RCS - Hutchmed China Ltd - HUTCHMED and Innovent Announce NDA Acceptance

HUTCHMED (China)Announcement

05/06/2025 07:00

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RNS Number : 4786L  Hutchmed (China) Limited  05 June 2025

Press Release

 

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Renal Cell Carcinoma

 

Hong Kong, Shanghai & Florham Park, NJ - Thursday, June 5, 2025: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) and Innovent Biologics, Inc. ("Innovent") (HKEX: 01801) today jointly
announce that the New Drug Application ("NDA") for the combination of
fruquintinib and sintilimab for the treatment of patients with locally
advanced or metastatic renal cell carcinoma who have failed prior treatment
with one tyrosine kinase inhibitor ("TKI") has been accepted for review by the
China National Medical Products Administration ("NMPA").

 

The NDA 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 advanced renal cell carcinoma.
The study has met its primary endpoint of progression free survival ("PFS"),
as assessed by blinded independent central review (BICR) according to RECIST
1.1 criteria. The combination also demonstrated improvements in secondary
endpoints including objective response rate ("ORR") and duration of response
("DoR"). The safety profile was tolerable and no new safety signals were
observed. Data from FRUSICA-2 will be submitted for presentation at an
upcoming scientific conference. Additional details may be found at
clinicaltrials.gov, using identifier NCT05522231
(https://clinicaltrials.gov/study/NCT05522231) .

 

"Kidney cancer continues to pose significant challenges in China, with limited
treatment options for patients who fail first-line therapies. Submitting this
NDA for the fruquintinib and sintilimab combination for advanced renal cell
carcinoma marks an important step in our efforts to address this unmet need,"
said Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED.
"We are dedicated to making this combination therapy available to patients
with renal cell carcinoma. At the same time, through ongoing research, we
remain focused on exploring the full potential of this combination, as well as
advancing our broader pipeline across multiple cancer types, to provide more
patients with new and effective treatment options."

 

"The NDA acceptance of sintilimab and fruquintinib combination represents a
significant step toward providing a more effective second line treatment
option for patients with advanced renal cell carcinoma in China," said Dr Hui
Zhou, Senior Vice President of Innovent. "Our PD-1 inhibitor, sintilimab
(TYVYT(®)), has solidified its position as a cornerstone of immuno-oncology
(IO) therapy with this NDA as its 10(th) indication, marking a meaningful
milestone in lifecycle management and clinical value optimization."

 

In December 2024, the combination of fruquintinib and sintilimab received
conditional approval from the China NMPA 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, based on data from the FRUSICA-1 study (NCT03903705
(https://www.clinicaltrials.gov/study/NCT03903705) ).

 

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 the China National Reimbursement Drug
List (NRDL) in January 2020. Since its launch in China, over 100,000 patients
with colorectal cancer have been treated with fruquintinib.

 

The combination of ELUNATE(®) (fruquintinib) and TYVYT(®) (sintilimab
injection) has conditional approval in China for the treatment of patients
with advanced 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.

 

The safety and efficacy of fruquintinib for the following investigational uses
have not been established and there is no guarantee that it will receive
health authority approval or become commercially available in any country for
the uses being investigated:

 

About Fruquintinib for Second-line Treatment of Renal Cell Carcinoma

Single-agent targeted therapy continues to be one of the primary choices for
first-line treatment of advanced renal cell carcinoma in China. Notably,
advanced renal cell carcinoma patients who have experienced failure with
single-agent targeted therapy previously still indicate an unmet medical need.

 

Results from a proof-of-concept Phase Ib/II study of fruquintinib plus
sintilimab were published in Targeted Oncology in January 2025. The
combination showed promising efficacy and a tolerable safety profile in this
setting. At the data cutoff of October 9, 2024, all 20 enrolled previously
treated patients were evaluable for efficacy, with a median follow-up duration
of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was
13.9 months and median PFS was 15.9 months. Overall survival ("OS") was not
reached, and the 36-month OS rate was 58.3%. 4 

 

About Sintilimab

Sintilimab, marketed as TYVYT(®) (sintilimab injection) in China, is a PD-1
immunoglobulin G4 monoclonal antibody co-developed and co-commercialized by
Innovent and Eli Lilly and Company, which binds to PD-1 molecules on the
surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and
reactivates T-cells to kill cancer cells.  5 

 

In China, sintilimab has been approved and included in the updated NRDL for
seven indications. The updated NRDL reimbursement scope for TYVYT(®)
(sintilimab injection) includes:

·    For the treatment of relapsed or refractory classic Hodgkin's
lymphoma after two lines or later of systemic chemotherapy;

·    For the first-line treatment of unresectable locally advanced or
metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver
gene mutations;

·    For the treatment of patients with EGFR-mutated locally advanced or
metastatic non-squamous non-small cell lung cancer who progressed after
EGFR-TKI therapy;

·    For the first-line treatment of unresectable locally advanced or
metastatic squamous non-small cell lung cancer;

·    For the first-line treatment of unresectable or metastatic
hepatocellular carcinoma with no prior systematic treatment;

·    For the first-line treatment of unresectable locally advanced,
recurrent or metastatic esophageal squamous cell carcinoma;

·    For the first-line treatment of unresectable locally advanced,
recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

 

Furthermore, sintilimab's eighth indication, in combination with fruquintinib
for the treatment of patients with advanced endometrial cancer with pMMR
tumors that have failed prior systemic therapy and are not candidates for
curative surgery or radiation, was conditional approved by the NMPA in
December 2024.

 

Two NDAs for sintilimab are currently under the NMPA review, including:

·    In combination with ipilimumab as neoadjuvant treatment for
resectable MSI-H/dMMR colon cancer is under the NMPA review and has been
granted Priority Review designation;

·    In combination with fruquintinib for the treatment of patients with
locally advanced or metastatic renal cell carcinoma who failed prior treatment
with a TKI.

 

In addition, two clinical studies of sintilimab have met their primary
endpoints:

·    Phase 2 study of sintilimab monotherapy as second-line treatment of
esophageal squamous cell carcinoma;

·    Phase 3 study of sintilimab monotherapy as second-line treatment for
squamous non-small cell lung cancer with disease progression following
platinum-based chemotherapy;

 

Statement: Innovent does not recommend the use of any unapproved
drug(s)/indication(s).

 

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. Since inception,
HUTCHMED 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 founded in 2011 with the
mission to empower patients worldwide with affordable, high-quality
biopharmaceuticals. The company 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 15 products in the market.
It has 3 new drug applications under regulatory review, 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, including Lilly,
Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

 

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent
maintains the highest standard of industry practices and works collaboratively
to advance the biopharmaceutical industry so that first-rate pharmaceutical
drugs can become widely accessible. For more information, visit
www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

 

Statement:

(1) Innovent does not recommend the use of any unapproved drug
(s)/indication(s).

(2) Ramucirumab (Cyramza(®)) and Selpercatinib (Retsevmo(®)) and
Pirtobrutinib (Jaypirca(®)) were developed by Eli Lilly and Company.

 

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 the fruquintinib and sintilimab combination for the
treatment of patients with advanced renal cell carcinoma and the further
clinical development of the fruquintinib and sintilimab combination 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 the fruquintinib and sintilimab combination for the treatment of patients
with advanced renal cell carcinoma in China, or other jurisdictions, its
potential to gain expeditious approvals from regulatory authorities, the
safety profile of fruquintinib, HUTCHMED's ability to fund, implement and
complete its further clinical development and commercialization plans for the
fruquintinib and sintilimab combination, 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 U.S. Securities and
Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited.
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    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    Xu H, et al. Fruquintinib Plus Sintilimab in Patients with
Treatment‑Naïve and Previously Treated Advanced Renal Cell Carcinoma:
Results from a Phase Ib/II Clinical Trial. Targeted Oncology. 2025;
20:113-125. doi.org/10.1007/s11523-024-01120-6.

 5    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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