. TAZVERIK(®) monotherapy was approved by the US FDA in 2020 under
the US FDA accelerated approval program. TAZVERIK(®) received conditional
approval from the NMPA for the treatment of FL as an imported drug. This
approval pathway incorporates the evaluation of overseas trial data,
references overseas regulatory approvals, and bridging study data to adapt
foreign trial results to the Chinese population. Continued registration of
TAZVERIK(®) is subject to continuing obligations, including reporting of
changes in foreign regulatory status, new safety signals and new evidence
affecting the benefit-to-risk profile to patients.

 

The withdrawal is not expected to impact the Company's financial guidance. In
2025, HUTCHMED sales of TAZVERIK(®) were US$2.5 million.

 

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 announcement 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, the further clinical development for
tazemetostat, its expectations as to whether any studies on tazemetostat 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 and the 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
tazemetostat, including as a combination therapy, to meet the primary or
secondary endpoint of a study, to obtain regulatory approval in other
jurisdictions and to gain commercial acceptance after obtaining regulatory
approval; the potential market of tazemetostat for a targeted indication; and
HUTCHMED and/or its partner's ability to fund, implement and complete its
further clinical development and commercialization plans for tazemetostat, and
the timing of these events. In addition, as certain studies rely on the use of
other drug products such as R(2) as combination therapeutics with
tazemetostat, such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval of these
therapeutics. 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 announcement, whether as a result of
new information, future events or circumstances or otherwise.

 

Medical Information

 

This announcement 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 / Tim Stamper                            +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)
 Brunswick - Zhou Yi                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                     (mailto:HUTCHMED@brunswickgroup.com)

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

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

 Deutsche Numis                                      Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith  +44 20 7260 1000

 

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