SHANGHAI, June 25,
2022 /PRNewswire/ -- On June
15, 2022, Dragon Boat announced that its IND application of
the innovative anti-CLDN 18.2/CD47 bi-specific antibody (bsAb)
injection (R&D code: BC007) was officially accepted by National
Medical Products Administration (NMPA) under the acceptance number
CXSL2200267. This drug is the first domestic clinical filing of the
CLDN 18.2/ CD47 bsAb, which is intended for the treatment of late
stage solid tumors.
Acceptance
No.
|
Drug
Name
|
Drug Type
|
Application
Type
|
Registration
Category
|
Company
|
Date
|
CXSL2200267
|
BC007
antibody injection
|
Therapeutic
biological
products
|
Pharmaceutics
|
1
|
Dragon Boat
Biopharmaceutical
(Shanghai)
|
2022-06-14
|
BC007 is a innovative bsAb targeting CLDN 18.2 and CD47 and the
early-stage development was completed collaboratively by Sanyou and
Dragon Boat. Validation results of the in vivo efficacy
showed that BC007 exhibited dose-dependent anti-tumor effects
against CLDN18.2 overexpressing CDX mouse models of human gastric
cancer, human pancreatic cancer and human colon cancer, and was
significantly better than the selected comparator antibody. In the
safety studies, hematological toxicity is one of the common
challenges of CD47 targeting antibodies. But in the cynomolgus
monkey toxicity study, multiple doses of BC007 was administered for
5 weeks without animal death, and the hematological toxicity was
mild and well tolerated by the animals.
In March this year, the IND application of anti-CLDN 18.2
antibody injection (BC008) developed by Dragon Boat has been
approved by National Medical Products Administration. In the
future, Dragon Boat will bring greater clinical benefits to the
patients by exploring more treatment options.
Dr. Guojun Lang, CEO of Sanyou,
said "We sincerely congratulate Dragon Boat on the NMPA acceptance
of IND application with the CLDN 18.2/CD47 bsAb, which is another
milestone after the clinical approval of the anti-CLDN 18.2
nanoantibody co-developed by Sanyou and Dragon Boat in March. This
project further proves the outstanding competency of Dragon Boat in
the field of innovative biopharmaceutical research and development.
This project is also another successful case of Sanyou's
Cooperative Project Organization (CPO) business model. We wish the
clinical studies will proceed successfully and benefit the patients
as soon as possible".
About CLDN 18.2
Tight junction protein claudin-18 isoform 2 (CLDN18.2) is a
member of the claudin family, which includes tight junction
proteins that establish paracellular barriers to control the
molecular passage and motions among cells. Normally, CLDN 18.2 is
expressed only on the surface of differentiated epithelial cells of
the gastric mucosa. However, after the development of malignant
tumors, tight junction proteins are disrupted, exposing the CLDN
18.2 epitope on the surface of tumor cells. Studies have shown high
CLDN 18.2 expression in the tumor cells of 50%-80% of gastric
cancer patients and 60% of pancreatic cancer patients.
About CD47
CD47 is a glycosylated transmembrane protein, a key member of
the immunosuppressive signaling pathway, which inhibits macrophage
phagocytosis and mediates the immune escape mechanism of various
malignant tumors, mainly by interacting with the inhibitory
receptor signal-regulatory protein alpha (SIRPĪ±), which is widely
recognized as a "don't eat me" signal. Numerous studies have shown
that CD47 is overexpressed in different types of tumors, including
myeloma, smooth muscle sarcoma, acute lymphoblastic leukemia, and
non-Hodgkin's lymphoma.
About Dragon Boat Biopharmaceutical
Founded in 2005, Dragon Boat Pharmaceutical is a high-tech
enterprise committed to the research and development of biologics.
Dragon Boat focus on the therapeutic area for gastrointestinal
cancer and are dedicated to bringing novel drugs for treating
oncology and autoimmune disease to global patients. The company was
wholly owned by Guilin Sanjin (002275) since 2013.
Adhering to the concept of independent innovation, Dragon Boat
established a drug R&D center in Zhangjiang high-tech park,
occupying 5,000 square meters, covering early discovery,
preclinical research, IND, clinical research, BLA and
manufacturing. The company's pipeline has 9 biologics candidates,
covering multiple modalities and multiple immune targets. As of
today, 4 of them entered the clinical development stage. With
insistent investment to R&D and excellent drug discovery
capability, Dragon Boat Pharmaceutical became a leading innovative
biotech company in China.
About Sanyou Biopharmaceuticals
Sanyou Biopharmaceuticals Co., Ltd. is a biological high-tech
enterprise focusing on R&D and services of innovative antibody
drugs. Sanyou is committed to establishing a leading high-quality,
high-throughput, integrated R&D and value transformation
platform for innovative antibody drugs internationally,
constructing a business ecosystem involving therapy, R&D, and
diagnostic products and services, and cooperating with global
biopharmaceutical, diagnostic, and drug R&D companies to make a
new progress in the diagnosis and treatment of human diseases.
Sanyou has established an innovative antibody drug integrated
R&D laboratory of over 20,000 square meters with advanced
facilities and equipment, and more than 40 core innovation
technology platforms, including innovative antibody drug discovery
featured with a series of trillion phage display antibody
libraries, innovative antibody drug optimization, cell line
construction, upstream and downstream process development,
preclinical R&D and industrial development.
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