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Heavy! Dongfang Bataicumab got another clinical approval!
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Heavy! Dongfang Bataicumab got another clinical approval!

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:926

(Summary description)On May 27, 2017, the monoclonal antibody drug "recombinant humanized anti VEGF monoclonal antibody injection" independently developed by our company obtained the clinical approval issued by the State Food and Drug Administration. The approved clinical indication is wet (neovascular) age-related macular degeneration (AMD).

Heavy! Dongfang Bataicumab got another clinical approval!

(Summary description)On May 27, 2017, the monoclonal antibody drug "recombinant humanized anti VEGF monoclonal antibody injection" independently developed by our company obtained the clinical approval issued by the State Food and Drug Administration. The approved clinical indication is wet (neovascular) age-related macular degeneration (AMD).

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:926
Information

On May 27, 2017, the monoclonal antibody drug "recombinant humanized anti VEGF monoclonal antibody injection" independently developed by our company obtained the clinical approval issued by the State Food and Drug Administration. The approved clinical indication is wet (neovascular) age-related macular degeneration (AMD).

 

 

AMD seriously threatens the health of the elderly

Age related macular degeneration (AMD) is also known as age-related macular degeneration. It is the aging change of macular area structure. Clinically, it can be divided into two types: wet (neovascular) and dry (nonneovascular). Most of them are over 45 years old, which is one of the important causes of blindness in elderly patients. It is the third largest blinding eye disease, which seriously threatens the health of the elderly.

The harm of AMD will seriously affect the life of patients. The loss of vision makes things that were easy to do difficult, and brings great changes to the elderly in their later life. It brings huge physiological and psychological burden to patients and heavy economic burden to patients' families.

 

Huge potential of AMD treatment market

According to a report in 2013, among the five major markets (France, Germany, Italy, Spain and the United Kingdom) in the United States, Japan and Europe in the next 10 years, the drug market for age-related macular degeneration will grow at a compound annual growth rate (CAGR) of 6%. While China is a populous country, the prevalence of AMD among people over 50 years old in China is 1.89%~15.5%. The incidence rate of mental workers in cities is high. The incidence rate of the elderly over 70 years old was 11.19%. The risk of disease increases significantly with age.

With the acceleration of China's aging population and the direct impact of blue light from electronic video screens and mobile phone LED screens on the eyes, the macular area of the eyes has been damaged and accelerated to varying degrees. The disease has an obvious upward trend. The treatment of wet AMD includes traditional laser photocoagulation, radiotherapy, anti-oxidation treatment, removal of neovascular membrane, retinal pigment epithelium transplantation, macular transposition and other surgical methods, as well as photodynamic therapy, which is popular in recent years. Because of the limited scope of application, high recurrence rate and some serious complications, they could not achieve a good therapeutic effect.

 

Market status of wet AMD antibody drugs

With the continuous elucidation of the pathological mechanism of AMD, choroidal neovascularization as the main pathogenesis of wet AMD has been widely recognized, and antibody drugs targeting angiogenesis will have great market potential. Vascular endothelial growth factor (VEGF) plays an important role in promoting angiogenesis. Drugs targeting VEGF targets have been widely used in the treatment of wet AMD.

At present, the clinical drugs for the treatment of wet AMD targeting VEGF in the world include Bevacizumab of Roche, Lucentis of Roche/Novartis, and Aflibercept of Regenerator. Bevacumab has not been approved by FDA for the treatment of wet AMD. However, the clinical application data of super indications show that its efficacy in treating wet AMD is no less than that of other drugs with the same target. It has become a new hot spot in the treatment of wet AMD at home and abroad.

 

 

Take the lead in launching domestic clinical research on wet AMD

The "recombinant humanized anti VEGF monoclonal antibody injection" independently developed by our company is a biological analog of bevacizumab. Previously, the drug has obtained the clinical research approval for metastatic colorectal cancer and non-small cell lung cancer, and is undergoing Phase I clinical treatment. The approval of the clinical trial of wet AMD indication means that Dongfang Baitai will become a leading enterprise in developing bevacizumab to treat wet AMD in China.

Although there are many kinds of biological drugs used to treat wet AMD in the world. However, the vast majority of drugs on the market are too expensive for patients to afford. Dongfang Baitai will seize the leading advantage of this drug in the first clinical approval in China and actively carry out clinical work. If the achievement transformation is realized successfully, the huge gap of clinical medication for wet AMD patients will be filled with its relatively friendly price, good efficacy and low side effects. It brings a new dawn for the treatment of patients with ophthalmic diseases in China. At the same time, on the basis of improving the company's core competitiveness and sustainable development, it will also play a positive role in promoting the development of China's biomedical industry. It has great social and economic benefits.

 

Pharmacological action and mechanism

Recombinant humanized anti VEGF monoclonal antibody is produced in mammalian cell (CHO) expression system through genetic engineering technology. It can be used to treat wet (neovascular) age-related macular degeneration (AMD). This product has high affinity with VEGF and inhibits the binding of VEGF with its receptors VEGFR1 and VEGFR2. VEGF binding to its receptor can lead to the proliferation of vascular endothelial cells, angiogenesis and increase vascular permeability. These are believed to be associated with the progression of neovascular age-related macular degeneration (AMD).

 

Dongfang Baitai

At present, biotechnology drugs are the hotspot and key field of global drug research and development. Dongfang Baitai has started the research and development of biotechnology drugs for many years. The company has made full use of its own advantages to combine innovation and imitation, and has successively set up projects to research and develop more than 20 biotechnology drugs. It covers many disease fields such as tumor, diabetes, autoimmune and ophthalmic diseases. It is estimated that many new varieties of monoclonal antibodies will be applied for clinical use in 2017.

Dongfang Baitai will continue to strengthen the development of biotechnology drugs and devote itself to becoming a leading large pharmaceutical enterprise in China. In order to improve the market share and competitiveness of China's antibody drugs in the international advanced antibody drugs, and make unremitting efforts to establish a bio pharmaceutical innovative enterprise attracting global attention!

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