SHENZHEN, China, April 30,
2024 /PRNewswire/ -- Shenzhen Chipscreen Biosciences
Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH)
announced that the company's lead innovative product Chidamide
(Epidaza®) , an oral subtype-selective histone deacetylase (HDAC)
inhibitor, combined with R-CHOP (rituximab, cyclophosphamide,
doxorubicin, vincristine, and prednisone), has been officially
approved by the National Medical Products Administration (NMPA) for
treatment of previously untreated diffuse large B-cell lymphoma
(DLBCL) with positive MYC and BCL2 expression. Up to now, Chidamide
has been approved for multiple indications globally. (For more
information, please review the global commercialization
situation).
Diffuse large B-cell lymphoma (DLBCL) is the most common type of
lymphoma, with approximately 30000 new cases occurring annually in
China. Clinical diagnosis and
treatment guidelines and consensus both domestically and
internationally recommend the R-CHOP regimen as the standard
first-line treatment for DLBCL. However, about one-third or more of
patients in the overall population still experience ineffective or
early recurrence of first-line R-CHOP treatment. Meanwhile,
approximately 30% of patients with DLBCL exhibit simultaneous
overexpression of MYC/BCL2 protein (referred to as "double
expression" lymphoma, DEL), and their efficacy and prognosis after
R-CHOP treatment are significantly lower than those of non double
expression patients. Therefore, how to combine new drugs based on
R-CHOP regimen to provide a more effective and safer treatment to
our patients is a significant unmet medical need.
The approval of this new indication is based on a randomized,
double-blind, placebo-controlled, multicenter Phase III clinical
trial DEB trial (NCT04231448). The DEB trial is the first Phase III
registered clinical study in the world as first line treatment of
MYC/BCL2 dual expression diffuse large B-cell lymphoma. This trial
is to evaluate the efficacy and safety of Chidamide combined with
R-CHOP compared to R-CHOP in primary treatment and MYC/BCL2 dual
expression DLBCL subjects. Based on the interim analysis conducted
by the Independent Data Monitoring Committee (iDMC), the efficacy
and safety indicators set by the protocol were achieved. Compared
with the R-CHOP regimen, the Chidamide combination regimen
significantly improved the complete response rate (CRR) of the
study's key secondary endpoint, and the study's primary endpoint,
event free survival (EFS), also showed a clear trend of benefit.
The experimental safety profile is consistent with known risks, and
no new significant safety signals were found. The results of the
interim analysis of the DEB Phase III study were selected as the
Late breaking Abstract (LBA) for the American Society of Clinical
Oncology (ASCO) Annual Meeting on April 24,
2024.
Dr. Xianping Lu, Chairman and
General Manager of Chipscreen Biosciences, stated, "The classic
R-CHOP regimen has been used as a first-line treatment for diffuse
large B-cell lymphoma (DLBCL) for nearly 20 years, but its
therapeutic effect is not satisfactory in populations with dual
expression of BCL2 and MYC proteins. The combination of Chidamide
and R-CHOP is the world's first phase 3 registered clinical study
that focuses on first line therapy of dual expressed DLBCL, and
also the world's first R-CHOP improvement study with significant
benefits in complete remission rate. We believe that the approval
of the new indication will bring new hope and better survival
benefits to patients."
About Chidamide (Epidaza®)
Chidamide (Tucidinostat, Trade name: Epidaza®), a Class 1.1
innovative drug, is a novel molecular entity with global patent
protection and the first marketed product developed independently
by Chipscreen Biosciences. The first original chemical new drug
approved in China, Chidamide is
also the first oral subtype-selective histone deacetylase (HDAC)
inhibitor in the world, Since its approval in China in December
2014 for the treatment of peripheral T-cell lymphoma,
Chidamide has achieved significant commercialization worldwide and
continuously explored new indications.
Global commercialization situation:
- In December 2014, Chidamide was approved for use in
patients with recurrent or refractory peripheral T-cell lymphoma
(PTCL) in China;
- In November 2019, Chidamide was approved to combine
aromatase inhibitors to treat locally advanced or metastatic breast
cancer patients with estrogen receptor positive, human epidermal
growth factor receptor-2 negative, postmenopausal, and endocrine
therapy relapse or progress in China;
- In June 2021, Chidamide was
approved for monotherapy in the treatment of recurrent or
refractory (R/R) adult T-cell leukemia (ATL) in Japan;
- In December 2021,
Chidamide was approved for monotherapy for recurrent or
refractory (R/R) peripheral T-cell lymphoma (PTCL) in Japan;
- In March 2023, Chidamide was
approved to be used for postmenopausal women with locally advanced
or metastatic breast cancer who are hormone receptor positive, type
II human epidermal growth factor receptor (HER2) negative, and
relapse or worsen after endocrine therapy (in combination with
exemestane) in Taiwan,
China;
- In April 30, 2024,
Chidamide was approved to use in combination with R-CHOP
(rituximab, cyclophosphamide, doxorubicin, vincristine, and
prednisone) for previously untreated diffuse large B-cell lymphoma
(DLBCL) patients with positive MYC and BCL2 expression in
China.
Global exploration of other indications:
- In addition to ongoing global multicenter phase III clinical
trial for the first-line treatment of melanoma in comniation with
Opdivo, Chidamide is also conducting multiple clinical trials
in China and internationally
in combination with different anti-tumor
immunotherapies.
- In November 2023, the Phase II
clinical trial of the first-line treatment of non-small cell lung
cancer with Chidamide combined with Tislelizumab was completed and
enrolled.
- On March 4, 2024,
Professor Ruihua Xu and Professor Feng
Wang from the Cancer Prevention and Treatment Center of
Sun Yat sen University led the
research on CAPAbility-01, which was published on the world's
top academic journal Nature Medicine (IF=82.9). As one of the most
valuable sub journals under Nature, the publication of Nature
Medicine reflects the academic authority's recognition of
CAPAbility-01 research. This study indicates that for patients with
microsatellite stable/mismatched repair function intact (MSS/pMMR)
type metastatic colorectal cancer (mCRC), a three drug regimen led
by Chidamide (Chidamide+sintilimab antibody+bevacizumab) for
third line and above treatment, with an 18 week PFS rate of 64.0%,
an ORR of 44.0%, and a median PFS of 7.3 months, is considered a
promising treatment option for MSS/pMMR advanced CRC patients.
- On April 24, 2024, an abstract
entitled "Tucidinostat plus R-CHOP in previously untreated diffuse
large B-cell lymphoma with double expression of MYC and BCL2: An
interim analysis from the phase III DEB study" was selected the
American Society of Clinical Oncology (ASCO) LBA list for the 2024
ASCO, which submitted by Professor Weili
Zhao's team from Ruijin Hospital affiliated with Shanghai
Jiao Tong University School of Medicine
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. Our complete industry chain that
covers early exploratory discovery through commercialization allows
us to provide innovative Chinese drugs for patients worldwide.
With a global development strategy based on early-stage research
in China, Chipscreen Biosciences
has leveraged the top scientists and teams with extensive
experience in related fields from the Shenzhen Small Molecule Early
R&D Center and Chengdu Small Molecule Early R&D Center to
create an integrated technology platform based on AI-driven design
and chemical genomics, which spanned the whole process from basic
science to clinical translation. We have successfully developed
first-in-class and best-in-class innovative drugs. Currently, we
have marketed two drugs for threeindications 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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