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March 25, 2022, Shanghai, China
.
Jimin Trust Group announced that the new drug clinical trial application (IND) submitted by its subsidiary Jiangsu Jiye Biopharmaceutical Co.
, Ltd.
for a new anti-IgE recombinant humanized monoclonal antibody targeted therapy drug JYB1904 injection has been approved by the National Medical Products Administration of China.
approved by the Center for Drug Evaluation (CDE)
.
Approval diagram JYB1904 was independently developed by Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
, a subsidiary of Jimin Trust.
It is a new type 1 biological product with independent intellectual property rights.
The clinical trial application was accepted by CDE on January 14, 2022, and it was obtained in only 70 days.
Implied License for Clinical Trials
.
IgE is the main immunoglobulin that mediates type I hypersensitivity disease.
When the body is exposed to allergens, the allergens can bind to IgE bound to the surface of effector cells FcεRI and cross-link each other to form cross-links, causing inflammatory mediators.
release, leading to various allergic symptoms [1,2]
.
Jimin Trust researchers found that JYB1904 can specifically bind to free IgE, thereby blocking the binding of IgE to its receptor FcεRI, thereby preventing it from being activated by allergens, and is expected to rapidly and effectively relieve the symptoms of patients clinically
.
Mechanism of Action In preclinical studies comparing head-to-head with omalizumab, JYB1904 showed better biological activity, druggability and stability, fast onset, good efficacy in animal asthma models, and in vivo safety in animals Well, the serum half-life of the drug is long [3]
.
These findings indicate that JYB1904 injection has excellent clinical therapeutic potential and can provide a potential new solution for the clinical treatment of moderate to severe asthma and other allergic diseases
.
At present, Jimin Trust has completed the domestic clinical research plan of JYB1904 in order to rapidly advance the clinical phase I trial
.
Looking forward to the product's early release, bringing good news to patients
.
▌About Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
is a wholly-owned subsidiary of Jimin Trust Group and is committed to becoming a drug research and development center with global influence.
Small molecule innovative drugs, innovative traditional Chinese medicines, complex generics and high-end preparations are committed to making breakthroughs in the therapeutic fields of kidney disease, tumor, cardiovascular and cerebrovascular, respiratory system, anti-infection, pediatrics, pain and other therapeutic fields
.
The research and development of JYB1904 injection is led by the company's Macromolecular Innovative Drug Research Institute.
The institute has built a 70 billion-level Fijian fully human antibody library, and independently developed the Feitai antibody discovery platform.
Several antibody drugs have entered the market.
IND or IND filing preparation stage
.
At present, the new coronavirus neutralizing antibody JMB2002 independently developed by the hospital has completed Phase I clinical trials.
The latest research has confirmed that it has a good neutralizing function against the new coronavirus Omicron variant.
The relevant results have been published in Science
.
▌About Jimin Trusted Group Jimin Trusted Group was founded in 1999 and is headquartered in Nanchang, China.
Its main product pipelines are in five areas: kidney disease, tumor, cardiovascular and cerebrovascular, respiratory anti-infection, and pain.
It is committed to providing patients with high-quality products.
Pharmaceuticals and innovative pharmaceutical solutions
.
As one of the leading large-scale modern pharmaceutical groups in China, Jimin Trust Group has been ranked among the top 100 in China's pharmaceutical industry for many consecutive years
.
For more information visit: or contact: PR@jemincare.
com References 1.
Wright JD, Chu HM, Huang CH, Ma C, Chang TW, Lim C.
Structural and Physical Basis for Anti-IgE Therapy .
Scientific reports.
2015; 5:11581.
2.
Palomares O, Akdis M, Martin-Fontecha M, Akdis CA.
Mechanisms of immune regulation in allergic diseases: the role of regulatory T and B cells.
Immunological reviews.
2017; 278(1) :219-36.
3.
Liu P, Pan Z, Gu C, Cao X.
Liu X, Zhang J, Xiao Z, Wang X, Guo H, Ju D, Deng SJ.
An omalizumab biobetter antibody with improved stability and efficacy for the treatment of allergic diseases.
Frontiers in Immunology.
2020;11:1-15.
.
Jimin Trust Group announced that the new drug clinical trial application (IND) submitted by its subsidiary Jiangsu Jiye Biopharmaceutical Co.
, Ltd.
for a new anti-IgE recombinant humanized monoclonal antibody targeted therapy drug JYB1904 injection has been approved by the National Medical Products Administration of China.
approved by the Center for Drug Evaluation (CDE)
.
Approval diagram JYB1904 was independently developed by Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
, a subsidiary of Jimin Trust.
It is a new type 1 biological product with independent intellectual property rights.
The clinical trial application was accepted by CDE on January 14, 2022, and it was obtained in only 70 days.
Implied License for Clinical Trials
.
IgE is the main immunoglobulin that mediates type I hypersensitivity disease.
When the body is exposed to allergens, the allergens can bind to IgE bound to the surface of effector cells FcεRI and cross-link each other to form cross-links, causing inflammatory mediators.
release, leading to various allergic symptoms [1,2]
.
Jimin Trust researchers found that JYB1904 can specifically bind to free IgE, thereby blocking the binding of IgE to its receptor FcεRI, thereby preventing it from being activated by allergens, and is expected to rapidly and effectively relieve the symptoms of patients clinically
.
Mechanism of Action In preclinical studies comparing head-to-head with omalizumab, JYB1904 showed better biological activity, druggability and stability, fast onset, good efficacy in animal asthma models, and in vivo safety in animals Well, the serum half-life of the drug is long [3]
.
These findings indicate that JYB1904 injection has excellent clinical therapeutic potential and can provide a potential new solution for the clinical treatment of moderate to severe asthma and other allergic diseases
.
At present, Jimin Trust has completed the domestic clinical research plan of JYB1904 in order to rapidly advance the clinical phase I trial
.
Looking forward to the product's early release, bringing good news to patients
.
▌About Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
Shanghai Jiyu Pharmaceutical Technology Co.
, Ltd.
is a wholly-owned subsidiary of Jimin Trust Group and is committed to becoming a drug research and development center with global influence.
Small molecule innovative drugs, innovative traditional Chinese medicines, complex generics and high-end preparations are committed to making breakthroughs in the therapeutic fields of kidney disease, tumor, cardiovascular and cerebrovascular, respiratory system, anti-infection, pediatrics, pain and other therapeutic fields
.
The research and development of JYB1904 injection is led by the company's Macromolecular Innovative Drug Research Institute.
The institute has built a 70 billion-level Fijian fully human antibody library, and independently developed the Feitai antibody discovery platform.
Several antibody drugs have entered the market.
IND or IND filing preparation stage
.
At present, the new coronavirus neutralizing antibody JMB2002 independently developed by the hospital has completed Phase I clinical trials.
The latest research has confirmed that it has a good neutralizing function against the new coronavirus Omicron variant.
The relevant results have been published in Science
.
▌About Jimin Trusted Group Jimin Trusted Group was founded in 1999 and is headquartered in Nanchang, China.
Its main product pipelines are in five areas: kidney disease, tumor, cardiovascular and cerebrovascular, respiratory anti-infection, and pain.
It is committed to providing patients with high-quality products.
Pharmaceuticals and innovative pharmaceutical solutions
.
As one of the leading large-scale modern pharmaceutical groups in China, Jimin Trust Group has been ranked among the top 100 in China's pharmaceutical industry for many consecutive years
.
For more information visit: or contact: PR@jemincare.
com References 1.
Wright JD, Chu HM, Huang CH, Ma C, Chang TW, Lim C.
Structural and Physical Basis for Anti-IgE Therapy .
Scientific reports.
2015; 5:11581.
2.
Palomares O, Akdis M, Martin-Fontecha M, Akdis CA.
Mechanisms of immune regulation in allergic diseases: the role of regulatory T and B cells.
Immunological reviews.
2017; 278(1) :219-36.
3.
Liu P, Pan Z, Gu C, Cao X.
Liu X, Zhang J, Xiao Z, Wang X, Guo H, Ju D, Deng SJ.
An omalizumab biobetter antibody with improved stability and efficacy for the treatment of allergic diseases.
Frontiers in Immunology.
2020;11:1-15.
