CStone successfully hosted the first U.S. R&D Day in New York
-- Among CStone's 15 cancer drug candidates, five candidates are in pivotal
late-stage clinical development, with a total of 13 on-going
registrational trials.
-- The Company has implemented its pipeline strategy for early-stage
candidates and combination therapy. With an established clinical
development platform as its growth engine, CStone is at an inflection
point to transition from a R&D focused organization into a
commercial-stage biopharmaceutical company.
-- CStone expects to achieve up to 13 milestones in 2020, including:- An
NDA approval in Taiwan for TIBSOVO® (ivosidenib) for the treatment of
relapsed or refractory acute myeloid leukemia (R/R AML), and become
CStone's first commercialized product in the Greater China region.- A
total of five NDA submissions in Mainland China and Taiwan for CS1001,
an anti-PD-L1 monoclonal antibody; pralsetinib, a RET inhibitor; and
AYVAKIT(TM) (avapritinib), a KIT and PDGFRA inhibitor. CStone plans to
release top-line data from the seven ongoing clinical trials of these
three drug candidates.
-- In the next two to three years, the Company expects to launch four
innovative products, targeting multiple indications. CStone will
leverage its unique and highly efficient R&D platform to bolster its
pipeline and sustain the competitiveness of its portfolio.
SUZHOU, China, Jan. 23, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) announced that it successfully hosted its 2020 U.S. R&D Day in New York on January 21. CStone's management team highlighted major milestones the Company had achieved in research, clinical development, business development and commercialization strategies since its establishment. The management team also provided updates on the progress of the Company's pipeline. Leading academics and key opinion leaders from China and the United States provided insights on the latest trends in the transformation of cancer treatments in China.
Targeting five indications, CStone plans to submit five NDAs in 2020 for CS1001, an anti-PD-L1 monoclonal antibody; pralsetinib, a RET inhibitor; and AYVAKIT(TM) (avapritinib), a KIT and PDGFRA inhibitor, in Mainland China and Taiwan. The Company plans to release the top-line data from seven ongoing clinical trials of these three drug candidates. CStone will focus on developing and commercializing innovative immuno-oncology therapies and precision medicines to address the unmet needs in cancer treatment in China and globally, and drive its Pipeline 2.0 strategy to accelerate its transition toward a commercial-stage biopharmaceutical company with a unique and efficient R&D platform. Moreover, the Company plans to submit NDAs for around 10 indications for four products in the next two to three years.
"China's biopharmaceutical industry is undergoing significant transformation, and CStone is at the forefront of this paradigm shift. With a strategy focused on large cancer indications in China, unmet patient needs, and combination therapies, we are currently conducting over 30 clinical trials, including 13 registrational studies, and 14 combination trials," said Dr. Frank Jiang, Chairman and CEO of CStone. "We are very pleased that Shirley Zhao has joined us as General Manager for Greater China and Head of Commercial Operations, at this inflection point in CStone's transition from clinical-stage to commercial-stage. In the next two to three years, Shirley will lead the establishment of CStone's commercialization capabilities and the launch of multiple innovative products in the Greater China region. Leveraging our unique and highly efficient early-stage clinical development platform, we will continue to strengthen our pipeline and drive biopharmaceutical innovations in China."
Event highlights:
CStone's achievements
-- CStone has established a clinical development-driven business model and
built a world-class clinical team with significant experience in
translational medicine and clinical development. In addition, the
Scientific Advisory Board comprised of four internationally renowned
immuno-oncologists has substantially strengthened the Company's R&D
capabilities in immunotherapies and precision medicines, further
enhancing and optimizing CStone's R&D strategies and product pipeline.
-- CStone has built a risk-balanced and highly competitive
immunotherapy-focused pipeline. Among the Company's 15 cancer drug
candidates, five are in pivotal late-stage clinical development.
AYVAKIT(TM) (avapritinib), developed by Blueprint Medicines, and
TIBSOVO® (ivosidenib), developed by Agios Pharmaceuticals have received
NDA approvals from the U.S. FDA.Among these trials, the clinical studies
of CS1001, an anti-PD-L1 monoclonal antibody, have achieved promising
clinical results with patients treated with CS1001 exceeding one
thousand. In 2019, CStone released encouraging data from the trials of
CS1001 in esophageal carcinoma and a number of other large cancer
indications in China at major medical conferences, including the
American Society of Clinical Oncology (ASCO), the Chinese Society of
Clinical Oncology (CSCO), and the American Society of Hematology (ASH)
annual meetings.The two in-licensed products of CStone's pipeline
candidates that have received NDA approvals from the U.S. FDA are
AYVAKIT(TM) (avapritinib), developed by the partner company, Blueprint
Medicines, and TIBSOVO® (ivosidenib), developed by Agios
Pharmaceuticals. Moreover, Blueprint Medicine has initiated a rolling
NDA submission to the U.S. FDA for pralsetinib. All three candidate
drugs are being investigated in multiple registrational trials in China.
In December, 2019, the global Phase III VOYAGER trial of avapritinib in
third-line gastrointestinal stromal tumors (GIST), and the global Phase
I/II ARROW study of pralsetinib in second- and later-line non-small cell
lung cancer (NSCLC) have both completed their targeted enrollments of
Chinese patients ahead of schedule.
-- CStone developed comprehensive early-stage programs and is scaling up
its combination therapy-focused pipeline. The Company has made
significant progress with two of its backbone immunotherapy assets,
CS1002, an anti-CTLA-4 monoclonal antibody; and CS1003, an anti-PD-1
monoclonal antibody. Both assets generated promising results as
monotherapies in Phase I studies, and CS1003 has already entered a
global Phase III registrational trial. In the development of combination
therapies, CStone recently initiated multiple combination trials and
will continue to advance these combination studies in 2020.
-- Leveraging a unique and highly efficient R&D platform and an innovation
ecosystem, CStone has further strengthened its Pipeline 2.0. The Company
will continue to develop first-in-class and best-in-class drugs and
therapies to maintain its lead in innovations.In 2019, CStone advanced
two drug candidates in its pipeline into clinical development, and
commenced a dozen preclinical research initiatives.
Major milestones expected in 2020 include:
-- One New Drug Application approvalTIBSOVO(®), for the treatment of R/R
AML, is expected to receive an NDA approval in Taiwan and become
CStone's first commercialized product in the Greater China region.
-- 5 NDA submissionsCStone plans to submit five new drug applications in
Mainland China and Taiwan, for CS1001, pralsetinib, and avapritinib.
-- Seven clinical trial data releasesCStone plans to release top-line data
from seven clinical trials of CS1001 (an anti-PD-L1 monoclonal
antibody), pralsetinib, and avapritinib, and six of these trials are
registrational studies.
Development strategies for 2020
-- To consolidate resources to focus on the delivery of the 13 milestones.
-- CStone will build a commercial organization for Greater China equipped
with core commercialization capabilities to enable the Company's
successful transition to the commercial-stage.
-- CStone will continue to seek strategic collaborations with key players,
to drive the future growth of the company.
-- Leveraging its internal R&D, CStone will transition into its Pipeline
2.0 and drive the sustained growth of the Company. In the next three to
five years, CStone will add first-in-class and best-in-class
multi-specific monoclonal antibodies and molecular backbone assets to
its pipeline. The Company plans to further explore tumor
microenvironment modulators, cancer vaccines, new pathway inhibitors,
and innovative combination approaches that could potentially bolster the
effect of anti-PD-(L)1 antibodies.
New product launches
-- In the next two to three years, CStone plans to launch four of its drug
candidates, including avapritinib, pralsetinib, ivosidenib and the
anti-PD-L1 monoclonal antibody CS1001, in the Greater China region,
targeting a total of 10 cancer indications.
Key messages from KOL speakers
-- Dr. Paul Bunn, MD, former President of American Society of Clinical
Oncology (ASCO) and Distinguished Professor at University of Colorado
Cancer Center, commented that latest clinical data of the RET inhibitor
pralsetinib were very encouraging. The trial has already completed the
patient target enrollment, which included naïve patients and patients
who have received platinum-based chemotherapy. He expects this precision
medicine will benefit cancer patients in the future.
-- Dr. Eytan Stein, MD, Professor at the Memorial Sloan Kettering Cancer
Center, commented that compared to current standard chemotherapies,
ivosidenib could bring significant clinical benefits to AML patients and
its high-selectivity could broaden clinical benefits to cancer patients
with an IDH1-mutation.
-- Dr. Yilong Wu, MD, President of the Chinese Thoracic Oncology Group
(C-TONG), past president of Chinese Society of Clinical Oncology (CSCO),
tenured professor of Guangdong Provincial People's Hospital and
Guangdong Lung Cancer Research Institute, emphasized that CStone has
initiated three registrational lung cancer trials and the Company will
play an important role in the lung cancer field in China.- CS1001 is
currently being investigated in the Phase III GEMSTONE-301 study in
patients with locally advanced or unresectable NSCLC, and it could
potentially benefit a wide range of patients. Considering the clinical
practices in China, the trial also included patients who had received
either concomitant or sequential radiochemotherapy. In addition, CS1001
is also being investigated in a Phase III trial in first-line Stage IV
NSCLC.- The study of pralsetinib in RET-fusion NSCLC has demonstrated
promising clinical utility. Due to the persistent high incident rate of
lung cancers and the lack of any effective treatment for RET-mutant
cancers, pralsetinib has the potential of effectively addressing the
current treatment gap in RET-fusion NSCLC in China.
-- Dr. Jian Li, MD, Professor at Beijing Cancer Hospital and Chairman-elect
of the Chinese Society of Clinical Oncology's (CSCO) Committee on GIST,
acknowledged avapritinib's therapeutic promise in the treatment of GIST
in China. Avapritinib is a first-in-class precision medicine approved
by the U.S. FDA for the treatment of GIST, and there is currently no
effective treatment for PDGFRA D842V mutant GIST in China. Available
clinical data of avapritinib in PDGFRA exon 18 mutant GIST (including
PDGFRA D842V mutations) have demonstrated compelling antitumor activity
and a more tolerable safety profile. The drug could significantly
benefit GIST patients who are in need of effective treatment options.
-- Dr. Weiping Zou, MD, PhD, Professor at University of Michigan, Director
of the Center of Excellence for Cancer Immunology and Immunotherapy, and
Chair of the American Association of Cancer Research's (AACR) Cancer
Immunology Working Group (CIMM), commented that CStone has made
significant progress in the past three years, and he will likely to
further collaborate with the Company in selecting Class I drug targets
for future development and he looks forward to facilitating CStone's
transition to Pipeline 2.0.
* * *
About CStone
CStone 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 about CStone Pharmaceuticals, please visit: www.cstonepharma.com
Forward-looking Statement
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.
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