Genetron Holdings Limited (“Genetron Health”, 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,
and its strategic partner CStone Pharmaceuticals (“CStone”, HKEX:
2616) today announced the launch of a multi-center clinical trial
in China for the joint development of a companion diagnostic (CDx)
test for avapritinib. This represents a key milestone in the
companies’ collaboration. Avapritinib is a kinase inhibitor
discovered by CStone’s partner Blueprint Medicines.
Genetron Health and CStone are jointly developing a CDx kit to
detect the D842V mutation in the human platelet-derived growth
factor receptor alpha (PDGFRA) gene using a polymerase chain
reaction (PCR)-based method. The CDx test kit utilizes a real-time
PCR fluorescent probe, combined with specific primers, Taqman
probes, and highly specific Taq enzymes, to detect the mutation
with high specificity and sensitivity in DNA samples. The test has
been validated by the testing center of the National Medical
Products Administration (NMPA) and is now being used in this
multi-center clinical trial in China.
CStone submitted New Drug Applications for avapritinib in PDGFRA
exon 18 mutant gastrointestinal stromal tumors (GIST) to regulatory
agencies in Taiwan and Mainland China in March and April 2020,
respectively. The Chinese regulatory application has been accepted
by the Center for Drug Evaluation (CDE) of NMPA for priority
review. Data from the Phase I/II bridging study of avapritinib
presented at the Chinese Society of Clinical Oncology (CSCO) annual
meeting in 2020 showed that avapritinib was generally well
tolerated in Chinese patients, with a safety profile that is
consistent with previously published results in global studies.
Preliminary results demonstrated the robust clinical activity of
avapritinib in Chinese patients with GIST harboring the PDGFRA
D842V mutation. Among the eight evaluable patients with PDGFRA
D842V mutant GIST who received 300 mg QD doses of avapritinib, all
of the patients had evidence of tumor regression in target lesions,
and five patients achieved a partial response. The overall response
rate (ORR) was 62.5%. The other three patients had stable
disease.
With the rapid development of targeted therapy, immunotherapy,
and other innovative anti-cancer drugs, companion diagnostic tests
have become an integral part of precision therapy in oncology.
Pending avapritinib’s regulatory approval in China, the
collaboration between Genetron Health and CStone is designed to
enhance the commercial potential, maximize benefits to patients,
and promote the development of precision medicine for GIST.
About AvapritinibAvapritinib is a kinase
inhibitor approved by the U.S. Food and Drug Administration (FDA)
under the brand name AYVAKIT™ for the treatment of adults with
unresectable or metastatic GIST harboring a PDGFRA exon 18
mutation, including PDGFRA D842V mutations. Previously, the U.S.
FDA granted Breakthrough Therapy Designation to avapritinib for the
treatment of adult patients with unresectable or metastatic GIST
harboring the PDGFRA D842V mutation.
Avapritinib is not approved for the treatment of any other
indication in the U.S. by the FDA or for any indication in any
other jurisdiction by any other health authority.
Blueprint Medicines is developing avapritinib globally for
patients with advanced and indolent systemic mastocytosis (SM). The
FDA granted breakthrough therapy designation to avapritinib for the
treatment of advanced SM, including the subtypes of aggressive SM,
SM with an associated hematologic neoplasm and mast cell
leukemia.
CStone and Blueprint Medicines have an exclusive collaboration
and license agreement for the development and commercialization of
avapritinib and certain other drug candidates in Mainland China,
Hong Kong, Macau, and Taiwan. Blueprint Medicines retains
development and commercial rights for avapritinib in the rest of
the world.
CStone submitted an NDA for avapritinib to the TFDA and the
China NMPA in March and April 2020, respectively, for the treatment
of adult patients with unresectable or metastatic GIST harboring a
PDGFRA exon 18 mutation. In July 2020, avapritinib received
priority review designation from the China NMPA.
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 CStone PharmaceuticalsCStone
Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused
on developing and commercializing innovative immuno-oncology and
precision medicines to address the unmet medical needs of cancer
patients in China and worldwide. Established in 2015, CStone has
assembled a world-class management team with extensive experience
in innovative drug development, clinical research, and
commercialization. The company has built an oncology-focused
pipeline of 15 drug candidates with a strategic emphasis on
immuno-oncology combination therapies. Currently, 5 late-stage
candidates are at pivotal trials. With an experienced team, a rich
pipeline, a robust clinical development-driven business model and
substantial funding, CStone's vision is to become globally
recognized as a leading Chinese biopharmaceutical company by
bringing innovative oncology therapies to cancer patients
worldwide.
For more information, please visit the www.cstonepharma.com
Safe Harbor Statement This press release
contains forward-looking statements within the meaning of federal
securities laws, including [results of the Phase I/II bridging
study of avapritinib conducted by CStone and] collaboration with
CStone for the joint development of a CDx test for avapritinib,
which involve risks and uncertainties that could cause the actual
results to differ materially from the anticipated results and
expectations expressed in these 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, including statements about the Company’s
beliefs and expectations, 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 Contacts US: Hoki Luk Head
of Investor Relations Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255
Stephanie Carrington Westwicke, an ICR Company
Email: Stephanie.Carrington@westwicke.com Phone: +1 (646)
277-1282
Asia: Bill Zima ICR, Inc. Email: bill.zima@icrinc.com
GenetronIR@icrinc.com
Media Relations Contact Edmond Lococo ICR
Edmond.Lococo@icrinc.com Mobile: +86
138-1079-1408genetron.pr@icrinc.com
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