REG - Hutchmed China Ltd - Inclusion of ORPATHYS in NRDL in China

HUTCHMED (China)Announcement

18/01/2023 14:30

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RNS Number : 1614N  Hutchmed (China) Limited  18 January 2023

 

HUTCHMED Announces Agreement with NHSA for Inclusion of ORPATHYS(®) in the National Reimbursement Drug List in China

 

Hong Kong, Shanghai & Florham Park, NJ -- Wednesday, January 18, 2023:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(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. 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(®). 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
(https://www.hutch-med.com/first-commercial-sale-of-orpathys-milestone-payment/)
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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (https://twitter.com/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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

 

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
(https://aacrjournals.org/cancerres/article/79/13_Supplement/4897/636554/Abstract-4897-Detection-of-MET-mediated-EGFR)
.

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
                                       (mailto: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
                                       (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick             +852 9783 6894 (Mobile) | HUTCHMED@brunswickgroup.com
                                       (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley,     +44 (20) 7886 2500

Panmure Gordon (UK) Limited

 

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