SHANGHAI, July 17, 2017 /PRNewswire/ -- CStone
Pharmaceuticals today announced that it has received Clinical Trial
Application (CTA) approval from the China Food and Drug
Administration (CFDA) to conduct clinical trials in China with the investigational agent CS1001,
which is China's first fully
human, full-length anti-PD-L1 monoclonal antibody to successfully
enter the clinical development stage.
After eight months of review,
the CFDA granted CTA approval to CS1001, the first fully human
anti-PD-L1 monoclonal antibody generated by the world leading OMT
transgenic animal platform. CS1001 is independently developed and
wholly owned by CStone Pharmaceuticals. As a fully human,
full-length antibody that mirrors natural human IgG, CS1001 reduces
the risk of immunogenicity and potential toxicities in patients.
CStone Pharmaceuticals is initiating Phase 1 clinical trials in
patients with advanced cancer. Planned indications include those
tumor types with high incidence and prevalence rates in
China.
"I am very pleased that CStone's first IND application is
approved by the CFDA, allowing us to initiate clinical trials in
China. This event is a significant
milestone for the company," said
Dr. Frank Jiang, CEO of CStone
Pharmaceuticals. Dr. Jiang further explains that this approval lays
a solid foundation for subsequent development of multiple
combination therapies using anti-PD-L1 as the backbone treatment.
CStone will leverage its unique advantages in clinical development
and rich oncology pipeline to bring significant clinical benefit to
cancer patients in China and
beyond.
Immuno-oncology, led by PD-1 / PD-L1 checkpoint inhibitors and
with its proven breakthrough therapeutic effects in a wide range of
tumors, signifies a new era for cancer therapies worldwide.
Currently, five anti-PD-1 / PD-L1 drugs are approved by the U.S.
FDA in more than 10 indications, but none has been approved in
China. As such, CStone's CS1001
has the potential to address the urgent needs of Chinese patients
for this class of drugs.
About CStone pharmaceuticals
CStone Pharmaceuticals is a biopharmaceutical company devoted to
the development of a new generation of innovative drugs. With its
broad immuno-oncology pipeline, CStone is pursuing a development
strategy focusing on combination therapy. In July of 2016, CStone
Pharmaceuticals announced the completion of its $150 million Series A financing, led by three
prestigious VC/PE funds: Oriza Seed Venture Capital, Boyu Capital
and WuXi Healthcare Ventures. All members of the management team
are seasoned executives from top multinational pharmaceutical
companies. CStone has successfully built up an industry leading
team with clinical development and translational medicine as its
core competence. This enables CStone to accelerate drug approval
timeline, while at the same time, apply global standard practices
to ensure clinical trial quality. The unique advantages in clinical
development, funding and pipeline also positions CStone as the
partner of choice for multinational pharmaceutical / biotech
companies to develop drugs in China and the Asia
Pacific region.
About CS1001
CS1001 (formerly codenamed WBP3155), independently developed and
wholly owned by CStone Pharmaceuticals, is the first fully human,
full-length innovative anti-PD-L1 drug candidate in China. Authorized by the U.S. based Ligand
Corporation, CS1001 is also the first monoclonal antibody developed
by the world leading OMT transgenic animal platform, which can
generate fully human antibodies in one step.
About PD-L1
Programmed cell death ligand-1 (PD-L1) is a 40kDa type I
transmembrane protein. Under normal physiological conditions, the
immune system responds to antigens in the lymph nodes or spleen by
promoting the proliferation of antigen specific T cells. The
interaction of programmed cell death protein-1 (PD-1) and PD-L1 can
transduce inhibitory signals to reduce the proliferation of T cells
and control an overreaction by the immune system, enabling the body
to resume its natural immune balance. However, within the tumor
microenvironment, cancer cells can up-regulate PD-L1 expression
levels, directly inhibiting the body's natural antitumor immune
response and allowing tumor cells to "escape" the recognition and
attack by the immune system. Currently, five monoclonal antibody
drugs targeting PD-1 or PD-L1 have been approved globally. In
China, there are more anti-PD-1
targeting drugs being developed than anti-PD-L1. As such, clinical
study of CS1001, the first fully human, full-length anti-PD-L1
monoclonal antibody in China, has
significant scientific and therapeutic value.
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SOURCE CStone Pharmaceuticals