RCS - Hutchmed China Ltd - NMPA approval for ELUNATE with TYVYT

HUTCHMED (China)Announcement

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RNS Number : 2930F  Hutchmed (China) Limited  21 May 2026

Press Release

 

HUTCHMED and Innovent Jointly Announce NMPA Approval for ELUNATE(®) (Fruquintinib) in Combination with TYVYT(®) (Sintilimab Injection) for the Treatment of Patients with Locally Advanced or Metastatic Renal Cell Carcinoma

 

- Reduced risk of disease progression or death by 63%, with median PFS of
22.2 months in the FRUSICA-2 registration study -

Hong Kong, Shanghai & Florham Park, NJ - Thursday, May 21, 2026: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) and Innovent Biologics, Inc. ("Innovent (https://en.innoventbio.com/)
", HKEX:1801) today jointly announce that the New Drug Application (NDA) for
the combination of ELUNATE(®) (fruquintinib) and TYVYT(®) (sintilimab
injection) has been granted approval by the China National Medical Products
Administration ("NMPA") for the treatment of patients with locally advanced or
metastatic renal cell carcinoma who have failed prior vascular endothelial
growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKI) therapy and have
not received programmed death receptor-1 ("PD-1") or programmed death-ligand 1
("PD-L1") inhibitor therapy in the first-line setting.

 

The approval is supported by data from FRUSICA-2, a randomized, open-label,
active-controlled registration study evaluating the efficacy and safety of
fruquintinib in combination with sintilimab versus axitinib or everolimus
monotherapy for the second-line treatment of patients with locally advanced or
metastatic renal cell carcinoma. The study met its primary endpoint of
progression free survival ("PFS") as assessed by blinded independent central
review ("BICR").

 

"The rapid advancements in targeted therapies, immunotherapies, and their
combination regimens have led to a significant evolution in the treatment
landscape for advanced renal cell carcinoma. Optimizing the selection of
treatment for individual patients is a key focus of clinical interest," said
Professor Dingwei Ye of Fudan University Shanghai Cancer Center and co-lead
Principal Investigator of the FRUSICA-2 study. "The approval of the
fruquintinib and sintilimab combination underscores its potential to address
the pressing medical needs of patients with this challenging disease."

 

"The FRUSICA-2 trial results provided compelling evidence that the
fruquintinib and sintilimab combination could play a meaningful role in
shaping second-line treatment strategies for advanced renal cell carcinoma,"
said Professor Zhisong He of Peking University First Hospital and co-lead
Principal Investigator of the FRUSICA-2 study. "We are optimistic about the
clinical implications of this approval as we strive to provide effective
treatment options for patients."

 

"This approval reaffirms our deep commitment to delivering innovative
therapies to patients facing advanced renal cell carcinoma in China, where
second-line treatment options remain limited," said Mr Johnny Cheng, Acting
Chief Executive Officer and Chief Financial Officer of HUTCHMED. "We are
excited to continue pushing the boundaries of our research - across
monotherapies, combination strategies, and exciting new platforms such as our
ATTC technology - to unlock even greater therapeutic potential across various
tumor types, ultimately providing more impactful and transformative solutions
to patients."

 

Dr Hui Zhou, Chief R&D Officer of Oncology of Innovent, stated: "The
approval is a significant milestone for patients with advanced renal cell
carcinoma in China. It further validates the potential of the sintilimab plus
fruquintinib combination regimen, now approved for two difficult-to-treat
cancers. We are also proud to achieve the 10th approved indication for
sintilimab (TYVYT(®)), and remain committed to advancing clinical value
optimization to benefit an even broader population of cancer patients."

 

About The FRUSICA-2 Trial

Results from the Phase III part of the study were presented at the 2025
European Society for Medical Oncology (ESMO) Congress.
(https://www.hutch-med.com/esmo25-frusica2/) As of the PFS final analysis
cutoff of February 17, 2025, the median follow-up was 16.6 months. The median
PFS as assessed by BICR was 22.2 months with fruquintinib plus sintilimab,
compared to 6.9 months with axitinib/everolimus (stratified hazard ratio  HR 
0.373; stratified log-rank p<0.0001). The objective response rate (ORR)
was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration
of response (DoR) was 23.7 months vs 11.3 months, respectively. Overall
survival data were still evolving at the time of data cutoff with maturity of
approximately 20%. Efficacy benefits were observed in all prognostic risk
groups, as defined by the International mRCC Database Consortium (IMDC)
criteria. The safety profile of the fruquintinib and sintilimab combination
was consistent with the known profiles of each individual treatment.
Additional details may be found at clinicaltrials.gov, using identifier
NCT05522231 (https://clinicaltrials.gov/study/NCT05522231) .

 

About Kidney Cancer and Renal Cell Carcinoma

It is estimated that approximately 435,000 new patients were diagnosed with
kidney cancer worldwide in 2022.(( 1 )) In China, an estimated 74,000 new
patients were diagnosed with kidney cancer in 2022.(( 2 )) Approximately 90%
of kidney tumors are renal cell carcinoma.

 

About Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial
growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a
pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to
have enhanced selectivity that limits off-target kinase activity, allowing for
drug exposure that achieves sustained target inhibition and flexibility for
potential use as part of a combination therapy. 3 

 

About Fruquintinib Approvals

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and
Eli Lilly and Company under the brand name ELUNATE(®). It is approved for the
treatment of patients with metastatic colorectal cancer who have previously
received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and
those who have previously received or are not suitable to receive anti-VEGF
therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS
wild-type) in China. It was included in China's National Reimbursement Drug
List (NRDL) in January 2020.

 

The combination of ELUNATE(®) (fruquintinib) and TYVYT(®) (sintilimab
injection) has conditional approval in China for the treatment of patients
with advanced mismatch repair proficient (pMMR) endometrial cancer who have
failed prior systemic therapy and are not candidates for curative surgery or
radiation.

 

Takeda holds the exclusive worldwide license to further develop,
commercialize, and manufacture fruquintinib outside mainland China, Hong Kong
and Macau, marketing it under the brand name FRUZAQLA(®). Fruquintinib
received approval for the treatment of previously treated metastatic
colorectal cancer in the US, Europe, Japan and many other countries around the
world.

 

About Sintilimab

Sintilimab, marketed as TYVYT(®) (sintilimab injection) in China, is a PD-1
immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly
and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody,
which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/PD-L1
pathway, and reactivates T-cells to kill cancer cells.(( 4  (#_edn4) ))

 

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/) .

 

About Innovent

Innovent is a leading biopharmaceutical company with the mission to empower
patients worldwide with affordable, high-quality biopharmaceuticals. Innovent
discovers, develops, manufactures and commercializes innovative medicines that
target some of the most intractable diseases. Its pioneering therapies treat
cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent
has launched 18 products in the market, 4 assets in Phase III or pivotal
clinical trials and 15 more molecules in early clinical stage. Innovent
partners with over 30 global healthcare companies to improve drug availability
and enhance the quality of patients' lives.

 

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 fruquintinib, the further clinical development for
fruquintinib, its expectations as to whether any studies on fruquintinib 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
fruquintinib, 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 fruquintinib 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 fruquintinib, and
the timing of these events. In addition, as certain studies rely on the use of
other drug products such as sintilimab as combination therapeutics with
fruquintinib, 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 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 / 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
 Duncan Monteith / Ramin Naji                   +44 20 7545 8000

 

 1      The Global Cancer Observatory, kidney cancer fact sheet.
https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf)
. Accessed February 19, 2025.

 2      The Global Cancer Observatory, China fact sheet.
https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf)
. Accessed February 19, 2025.

 3      Sun Q, et al. Discovery of fruquintinib, a potent and highly
selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for
cancer therapy. Cancer Biol Ther. 2014;15(12):1635-45. doi:
10.4161/15384047.2014.964087.

 4      Wang J, et al. Durable blockade of PD-1 signaling links preclinical
efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451.
doi: 10.1080/19420862.2019.1654303.

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