Http://china.chemnet.com/2022-03-30 09:27:27 xinhua finance
On March 25, 2022, Jemincare Group announced in Shanghai that the clinical trial application (IND) for JYB1904 Injection, a novel anti-IgE recombinant humanized monoclonal antibody targeted therapy submitted by jiangsu Jiye Biopharmaceutical Co., LTD., a subsidiary of Jemincare Group, has been approved by the Drug Evaluation Center (CDE) of the State Food and Drug Administration of China.
JYB1904 is independently developed by Shanghai Jiyu Pharmaceutical Technology Co., LTD., a subsidiary of Jemincare, and is a class 1 new drug of biological products with independent intellectual property rights. The application for clinical trial was accepted by CDE on January 14, 2022, and the tacit approval for clinical trial was obtained in only 70 days.
IgE is the main immunoglobulin mediating type I hypersensitivity disease. When the body is exposed to the allergen, the allergen can bind to the IgE binding on the effector cell surface FcεRI and cross-link with each other to form crosslinking, causing the release of inflammatory mediators and leading to various allergic symptoms.JYB1904 can specifically bind to free IgE, thereby blocking the binding of IgE to its receptor FcεRI, thereby preventing its activation by allergens, which is expected to relieve symptoms of patients quickly and effectively in clinical practice.
In preclinical studies, JYB1904 showed better bioactivity, pharmacodynamics, and stability compared with omalzumab head to head, with rapid onset and good efficacy in animal models of asthma, good safety in animals, and long serum half-life.These results indicate that JYB1904 injection has excellent clinical therapeutic potential and can provide a potential new treatment for moderate and severe asthma and other allergic diseases.
At present, Jemincare has completed the domestic clinical study plan of JYB1904, so as to rapidly advance the clinical phase I trial.We look forward to the early arrival of the product to bring good news to patients.
Shanghai Jiyu Pharmaceutical Technology Co., LTD., a wholly-owned subsidiary of Jemincare Group, is committed to becoming a drug R&D center with global influence. Its R&D pipeline covers innovative drugs of biological macromolecules, innovative drugs of chemical small molecules, innovative Traditional Chinese medicine, complex imitation and high-end preparation. It is committed to making breakthroughs in the treatment of nephropathy, tumor, cardio-cerebrovascular, respiratory system, anti-infection, pediatrics, pain and other fields.The research and development of JYB1904 injection is led by the Institute of Large Molecule Innovative Drugs of the company. The institute has its own human antibody library of 70 billion grade FeiJie and independently developed feiTai antibody discovery platform. Several antibody drugs have entered the IND or IND application preparation stage.At present, JMB2002, a novel coronavirus Omicron neutralizing antibody independently developed by the hospital, has completed phase I clinical trial. The latest study confirmed that JMB2002 has good neutralizing function against novel coronavirus Omicron variant, and relevant results have been published in Science.
Jemincare Group was founded in 1999, headquartered in Nanchang, China, the main product pipeline for kidney disease, tumor, cardio-cerebrovascular, respiratory anti-infection, pain five areas, is committed to providing patients with high-quality drugs and innovative pharmaceutical solutions.As one of the leading modern pharmaceutical groups in China, Jemincare Group has been ranked among the top ten of China's pharmaceutical industry for many consecutive years.
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