Genetron Holdings Limited (“Genetron Health” or the “Company”,
NASDAQ: GTH), a leading precision oncology platform company in
China that specializes in offering molecular profiling tests, early
cancer screening products and companion diagnostics
development, today announced that it has signed a
collaboration agreement with HUTCHMED (China) Limited (“HUTCHMED”)
(Nasdaq/AIM: HCM; HKEX: 13) for the joint development of a
companion diagnostic (CDx) test for ORPATHYS® (savolitinib) in
China.
Under the agreement, the partners plan to
jointly validate and register Genetron Health’s approved NGS-based
8-gene Lung Cancer Assay (Tissue) as CDx for ORPATHYS®. Developed
based on Genetron Health’s proprietary One-step Seq method, the
8-gene Lung Cancer Assay (Tissue) was approved by China’s National
Medical Products Administration (“NMPA”) as an IVD assay in 2020.
This assay is the first approved NGS-based panel for non-small cell
lung cancer (NSCLC) on the market that could detect RNA-based MET
exon 14 skipping alterations for therapy selection and monitoring.
The assay has been commercialized in China for use in hospitals and
has also obtained CE Mark in 2021.
ORPATHYS® is an oral, potent, and highly
selective MET tyrosine kinase inhibitor (“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 gene amplification. Following a priority review,
ORPATHYS® was granted drug registration conditional approval by the
NMPA in China in June 2021.
More than a third of the world’s lung cancer
patients are in China and, among those with NSCLC, approximately
2-3% have tumors with MET exon 14 skipping alterations, a
targetable mutation in the MET gene.1-3 This mutation is more
common (13-22%) among patients with pulmonary sarcomatoid carcinoma
(PSC), a rare and aggressive subtype of NSCLC usually resistant to
chemotherapy.4-5
Dr. Weiguo Su, Executive Director and Chief
Scientific Officer of HUTCHMED, said, “We are delighted to work
with Genetron Health, a leading precision oncology molecular
diagnostic player in China. CDx test is becoming a valuable tool
for the use of ORPATHYS® in the clinical setting for NSCLC patients
harboring MET exon 14 skipping alterations. We look forward to
developing this diagnostic solution with Genetron Health to allow
more patients to benefit from this innovative therapy.”
"ORPATHYS® represents another important
treatment option for NSCLC patients in China, and we are very
excited to partner with HUTCHMED to further develop our Lung 8
assay as their first RNA-based NGS companion diagnostics product
for this novel drug," said Sizhen Wang, co-Founder and CEO of
Genetron Health. “This partnership represents another major CDx
partnership for us and upon approval, we expect this to further
increase Lung 8’s penetration into China’s top hospitals. As
precision medicine and targeted therapeutics continue to gain
traction in China, we continue to expect CDx development to follow
suit. CDx remains a big focus for Genetron, and we are committed to
exploring more ways to develop innovative products to benefit more
patients," Wang said.
Reference:
[1] 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.
[2] World Health Organization. International
Agency for Research on Cancer. Lung Fact Sheet. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed June 2021.
[3] World Health Organization. International
Agency for Research on Cancer. Globocan China Fact Sheet 2020.
Available at
http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed June 2021.
[4] Liu X, et al. Next-generation sequencing of
pulmonary sarcomatoid carcinoma reveals high frequency of
actionable MET gene mutations. J Clin Oncol 2016; 34: 794-802. doi:
10.1200/JCO.2015.62.0674.
[5] Lu S, et al. Once-daily savolitinib in
Chinese patients with pulmonary sarcomatoid carcinomas and other
non-small-cell lung cancers harbouring MET exon 14 skipping
alterations: a multicentre, single-arm, open-label, phase 2 study.
Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi:
10.1016/S2213-2600(21)00084-9.
About
ORPATHYS®(savolitinib)
ORPATHYS® is an oral, potent, and highly
selective MET tyrosine kinase inhibitor (“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) or gene amplification.
ORPATHYS® is marketed in China 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. In 2011, following its discovery and initial
development by HUTCHMED, AstraZeneca and HUTCHMED entered a global
licensing agreement to jointly develop and commercialize
savolitinib. Joint development 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 8-gene Lung Cancer Assay (Tissue)
and One-Step Seq Method
The 8-gene Lung Cancer Assay (Tissue) covers
mutations of EGFR, BRAF, KRAS, HER2 and PIK3CA, translocations of
ALK and ROS1, and MET exon 14 skipping, and 7 of these genes are
recommended biomarkers by the 2018 NCCN guideline for Non-Small
Cell Lung Cancer (NSCLC) patients. This assay has been
approved by the NMPA as an IVD assay to identify EGFR 19 del and
L858R-positive, metastatic NSCLC patients who are candidates for
gefitinib and icotinib tablets, T790M-positive NSCLC patients who
are candidates for osimertinib tablets, and ALK fusion
gene-positive NSCLC patients who are candidates for crizotinib
tablets.
8-gene Lung Cancer Assay (Tissue) was developed
based on the Company’s proprietary One-Step Seq Method, offering
fast and easy-to-use testing procedures, that is suitable for
independent operation within hospitals. With the One-Step Seq
technology, the library construction process is finished in one
step of reaction, minimizing manual operation to one mixture of
reagents with DNA/cDNA. The chance of contamination in the process
is minimal with the “sample in library out” workflow. The assay is
compatible with the Genetron S5 sequencing platform, and together
they offer a two-day turnaround time from sample to report.
About Genetron Holdings
Limited
Genetron Holdings Limited (“Genetron Health” or
the “Company”) (Nasdaq: GTH) is a leading precision oncology
platform company in China that specializes in cancer molecular
profiling and harnesses advanced technologies in molecular biology
and data science to transform cancer treatment. The Company has
developed a comprehensive oncology portfolio that covers the entire
spectrum of cancer management, addressing needs and challenges from
early screening, diagnosis and treatment recommendations, as well
as continuous disease monitoring and care. Genetron Health also
partners with global biopharmaceutical companies and offers
customized services and products. For more information, please
visit ir.genetronhealth.com.
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 more than
4,600 personnel across all its companies, at the center of which is
a team of about 1,500 in oncology/immunology. Since inception it
has advanced 12 cancer drug candidates from in-house discovery into
clinical studies around the world, with its first three oncology
drugs now approved and marketed in China. For more information,
please visit: https://www.hutch-med.com/ or follow the company on
LinkedIn.
Safe Harbor Statement
This press release contains forward-looking
statements. These statements are made under the “safe harbor”
provisions of the U.S. Private Securities Litigation Reform Act of
1995. Statements that are not historical facts, such as our
expectation on further increase of Lung 8’s penetration into
China’s top hospitals, are forward-looking statements.
Forward-looking statements involve inherent risks and
uncertainties, and a number of factors could cause actual results
to differ materially from those contained in any forward-looking
statement. In some cases, forward-looking statements can be
identified by words or phrases such as “may”, “will,” “expect,”
“anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,”
“believe,” “potential,” “continue,” “is/are likely to” or other
similar expressions. Further information regarding these and other
risks, uncertainties or factors is included in the Company’s
filings with the SEC. All information provided in this press
release is as of the date of this press release, and the Company
does not undertake any duty to update such information, except as
required under applicable law.
Investor Relations ContactHoki LukEmail:
hoki.luk@genetronhealth.comPhone: +1 (408) 891-9255
Media Relations ContactYanrong ZhaoGenetron HealthEmail:
yanrong.zhao@genetronhealth.com
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