HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13)
today announces, following negotiations with the China National
Healthcare Security Administration (“NHSA”), ORPATHYS®
(savolitinib) has been included in the updated National
Reimbursement Drug List (“NRDL”) for the treatment of locally
advanced or metastatic non-small cell lung cancer (“NSCLC”) adult
patients with MET exon 14-skipping alterations who have progressed
after or unable to tolerate platinum-based chemotherapy. The
updated NRDL will take effect from March 1, 2023.
Savolitinib, marketed in China under the brand
name ORPATHYS®, is an oral, potent and highly selective MET
tyrosine kinase inhibitor (“TKI”) jointly developed by AstraZeneca
and HUTCHMED with HUTCHMED taking the lead in China, and
commercialized by AstraZeneca worldwide.
Dr Weiguo Su, Chief Executive Officer and Chief
Scientific Officer of HUTCHMED, said: “The NRDL has significantly
broadened access to novel medicines for Chinese patients. We are
gratified to see that our third novel oncology medicine, ORPATHYS®,
will be included in this year’s NRDL update. As the first and only
selective MET inhibitor in the market, the inclusion of ORPATHYS®
will increase the affordability and access to this novel
treatment.”
Leon Wang, Executive Vice President,
International and China President of AstraZeneca, said: “The
inclusion of ORPATHYS® on the NRDL is exciting news for NSCLC
patients in China with MET exon 14 skipping alterations who will
now have improved access to the only targeted medicine approved in
this setting and who often do not respond well to chemotherapy.
Since its launch in mid-2021, ORPATHYS® has helped patients
in need achieve better outcomes, and we are excited about the
potential to reach even more patients in China with this
transformational medicine.”
ORPATHYS® received conditional approval in China
in June 2021 for the treatment of certain patients with NSCLC with
MET exon 14 skipping alterations.
About the NRDL
In recent years, the government in China has
placed great importance on improving the affordability of drug
treatments for the public. The NHSA regularly convenes a broad
network of experts in medicine, pharmacology and pharmacoeconomics
to identify innovative drugs to be considered for inclusion in the
NRDL. This has led to an expansion of the reimbursement of Category
B drugs, which increasingly include novel oncology drugs.
Reimbursement of Category B drugs requires varying degrees of
copayment from patients, depending on their province of residence
or type of NHSA insurance scheme enrollment. Inclusion on the NRDL
for all listed drugs is subject to renewal every two years.
In this update round, the NHSA has added 23
oncology drugs to the NRDL, including ORPATHYS®. Effective March 1,
2023, medicines included on the NRDL are expected to be made
available in pharmacies of major hospitals in China at the
negotiated price in accordance with NRDL payment standards, and
reimbursement will commence for participants in the NHSA insurance
schemes, subject to applicable co-payments by participants.
About Savolitinib
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.
Savolitinib is marketed in China under the brand
name ORPATHYS® for the treatment of patients with NSCLC with MET
exon 14 skipping alterations who have progressed following prior
systemic therapy or are unable to receive chemotherapy. 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 NSCLC and MET
aberrations
Lung cancer is the leading cause of cancer death
among men and women, 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 U.S. and
Europe and 30-40% of patients in Asia have EGFRm NSCLC. 3,4,5,6
MET is a tyrosine kinase receptor that has an
essential role in normal cell development.7 MET overexpression
and/or amplification can lead to tumor growth and the metastatic
progression of cancer cells, and is the primary mechanism of
acquired resistance to EGFR TKIs for metastatic EGFR-mutated
NSCLC.7,8 Approximately 2-3% of NSCLC patients have tumors with MET
exon 14 skipping alterations, a targetable mutation in the MET
gene.9 Among patients who experience disease progression
post-osimertinib treatment, approximately 15-50% present with MET
aberration. 10,11,12,13,14 The prevalence of MET
depends on the sample type, detection method and assay cut-off
used.15
About AstraZeneca and HUTCHMED
collaboration
In 2011, AstraZeneca and HUTCHMED entered into a
global licensing and collaboration agreement to jointly develop and
commercialize savolitinib. Joint development of savolitinib in
China is led by HUTCHMED, while AstraZeneca leads development
outside of China. HUTCHMED is responsible for the marketing
authorization, manufacturing and supply of savolitinib in China.
AstraZeneca is responsible for the commercialization of savolitinib
in China and worldwide. Sales of savolitinib are recognized by
AstraZeneca.
About AstraZeneca in lung
cancer
AstraZeneca is working to bring patients with
lung cancer closer to cure through the detection and treatment of
early-stage disease, while also pushing the boundaries of science
to improve outcomes in the resistant and advanced settings. By
defining new therapeutic targets and investigating innovative
approaches, the Company aims to match medicines to the patients who
can benefit most.
The Company’s comprehensive portfolio includes
leading lung cancer medicines and the next wave of innovations
including TAGRISSO® (osimertinib) and IRESSA® (gefitinib); IMFINZI®
(durvalumab) and IMJUDO® (tremelimumab); ENHERTU® (trastuzumab
deruxtecan) and datopotamab deruxtecan in collaboration with
Daiichi Sankyo; ORPATHYS® (savolitinib) in collaboration with
HUTCHMED; as well as a pipeline of potential new medicines and
combinations across diverse mechanisms of action.
AstraZeneca is a founding member of the Lung
Ambition Alliance, a global coalition working to accelerate
innovation and deliver meaningful improvements for people with lung
cancer, including and beyond treatment.
About AstraZeneca in
oncology
AstraZeneca is leading a revolution in oncology
with the ambition to provide cures for cancer in every form,
following the science to understand cancer and all its complexities
to discover, develop and deliver life-changing medicines to
patients.
The Company's focus is on some of the most
challenging cancers. It is through persistent innovation that
AstraZeneca has built one of the most diverse portfolios and
pipelines in the industry, with the potential to catalyze changes
in the practice of medicine and transform the patient
experience.
AstraZeneca has the vision to redefine cancer
care and, one day, eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global,
science-led biopharmaceutical company that focuses on the
discovery, development, and commercialization of prescription
medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
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. It has about 5,000
personnel across all its companies, at the center of which is a
team of about 1,800 in oncology/immunology. Since inception
HUTCHMED has been focused on bringing cancer drug candidates from
in-house discovery to patients around the world, with its first
three oncology drugs now approved and marketed in China. For more
information, please visit: www.hutch-med.com or follow us on
LinkedIn.
References
- 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.
Accessed November 2022.
- American Cancer Society. What is
Lung Cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Accessed November 2022.
- Knight SB, et al. Progress and
prospects of early detection in lung cancer. Open Biol. 2017;7(9):
170070.
- 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.
- 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).
- 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.
- Uchikawa E, et al. Structural basis
of the activation of c-MET receptor. Nat Commun.
2021;12(4074).
- Wang Q, et al. MET inhibitors for
targeted therapy of EGFR TKI-resistant lung cancer. Journal of
Hematology & Oncology. 2019;63.
- Vuong HG, et al.
Clinicopathological implications of MET exon 14 mutations in
non-small cell lung cancer – A systematic review and meta-analysis.
Lung Cancer 2018; 123: 76-82. doi:
10.1016/j.lungcan.2018.07.006.
- Soria JC, et al. Osimertinib in
Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl
J Med. 2018;378(2):113-125. doi:10.1056/NEJMoa1713137.
- Mok TS, et al. Osimertinib or
Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J
Med. 2017;376(7):629-640. doi:10.1056/NEJMoa1612674.
- Hartmaier R, et al. Tumor genomics
in patients (pts) with advanced epidermal growth factor receptor
mutant (EGFRm) non-small cell lung cancer (NSCLC) whose disease has
progressed on first-line (1L) osimertinib therapy in the Phase II
ORCHARD study [abstract]. In: Proceedings of the American
Association for Cancer Research Annual Meeting 2022; Abstract nr
LB078 / 3.
- Piotrowska, et al. MET
amplification (amp) as a resistance mechanism to osimertinib.
Journal of Clinical Oncology 2017 35:15_suppl, 9020-9020
- Hartmaier, et al. Detection of
MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in
advanced non-small cell lung cancer (NSCLC): biomarker analysis of
the TATTON study. Cancer Res (2019) 79 (13_Supplement): 4897.doi:
10.1158/1538-7445.AM2019-4897.
- Coleman N, et al. Beyond epidermal
growth factor receptor: MET amplification as a general resistance
driver to targeted therapy in oncogene-driven non-small-cell lung
cancer. ESMO Open. 2019;6(6).
Forward-Looking Statements
This announcement 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 for the
commercialization of savolitinib in China, the potential benefits
and further clinical development of savolitinib, its expectations
as to whether further studies 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
the commercial acceptance of savolitinib, the impact of the
inclusion of savolitinib on the NRDL on sales of the drug and its
pricing, clinical trial enrollment rates, 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
savolitinib to obtain regulatory approval for a targeted indication
in different jurisdictions and the sufficiency of funding. In
addition, as certain studies rely on the use of osimertinib or
durvalumab as combination therapeutics, such risks and
uncertainties include assumptions regarding their safety, efficacy,
supply and continued regulatory approval and the impact of the
COVID-19 pandemic on general economic, regulatory and political
conditions. 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 with The Stock Exchange of Hong
Kong Limited. 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.
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).
HUTCHMED Contacts
|
Investor Enquiries |
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Mark Lee, Senior Vice President |
+852 2121 8200 |
|
Annie Cheng, Vice President |
+1 (973) 567 3786 |
|
|
|
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Media Enquiries |
|
|
Americas – Brad Miles, Solebury |
+1 (917) 570 7340 (Mobile) |
bmiles@soleburystrat.com |
|
Europe – Ben Atwell / Alex Shaw, FTI |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) |
HUTCHMED@fticonsulting.com |
|
Asia – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) |
HUTCHMED@brunswickgroup.com |
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Nominated Advisor |
|
|
Atholl Tweedie / Freddy Crossley, Panmure Gordon
(UK) Limited |
+44 (20) 7886 2500 |
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