SHENZHEN, China, July 19,
2024 /PRNewswire/ -- On July 19, Shenzhen
Chipscreen Biosciences Co., Ltd. (hereinafter referred to as
"Chipscreen Biosciences") announced that it has received the Drug
Registration Certificate approved and issued by the National
Medical Products Administration (NMPA) for Chiglitazar, a noval
PPAR (Peroxidase Proliferator Activated Receptor) full agonist
developed by the company's independently, combined with Metformin
for the treatment of type 2 diabetes. This is a further expansion
of the clinical application of Chiglitazar after it was approved as
a single agent for the treatment of type 2 diabetes in October 2021, and will provide a noval
therapeutic option of combination for type 2 diabetes patients.
As of 2021, the number of diabetes patients in China has reached 141 million, ranking first
globally. Type 2 diabetes accounts for more than 90% of the total.
As a progressive disease, it seriously affects the quality of life
of patients and causes a heavy burden on society. As the disease
progresses, the probability of monotherapy failure in type 2
diabetic patients gradually increases. Researches have shown that
50% of newly diagnosed T2DM patients require combination therapy
after three years of treatment for patients with initial diabetes;
After 9 years of treatment, 75% of patients require combination
therapy; In addition, for newly treated patients with high blood
glucose levels, such as HbA1c>9%, combination therapy is often
necessary to achieve good glycemic control. Therefore, combination
therapy is essential for diabetes patients.
Insulin resistance, as one of the important pathological
mechanisms of the occurrence and development of type 2 diabetes,
has always been a focus and challenge of drug development and
clinical treatment. It will not only cause hyperglycemia but also
lead to hyperlipidemia, overweight/obesity, fatty liver,
atherosclerotic cardiovascular disease, etc. Now, Chiglitazar has
been approved for adjunction to metformin to improve glycemic
control in patients with type 2 diabetes with poor blood glucose
control after metformin monotherapy. The randomized, double-blind,
placebo-controlled pivotal Phase III clinical trial showed that
compared with placebo combined with metformin, Chiglitazar combined
with metformin can achieve more clinical benefits such as
continuous glucose reduction, blood lipid regulation and
cardiovascular risk reduction, which shows the promising
application of Chiglitazar in combination with diabetes drugs of
different mechanisms.
Dr. Xianping Lu, chairman of
Chipscreen, said: "Although there are multiple drugs available for
the treatment of T2DM, the rapid growth of the number of patients
with diabetes indicates that there are still significant unmet
clinical needs in this field, whether it is monotherapy or
combination therapy. As the first PPAR full agonist approved to
treat type 2 diabetes in the world, Chiglitazar with a new
mechanism of action has broken the long-term dilemma of etiological
treatment of insulin resistance, effectively targeted the metabolic
syndrome caused by metabolic disorder, opening up a new path for
the treatment of type 2 diabetes and providing clinicians and
patients with a more flexible and effective combination drug
regimen.
About Chiglitazar
Chiglitazar (Shuangluoping ®/ Bilessglu ®) is a new mechanism
hypoglycemic drug independently developed by Shenzhen Chipscreen
Biosciences Co., Ltd. As a new chemical molecule，it belongs
to a national Class 1 new drug, national "Major New drug creation" special achievement .
It is the first PPAR full agonist which approved for the treatment
of type 2 diabetes in the world.
Chiglitazar can control blood glucose level and ameliorate
the lipid and energy metabolic disorders that accompany T2DM,
helping to prevent and control cardiovascular complications. This
makes Chiglitazar a potentially more comprehensive treatment option
for T2DM.
Many basic studies have confirmed that insulin resistance is one
of the core pathological mechanisms for the occurrence and
development of type 2 diabetes, and it is also the common soil for
various metabolic abnormalities such as blood sugar and blood
lipid. Insulin resistance will not only cause hyperglycemia, but
also lead to hyperlipidemia, overweight/obesity, fatty liver,
atherosclerotic cardiovascular disease (ASCVD), etc. However, there
are relatively few drug options directly targeting the improvement
of insulin resistance in clinical practice. Chiglitazar, a PPAR
total agonist, can moderately activate three PPAR receptor subtypes
with different functions in regulating glucose, lipid and energy
metabolism in vivo, and selectively changes a series of gene
expressions related to insulin sensitivity, targeting insulin
resistance, the core pathological mechanism of the occurrence and
development of type 2 diabetes. Through improving the sensitivity
of diabetes patients to insulin, regulating blood sugar, improving
their complicated lipid metabolism disorder, potentially reducing
the occurrence and harm of cardiovascular complications, bringing
better efficacy and safety, and achieving comprehensive treatment
of diabetes and its complications. In addition to the indications
for type 2 diabetes, Chiglitazar has also carried out clinical
exploration of compound preparations of diabetes drugs
(metformin-chiglitazar compound, Empagliflozin-chiglitazar
compound) and phase II clinical research of single drug treatment
of nonalcoholic fatty liver steatohepatitis in China.
In October 2021, Chiglitazar was
approved by the National Drug Administration (NMPA) to be marketed
for the treatment of type 2 diabetes.
In January 2023, Chiglitazar was
included in the national medical insurance directory.
In March 2024, the Phase II
clinical trial (CGZ203 study) of Chiglitazar monotherapy for
non-alcoholic steatohepatitis achieved the primary efficacy
endpoint.
In July 2024, the treatment of
type 2 diabetes patients with poor blood glucose control after
single drug treatment of metformin with Chiglitazar and metformin
was approved for marketing by the National Drug Administration
(NMPA) of China.
About Chipscreen
Chipscreen Biosciences is an innovative drug company driven by
core technologies with globally competitive pipelines. As a pioneer
in drug innovation & development in China, adhering to the concept of "Constant
Innovation for Life", we focus on developing revolutionary
innovative drugs with new mechanisms of action, to address
patients' pressing clinical needs. Chipscreen Biosciences has
formed a complete industrial chain covers from early exploratory
discovery to commercialization, providing original Chinese new
drugs for global patients.
Based on the global development strategy of China's early stage research, Chipscreen
Biosciences has been able to open the whole process from basic
research to clinical transformation with Shenzhen Small Molecule
Early R&D Center and Chengdu Small Molecule Early R&D
Center bringing together top scientists and teams with senior
experience in related fields, and applying the integrated
technology platform based on AI-driven design and chemical
genomics. We have successfully developed first-in-class and
best-in-class innovative drugs. Currently, we have marketed two
drugs for four indications in Mainland China, two indications in
Japan, and one indication in
Taiwan, China. In addition, we have launched a number
of R&D projects with differentiated advantages and global
competitiveness in the five major areas, including malignant
tumors, metabolic diseases, autoimmune diseases, central nervous
system diseases, and antivirals.
Chipscreen Biosciences has formed a global industrial layout
consisting of Shenzhen Head Office/R&D Center/GMP production
base, Chengdu Regional Head Office/R&D Center/GMP production
base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences
(USA) Co., Ltd. Meanwhile, as one
of the first batches of national "innovative drug incubation bases"
and national high-tech enterprises, Chipscreen Biosciences has
independently undertaken many national "863" plans and national
major science and technology projects, such as "10th five-year
plan", "11th five-year plan", "12th five-year plan" and "13th
five-year plan", and National Science and Technology primary
Project for Innovative Drug Development. We have filed over 660
invention patents in China and
worldwide, with over 180 granted.
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SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.