Dongfang Baitai anti-cancer drug has obtained clinical approval!
- Categories:Company News
- Author:
- Origin:Dongfang Baitai
- Time of issue:2022-05-23
- Views:669
(Summary description)Beijing Dongfang Baitai Biotechnology Co., Ltd. is a cutting-edge biotechnology company focusing on the research and development of humanized monoclonal antibodies. The anti VEGF humanized antibody JY028, the company's product under research, has recently obtained the approval document for drug clinical trials issued by the State Food and Drug Administration (CFDA). It means that the anti-cancer drugs of Dongfang Baitai can officially carry out clinical research in China, which is an important step for the product to go on the market. This is another major breakthrough of Dongfang Baitai after obtaining the clinical approval document of long-acting diabetes biological drug JY09.
Dongfang Baitai anti-cancer drug has obtained clinical approval!
(Summary description)Beijing Dongfang Baitai Biotechnology Co., Ltd. is a cutting-edge biotechnology company focusing on the research and development of humanized monoclonal antibodies. The anti VEGF humanized antibody JY028, the company's product under research, has recently obtained the approval document for drug clinical trials issued by the State Food and Drug Administration (CFDA). It means that the anti-cancer drugs of Dongfang Baitai can officially carry out clinical research in China, which is an important step for the product to go on the market. This is another major breakthrough of Dongfang Baitai after obtaining the clinical approval document of long-acting diabetes biological drug JY09.
- Categories:Company News
- Author:
- Origin:Dongfang Baitai
- Time of issue:2022-05-23
- Views:669
Beijing Dongfang Baitai Biotechnology Co., Ltd. is a cutting-edge biotechnology company focusing on the research and development of humanized monoclonal antibodies. The anti VEGF humanized antibody JY028, the company's product under research, has recently obtained the approval document for drug clinical trials issued by the State Food and Drug Administration (CFDA). It means that the anti-cancer drugs of Dongfang Baitai can officially carry out clinical research in China, which is an important step for the product to go on the market. This is another major breakthrough of Dongfang Baitai after obtaining the clinical approval document of long-acting diabetes biological drug JY09.
01. About JY028
Bioanalogs
JY028 is a vascular endothelial growth factor (VEGF) inhibitor, which belongs to biologically similar drugs.
Action mechanism
It can specifically bind to VEGF. Thus, VEGF can be blocked from binding to its receptors in endothelial cells (Flt-1 and KDR). It can inhibit tumor angiogenesis, tumor growth and metastasis.
JY028 Action Mechanism Diagram
Indication
The approved indications of the drug are metastatic colorectal cancer and non-small cell lung cancer.
02. About JY028 original drug bevacizumab
Research and market situation of drugs at home and abroad
The original drug Avastin of JY028 was developed by Genentech (a subsidiary of Roche), which is the first anti angiogenic drug in the world.
It was approved by the US Food and Drug Administration (FDA) for the first time in February 2004.
Approved by the European Medicines Agency (EMA) in January 2005;
In August 2007, it was approved by the Japanese Pharmaceutical and Medical Device Agency (PMDA);
In February 2010, it was approved for listing by China Food and Drug Administration (CFDA).
It has been approved for cancer treatment in more than 120 countries.
Bevaczumab has been among the top ten single drug sales in the world since 2012. The sales volume in 2016 was nearly 7 billion dollars. It ranks sixth in the global single drug sales ranking. It ranks 4th in the global antibody drug ranking. The international market is strong and the domestic market capacity is huge.
Numerous indications
Since its debut in the United States in 2004, bevacizumab has been internationally approved for the treatment of metastatic colorectal cancer, non-small cell lung cancer, malignant glioma, cervical cancer, recurrent ovarian, fallopian tube or primary peritoneal cancer. It includes many solid tumors.
Patent is about to expire
Bevacizumab entered the chinese market and was approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer. The drug patent will expire in 2019. It has become one of the most popular targets for the development of biological analogues in China.
03. JY028 Huge Market Demand
Large number of patients
The number of new cancer patients in China is increasing year by year. In 2015 alone, there were more than 4 million new cases of invasive cancer. There are more than 2.8 million cancer deaths. Lung cancer, colorectal cancer, kidney cancer, breast cancer and other cancers are the tumors with the highest incidence rate and the first cause of cancer death.
Imported drugs are expensive
At present, most of the targeted drugs for the treatment of these solid tumors in China are imported from abroad. Its high price will bring heavy economic burden to cancer patients.
Urgent need for domestic drugs
With the expiration of domestic and international patents, bevacizumab has become one of the hottest targets for the development of biological analogues in China and even in the world. With the vigorous development of biological analogues, more patients will benefit from the continuous listing of this variety of biological analogues.
Dongfang Baitai has a leading antibody drug research and development and production team. The developed JY028 is highly similar to bevacizumab. The experimental results show that its efficacy and safety are very good. The JY028 project focuses on the global market while expanding the domestic market, especially by virtue of good cooperation with South American countries to expand the South American market. We have reason to believe that JY028 will occupy its unique position in the fierce competition in the future biological analogues market.
04. About Dongfang Baitai
Beijing Dongfang Baitai Biotechnology Co., Ltd. is located in Yizhuang Park, Zhongguancun. The company covers an area of nearly 60000 square meters. It is a high-tech enterprise engaged in innovative antibody R&D and production. It mainly focuses on new products of major disease treatment and preventive biological medicine.
The company has an international professional antibody research and development team of hundreds of people. An industrial technology platform featuring original antibody drugs and new vaccines with advanced level and integrated research and production has been built. Nearly 20 R&D pipelines have been deployed in tumor, diabetes and autoimmune diseases. It is estimated that another blockbuster antibody drug will be approved in 2017. At the same time, 2-3 varieties will be applied for clinical treatment. Dongfang Baitai will always make outstanding contributions to the prevention and treatment of major diseases in China, as well as the promotion of China's biological medicine innovation ability and rapid development of industrialization.
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