TIDMHCM
RNS Number : 1614N
Hutchmed (China) Limited
18 January 2023
HUTCHMED Announces Agreement with NHSA for Inclusion of
ORPATHYS(R) in the National Reimbursement Drug List in China
Hong Kong, Shanghai & Florham Park, NJ -- Wednesday, J
anuary 18, 2023: HUTCHMED (China) Limited (" HUTCHMED ")
(Nasdaq/AIM: HCM; HKEX:13) today announces, following negotiations
with the China National Healthcare Security Administration
("NHSA"), ORPATHYS(R) (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(R)
, 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(R) , will be
included in this year's NRDL update. As the first and only
selective MET inhibitor in the market, the inclusion of ORPATHYS(R)
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(R) 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(R) 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(R) 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. Reimburse-ment 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(R) . 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(R) 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(R) (osimertinib) and IRESSA(R) (gefitinib); IMFINZI(R)
(durvalumab) and IMJUDO(R) (tremelimumab); ENHERTU(R) (trastuzumab
deruxtecan) and datopotamab deruxtecan in collaboration with
Daiichi Sankyo; ORPATHYS(R) (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
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.
Accessed November 2022.
2. American Cancer Society. What is Lung Cancer? Available at: 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Piotrowska, et al. MET amplification (amp) as a resistance
mechanism to osimertinib. Journal of Clinical Oncology 2017
35:15_suppl, 9020-9020
14. 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.
15. 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
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
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 97 83 6894 (Mobile) | HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
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 or visit 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.
END
MSCBXGDBLUBDGXI
(END) Dow Jones Newswires
January 18, 2023 09:30 ET (14:30 GMT)
HUTCHMED China (AQSE:HCM.GB)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
HUTCHMED China (AQSE:HCM.GB)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024
