REG - Hutchmed China Ltd - China Approval based on Phase III SACHI Trial

HUTCHMED (China)Announcement

Yesterday 09:30

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250630:nRSd9499Oa&default-theme=true

RNS Number : 9499O  Hutchmed (China) Limited  30 June 2025

 

HUTCHMED Announces China Approval for ORPATHYS(®) in Combination with
TAGRISSO(®) for the Treatment of Lung Cancer Patients with MET Amplification
After Progression on First-Line EGFR Inhibitor Therapy

- Approval based on Phase III SACHI Trial results which showed a 66% reduced
risk of progression or death as compared to platinum-based chemotherapy -

- The only all-oral combination treatment option for these patients -

- Consistent benefit regardless of first-line EGFR inhibitor therapy -

 

Hong Kong, Shanghai & Florham Park, NJ -  Monday, June 30, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application
("NDA") for the combination of ORPATHYS(®) (savolitinib) and TAGRISSO(®)
(osimertinib) has been granted approval by the China National Medical Products
Administration ("NMPA") for the treatment of patients with locally advanced or
metastatic epidermal growth factor receptor ("EGFR") mutation-positive
non-squamous non-small cell lung cancer ("NSCLC") with MET amplification after
disease progression on EGFR tyrosine kinase inhibitor ("TKI") therapy.
ORPATHYS(®) is an oral, potent and highly selective MET TKI. TAGRISSO(®) is
a third-generation, irreversible EGFR TKI. This approval also triggers a US$11
million milestone payment from AstraZeneca, which markets both ORPATHYS(®)
and TAGRISSO(®) in China.

 

ORPATHYS(®) was the first selective MET inhibitor approved in China,
indicated for adult patients with locally advanced or metastatic NSCLC with
MET exon 14 skipping alteration. This new approval by the NMPA was based on
data from the SACHI Phase III trial of the ORPATHYS(®) and TAGRISSO(®)
combination (NCT05015608 (https://clinicaltrials.gov/ct2/show/NCT05015608) ),
having met the pre-defined primary endpoint of progression-free survival
("PFS") in a pre-planned interim analysis. Primary results were presented at
the American Society of Clinical Oncology ("ASCO") Annual Meeting in June
2025. In 2024 the NMPA designated the combination as a Breakthrough Therapy
(https://www.hutch-med.com/orpathys-tagrisso-china-breakthrough/) , and in
2025 it granted the NDA Priority Review
(https://www.hutch-med.com/orpathys-tagrisso-nda-acceptance-in-china-with-priority-review-status-for-lung-cancer-after-egfri/)
.

 

Professor Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest
Hospital, School of Medicine, Shanghai Jiaotong University, and Principal
Investigator of the SACHI trial, said, "The approval of the ORPATHYS(®) and
TAGRISSO(®) combination is a significant milestone in addressing the complex
challenges of lung cancer treatment in China, where the EGFR mutation is
common amongst NSCLC patients. For patients who develop MET amplification
after progressing on EGFR inhibitors, the combination offers a continued
all-oral, chemotherapy-free approach to tackle a critical resistance
mechanism. As a researcher and clinician, I am excited about the opportunity
to offer this targeted therapy to patients, improving their treatment outcomes
and quality of life through innovative research."

 

"The NMPA approval marks an important step forward in our mission to address
MET-driven progression following first-line EGFR-inhibitor therapy in NSCLC
patients." said Dr Weiguo Su, Chief Executive Officer and Chief Scientific
Officer of HUTCHMED. "Our collaboration with AstraZeneca, built on a shared
vision to transform oncology care, has been crucial in reaching this
achievement. We are committed to advancing this partnership, continuing our
research into further treatment settings, and bringing this innovative
combination to patients in China and beyond."

 

Ms Mary Guan, General Manager of AstraZeneca China Oncology Business, said:
"This milestone marks the third indication of ORPATHYS(®) approved in China,
bringing a new treatment option to lung cancer patients who develop MET
amplification after progressing on EGFR inhibitor therapy. Through our
partnership with HUTCHMED, we are committed to expanding the reach of the
ORPATHYS(®) and TAGRISSO(®) combination to address progression on first-line
therapy and help even more patients with this form of lung cancer."

 

In the intention to treat (ITT) population of the SACHI trial, the
ORPATHYS(®) and TAGRISSO(®) combination reduced the risk of disease
progression by 66% with a median PFS of 8.2 months, compared to 4.5 months for
chemotherapy, as assessed by investigators. The independent review committee
(IRC) also reported a 60% risk reduction in disease progression, with a median
PFS of 7.2 months versus 4.2 months, respectively. The safety profile of the
ORPATHYS(®) and TAGRISSO(®) combination was tolerable and no new safety
signals were observed. Treatment-emergent adverse events of Grade 3 or above
occurred in 57% of patients in both the ORPATHYS(®) plus TAGRISSO(®) group
and the chemotherapy group, suggesting a favorable safety profile.

 

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death, accounting for about
one-fifth of all cancer deaths. 1  Lung cancer is broadly split into NSCLC and
small cell lung cancer, with 80-85% classified as NSCLC. 2  The majority of
NSCLC patients (approximately 75%) are diagnosed with advanced disease, and
approximately 10-15% of NSCLC patients in the US and Europe and 30-40% of
patients in Asia have EGFR-mutated ("EGFRm") NSCLC. 3 (, 4 , 5 , 6 )

 

MET is a tyrosine kinase receptor that has an essential role in normal cell
development. MET overexpression and/or amplification can lead to tumor growth
and the metastatic progression of cancer cells, and is one of the mechanisms
of acquired resistance to EGFR TKI for metastatic EGFRm NSCLC. 7 (, 8 )

 

About ORPATHYS(®)

ORPATHYS(®) (savolitinib) is an oral, potent and highly selective MET TKI
that has demonstrated clinical activity in advanced solid tumors. It blocks
atypical activation of the MET receptor tyrosine kinase pathway that occurs
because of mutations (such as exon 14 skipping alterations or other point
mutations), gene amplification or protein overexpression.

 

ORPATHYS(®) is approved in China and is marketed by AstraZeneca for the
treatment of adult patients with locally advanced or metastatic NSCLC with MET
exon 14 skipping alteration, representing the first selective MET inhibitor
approved in China. It is currently under clinical development for multiple
tumor types, including lung, kidney, and gastric cancers as a single treatment
and in combination with other medicines.

 

About TAGRISSO(®)

TAGRISSO(®) (osimertinib) is a third-generation, irreversible EGFR-TKI with
proven clinical activity in NSCLC, including against central nervous system
(CNS) metastases. TAGRISSO(®) (40mg and 80mg once-daily oral tablets) has
been used to treat nearly 800,000 patients across its indications worldwide
and AstraZeneca continues to explore TAGRISSO(®) as a treatment for patients
across multiple stages of EGFRm NSCLC.

 

There is an extensive body of evidence supporting the use of TAGRISSO(®) as
standard of care in EGFRm NSCLC. TAGRISSO(®) improved patient outcomes in
early-stage disease in the ADAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-demonstrated-strong-overall-survival-benefit-in-the-adaura-phase-iii-trial.html)
, locally advanced disease in the LAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-improved-pfs-in-stage-iii-lung-cancer.html)
, late-stage disease in the FLAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2019/tagrisso-significantly-improves-overall-survival-in-the-phase-iii-flaura-trial-for-1st-line-egfr-mutated-non-small-cell-lung-cancer-09082019.html)
, and with chemotherapy in the FLAURA2 Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemotherapy-extended-median-progression-free-survival-by-nearly-9-months-in-egfr-mutated-advanced-lung-cancer-in-flaura2-phase-iii-trial.html)
.

 

About ORPATHYS(®) and TAGRISSO(®) Combination Development in EGFR-mutated NSCLC

Among patients who experience disease progression following treatment with a
third-generation EGFR TKI, approximately 15-50% present with MET aberration,
depending on the sample type, detection method and assay cut-off used.
TAGRISSO(®) is a third-generation, irreversible EGFR-TKI with proven clinical
activity in NSCLC, including against central nervous system metastases.
Treatment with ORPATHYS(®) in combination with TAGRISSO(®) has been studied
extensively in these patients in the TATTON (NCT02143466
(https://clinicaltrials.gov/study/NCT02143466) ) and SAVANNAH (NCT03778229
(https://clinicaltrials.gov/study/NCT03778229#participation-criteria) )
studies. The encouraging results led to the initiation of several Phase III
trials in this setting including the SACHI trial in China (NCT05015608
(https://clinicaltrials.gov/study/NCT05015608) ) and the global SAFFRON trial
(NCT05261399 (https://www.clinicaltrials.gov/study/NCT05261399) ), as well as
the SANOVO trial in China (NCT05009836
(https://clinicaltrials.gov/study/NCT05009836) ).

 

This combination represents a promising chemotherapy-free oral treatment
strategy to address mechanisms of resistance in this advanced setting.
Positive data from the SACHI randomized Phase III trial led to the filing of a
second NDA in China
(https://www.hutch-med.com/orpathys-tagrisso-nda-acceptance-in-china-with-priority-review-status-for-lung-cancer-after-egfri/)
. Strong data from the SAVANNAH single-arm Phase II study was recently
presented at the European Lung Cancer Congress
(https://www.hutch-med.com/elcc25/) (ELCC) in March 2025 demonstrated high,
clinically meaningful and durable objective response rate (ORR), with
consistent safety results. The SAFFRON randomized Phase III trial is
progressing. Following AstraZeneca's consultation with the US Food and Drug
Administration ("FDA"), we look forward to completing the SAFFRON trial as
soon as possible to support potential US and other global registration
filings.

 

SACHI: The SACHI China Phase III trial met the primary endpoint of PFS during
its interim analysis towards the end of 2024 and a NDA was accepted and
granted Breakthrough Therapy Designation and Priority Review status in China
in December 2024. SACHI evaluated the combination of ORPATHYS(®) and
TAGRISSO(®) for the treatment of patients with EGFRm, MET-amplified locally
advanced or metastatic NSCLC after progression on EGFR TKI compared to
platinum-based doublet chemotherapy. Results were presented at the ASCO Annual
Meeting in June 2025.

 

SAFFRON: In 2023, ORPATHYS(®) and TAGRISSO(®) received Fast Track
Designation from the US FDA in this setting. The global SAFFRON Phase III
trial is currently ongoing to assess the ORPATHYS(®) plus TAGRISSO(®)
combination versus platinum-based doublet chemotherapy in patients with EGFRm,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC
following progression on treatment with TAGRISSO(®). Patients are being
prospectively selected using the high MET level cut-off identified in
SAVANNAH.

 

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 ORPATHYS(®), the further clinical development for
ORPATHYS(®), its expectations as to whether any studies on ORPATHYS(®) 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
ORPATHYS(®), 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 ORPATHYS(®) 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 ORPATHYS(®), and
the timing of these events. In addition, as certain studies rely on the use of
other drug products such as TAGRISSO(®) as combination therapeutics with
ORPATHYS(®), 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.

Inside Information

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in
the European Union (Withdrawal) Act 2018).

 

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 / Emma Earl / Rupert Dearden    +44 20 7886 2500

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

 

 1   World Health Organization. International Agency for Research on Cancer.
All cancers fact sheet. Available at:
https://gco.iarc.fr/today/-data/factsheets/cancers/39-All-cancers-fact-sheet.pdf
(https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf)
. Accessed November 2022.

 2   American Cancer Society. What is Lung Cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html
(https://www.cancer.org/cancer/lung-cancer/about/what-is.html) . Accessed
November 2022.

 3  Knight SB, et al. Progress and prospects of early detection in lung
cancer. Open Biol. 2017;7(9): 170070.

 4  Keedy VL, et al. American Society of Clinical Oncology Provisional
Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for
Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR
Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

 5  Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small
cell lung cancer: a systematic review and meta-analysis. Oncotarget.
2016;7(48).

 6  Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single
Institution Study and Systematic Review of European Incidence. Int J Clin
Exp Pathol. 2013:6;2800-12.

 7  Uchikawa E, et al. Structural basis of the activation of c-MET receptor.
Nat Commun. 2021;12(4074).

 8  Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant
lung cancer. Journal of Hematology & Oncology. 2019;63.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCFIFITRFIIVIE