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AYVAKIT® (avapritinib) Companion Diagnostic Test Enters Priority Review and Approval Process in China

Mon 26th July, 2021 11:00am
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BEIJING, July 26, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited
(“Genetron Health” or the “Company”, NASDAQ: GTH), today announced
that its AYVAKIT(®) (avapritinib) companion diagnostic (CDx) kit, developed
in partnership with CStone Pharmaceuticals (“CStone”, HKEX: 2616) has
entered the priority review and approval process under the National Medical
Products Administration (NMPA) in China.

The test kit is the first companion diagnostic product developed in China to
go through the NMPA’s accelerated review channel. This channel expedites the
review of qualified medical devices that are deemed urgent and necessary, so
that they can be applied sooner in clinical settings.

During the process, the Center for Medical Device Evaluation (CMDE) under the
NMPA carries out a priority technical review, working closely with the company
to expedite the process. Provincial food and drug authorities also make the
review of the product a priority throughout their registered quality
management systems. The product then goes through a priority administrative
process under the NMPA, which approves the product at the end.

Gastrointestinal stromal tumor (GIST) patients with human platelet-derived
growth factor receptor alpha (PDGFRA) gene mutations lack effective treatment
drugs. AYVAKIT(®) has demonstrated remarkable efficacy and acceptable safety
in Chinese patients with unresectable or metastatic GIST harboring PDGFRA exon
18 mutations, including D842V.

As a proprietary companion diagnostic for AYVAKIT(®), the CDx kit can be used
to effectively detect PDGFRA D842V gene mutation in GIST patients, providing
accurate molecular diagnosis for targeted drug application which may translate
into durable clinical benefits for these patients.

The AYVAKIT(®) CDx test kit is based on a real-time PCR fluorescent probe,
specific primers, Taqman probes, and highly specific Taq enzymes to detect
gene mutations. This enables the test kit to detect mutations with higher
specificity and sensitivity in DNA samples. A clinical study utilizing the
test kit was carried out at the Beijing Cancer Hospital, Harbin Medical
University Cancer Hospital and Shanghai Tenth People's Hospital, demonstrating
data on par with that of the Sanger sequencing method and exhibiting total
coincidence rates of over 99%.

"I am very pleased that the AYVAKIT(®) companion diagnostics test kit has
entered the NMPA priority review and approval process, distinguishing itself
through innovative, original technology and strong performance data. The
development of such companion diagnostics products can enable doctors to
choose more suitable, targeted drugs for patients, while lowering the costs of
drug development, accelerating the development process, and improving drug
safety and effectiveness. Genetron Health is committed to exploring more
innovative pathways for the development of new drugs and companion
diagnostics, providing more choices for patient care," said Sizhen Wang,
Co-Founder and CEO of Genetron Health.

“Precision medicine is one of CStone's core strategies. As the world's first
therapeutic approved for GIST based on driver mutations, AYVAKIT(®) was
approved by the NMPA in March 2021 after passing the NMPA’s priority review
process. Molecular diagnosis has become imperative for GIST patients. I am
very pleased that the AYVAKIT(®) companion diagnostic kit has also entered
the priority review process. I look forward to the early approval of this
diagnostic kit, so that more GIST patients in China can benefit from precision
treatment,” said Dr. Archie Tse, Chief Scientific Officer of CStone.

About AYVAKIT(®) (avapritinib)
AYVAKIT(®) (avapritinib) is a kinase inhibitor approved by the China National
Medical Products Administration (NMPA) for the treatment of adults with
unresectable or metastatic GIST harboring the PDGFRA exon 18 mutation,
including PDGFRA D842V mutations.

The U.S. Food and Drug Administration (FDA) has approved AYVAKITTM for the
treatment of two indications: adults with advanced systemic mastocytosis (SM),
including aggressive SM (ASM), SM with an associated hematological neoplasm
(SM-AHN) and mast cell leukemia (MCL), and adults with unresectable or
metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V

This medicine is approved by the European Commission under the brand name
AYVAKYT(®) for the treatment of adults with unresectable or metastatic GIST
harboring the PDGFRA D842V mutation.

AYVAKIT(®)/AYVAKYT(®) is not approved for the treatment of any other
indication in the U.S., Europe or Greater China, or for any indication in any
other jurisdiction by any other health authority.

Blueprint Medicines is developing AYVAKIT(®) globally for the treatment of
advanced and non-advanced SM. The FDA granted breakthrough therapy designation
to AYVAKIT(®) for the treatment of advanced SM, including the subtypes of
ASM, SM-AHN, and MCL, and for the treatment of moderate to severe indolent SM.

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
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on
researching, 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, CStone has received three
drug approvals in Greater China, including two in Mainland China and one in
Taiwan. CStone's vision is to become globally recognized as a world-renowned
biopharmaceutical company by bringing innovative oncology therapies to cancer
patients worldwide.

For more information about CStone, please visit: www.cstonepharma.com

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,
including statements about the priority review and approval process in China,
the collaboration with CStone for the joint development of a CDx test for
avapritinib 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 Contact
Hoki Luk
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255

Media Relations Contact
Yanrong Zhao
Genetron Health


GlobeNewswire, Inc. 2021
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