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Dongfang Baitai obtained another clinical approval document for anticancer drugs
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Dongfang Baitai obtained another clinical approval document for anticancer drugs

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:779

(Summary description)At the end of July 2018, the McAb drug "Recombinant anti VEGF R2 whole human monoclonal antibody injection" JY025 independently developed by Dongfang Baitai was approved by the State Food and Drug Administration (CFDA). The approved clinical indications are non-small cell lung cancer, gastric cancer and liver cancer.

Dongfang Baitai obtained another clinical approval document for anticancer drugs

(Summary description)At the end of July 2018, the McAb drug "Recombinant anti VEGF R2 whole human monoclonal antibody injection" JY025 independently developed by Dongfang Baitai was approved by the State Food and Drug Administration (CFDA). The approved clinical indications are non-small cell lung cancer, gastric cancer and liver cancer.

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:779
Information

At the end of July 2018, the McAb drug "Recombinant anti VEGF R2 whole human monoclonal antibody injection" JY025 independently developed by Dongfang Baitai was approved by the State Food and Drug Administration (CFDA). The approved clinical indications are non-small cell lung cancer, gastric cancer and liver cancer.

 

 

In recent years, Dongfang Baitai has obtained six clinical approvals successively. In addition to the approved recombinant anti-VEGFR2 all-human monoclonal antibody JY025, there are new therapeutic EGF vaccine, Exendin-4 fusion protein JY09 for long-term treatment of type II diabetes, recombinant humanized anti-VEGF antibody JY028 for metastatic colorectal cancer and non-small cell lung cancer, recombinant humanized anti-VEGF antibody for AMD and anti-TNF-α all-human antibody drug JY026. Six clinical approval documents mainly involve four major treatment areas: tumor, endocrine, autoimmune diseases and ophthalmic diseases, and the results were fruitful.

 

Significance of VEGFR2 target

Tumor is one of the major diseases threatening human life and health. At present, the research of anti-tumor drugs shows a trend of diversified development. Angiogenesis is the key process of tumor growth. VEGF - VEGFR signal system is the key signal pathway of tumor angiogenesis. Taking VEGF/VEGFR as a target to inhibit tumor by inhibiting tumor angiogenesis has become an important field in anti-tumor research.

 

 

VEGFR2 (vascular endothelial growth factor receptor) is a tyrosine kinase receptor and the most important signal transduction molecule of VEGF mediated angiogenesis. VEGFR2 is up-regulated in some solid tumors and plays an important role in tumor angiogenesis. Therefore, the vast majority of inhibitors (drugs) targeting VEGF/VEGFR are actually targeting the VEGF/VEGFR2 signal pathway. The development of drugs targeting VEGFR2 has been recognized as an important and effective anti-cancer model. It has important significance in the treatment of tumor and other diseases.

 

Malignant Tumor Becomes a Health "Killer"

At present, malignant tumor has become one of the main causes of death in China. According to the prediction of the International Agency for Research on Cancer, if effective measures are not taken, the number of cancer cases and deaths in China will rise to 4 million and 3 million by 2020. It will increase to 5 million and 3.5 million in 2030.

According to the statistics of the National Cancer Center, among the patients with malignant tumors in China, the incidence rate of male patients with lung cancer, stomach cancer and liver cancer has respectively occupied the top three places. The incidence rate of female patients also occupies the second, fourth and seventh place respectively. The situation is urgent.

 

 

Equally serious is that the mortality rate of male patients with lung cancer, gastric cancer and liver cancer in China also occupies the first three places respectively. The mortality rate of female patients also occupies the first, second and fourth place respectively. The situation is not optimistic.

 

 

It can be said that among the malignant tumors in China, lung cancer, gastric cancer and liver cancer are the three leading malignant tumors. It has brought great harm to the life and health of our people and social stability. It is urgent to develop monoclonal antibody drugs with clinical value to improve the status quo. The development of monoclonal antibodies against VEGFR2 can meet the unmet needs of anti-tumor drugs in China.

 

The only VEGFR2 monoclonal antibody in the world

In April 2014, FDA approved Remorumab of Lilly for the treatment of advanced gastric cancer or adenocarcinoma of gastroesophageal junction. The trade name is Cyramza. The Chinese name is ramorumab. This drug is the only VEGFR2 monoclonal antibody that has been marketed in the world so far. However, there is no similar drug with the same target in China (excluding Hong Kong, Macao and Taiwan). In 2016, Remolumab created sales of US $614 million for Lilly, with a year-on-year growth of more than 60%. At present, the indications of ramorumab increase colorectal cancer and non-small cell lung cancer.

 

 

Dongfang Baitai seizes the commanding heights of new drug research and development

VEGFR2 target is a global hot target. At present, there is no new anti McAb drug on the market in China. Among the local pharmaceutical enterprises preparing for the battle against VEGFR2 monoclonal antibody, Dongfang Baitai is in a leading position.

JY025 is a Class 1 innovative therapeutic biological product independently developed by Dongfang Baitai. The drug molecule has been protected by the invention patent authorized by the State Intellectual Property Office. It has independent intellectual property rights. The pharmacodynamic study showed that JY025 had good safety, biological activity and affinity in vitro and in vivo. It is mainly used to treat adult patients with advanced gastric cancer or liver cancer after chemotherapy. It has great potential clinical application prospects. After obtaining the approval, we will accelerate the promotion of clinical projects and produce high-end biological drugs that can be used and affordable by Chinese people as soon as possible.

 

 

Pharmacological action and mechanism of JY025

Vascular endothelial growth factor (VEGF) is a key regulator of neovascularization related to tumors and intraocular diseases. VEGFR2 (vascular endothelial growth factor receptor) is a tyrosine kinase receptor. It is also the most important signal transduction molecule of VEGF mediated angiogenesis. JY025 is an all human monoclonal antibody against VEGFR2. It can specifically bind to human VEGFR2 (KDR), block the binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D with receptors, and reduce tumor angiogenesis. It can inhibit the growth, invasion and migration of tumor cells.

 

About Dongfang Baitai

In the future, Dongfang Baitai will continue to take developing China's bio medicine and improving people's health as its own responsibility. We adhere to the core values of "responsibility, quality, innovation and health", constantly improve our independent innovation ability, and serve the pharmaceutical industry with the latest achievements of biotechnology development. We will dedicate advanced, safe and effective drugs to the majority of patients, and look forward to working with you to create a tomorrow of biomedicine!

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