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Double happiness! Dongfang Baitai adalimumab Bio-similar Drugs Obtained Clinical Approval!
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Double happiness! Dongfang Baitai adalimumab Bio-similar Drugs Obtained Clinical Approval!

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:845

(Summary description)Two products of Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as " Dongfang Baitai"), anti-vascular endothelial growth factor (VEGF) humanized antibody medicine JY028 and anti-tumor necrosis factor-α (TNF-α) all-human antibody medicine JY026, have been approved by china food and drug administration (CFDA) for clinical trials within half a month. It can be described as double happiness! At present, JY09, JY028 and JY026 have entered clinical research.

Double happiness! Dongfang Baitai adalimumab Bio-similar Drugs Obtained Clinical Approval!

(Summary description)Two products of Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as " Dongfang Baitai"), anti-vascular endothelial growth factor (VEGF) humanized antibody medicine JY028 and anti-tumor necrosis factor-α (TNF-α) all-human antibody medicine JY026, have been approved by china food and drug administration (CFDA) for clinical trials within half a month. It can be described as double happiness! At present, JY09, JY028 and JY026 have entered clinical research.

  • Categories:Company News
  • Author:
  • Origin:Dongfang Baitai
  • Time of issue:2022-05-23
  • Views:845
Information

Two products of Beijing Dongfang Baitai Biotechnology Co., Ltd. (hereinafter referred to as " Dongfang Baitai"), anti-vascular endothelial growth factor (VEGF) humanized antibody medicine JY028 and anti-tumor necrosis factor-α (TNF-α) all-human antibody medicine JY026, have been approved by china food and drug administration (CFDA) for clinical trials within half a month. It can be described as double happiness! At present, JY09, JY028 and JY026 have entered clinical research.

 

 

JY026 Basic Overview

1. Bioanalogs

JY026 is an anti TNF- α The whole human antibody drug is a biological analogue of adalimumab.

2. Main action mechanism

It is an all human IgG1 type monoclonal antibody α (TNF- α) Specific binding to prevent TNF- α Activates TNF receptors on the surface of p55 and p75 cells.

JY026 Main Action Mechanism Diagram

 

3. Indications

The approved clinical indications of the drug are: rheumatoid arthritis, ankylosing spondylitis and other autoimmune diseases.

Rheumatoid arthritis (RA) is a chronic disabling autoimmune disease characterized by symmetry, multiple joints and small joints. It is known as "cancer that cannot die". The patient's immune system will damage healthy joints, which can cause joint pain, swelling, stiffness, fatigue and weakness symptoms in the early stage, and reduce the quality of life. If the disease is not controlled in time, it is easy to lead to disability and loss of labor ability. It brings great pain to patients and their families. It also brings great economic losses to the society.

 

Rheumatoid arthritis

 

Ankylosing spondylitis is a chronic disease with the spine as the main lesion. Sacroiliac joint is involved, causing spinal rigidity and fibrosis. It causes varying degrees of eye, lung, muscle and bone lesions, which is an autoimmune disease. The morbidity of ankylosing spondylitis is high. According to the survey, patients with ankylosing spondylitis will eventually lead to varying degrees of disability. Therefore, it will affect the working ability and self-care ability and increase the financial burden of the patient's family.

 

Ankylosing spondylitis

 

JY026 The original drug "King of Medicine" Adalimumab

1. Development background and market of original drugs

Adalimumab was developed by Abbvie under the trade name Humira ®, Xiumeile ®。

It was approved by the US Food and Drug Administration (FDA) in December 2002.

It was approved by the European Medicines Agency (EMA) in September 2003.

In April 2008, it was approved by Japan Pharmaceutical and Medical Device Agency (PMDA).

In February 2010, it was approved for listing by China Food and Drug Administration (CFDA).

Adalimumab is the world's best-selling prescription drug. Since winning the title of the global "drug king" in 2012, the 
runaway wild horse has repeatedly created sales miracles that are beyond our reach. In 2015, its annual sales reached $14 
billion. In 2016, the sales volume was once again striking, reaching 16 billion US dollars, equivalent to more than 100 
billion yuan. It once again defended its crown.

2. Numerous indications

The globally approved indications of the drug are rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease in adults, Crohn's disease in children, ulcerative colitis, plaque psoriasis, purulent sweat gland inflammation and non infectious uveitis.

After entering the Chinese market, it has 2 indications. In August 2010, it was approved for the treatment of moderate and severe rheumatoid arthritis. In July 2013, it was approved for the treatment of ankylosing spondylitis.

 

Challenges and opportunities coexist

The US patent for Humira expired in December 2016. The European patent expires in April 2018. The Chinese patent expired in February 2017. Because of the patent cliff approaching and high added value, Adalimumab has become a variety that domestic and foreign companies compete to copy. At present, many biosimilar drug developers have already rubbed their hands, including Amgen, Merck, Samsung Bioepis, Novartis, Baxter, Momenta and other well-known pharmaceutical giants. At the same time, there has been a boom in the development of biological analogues in China.

In recent years, the incidence rate of autoimmune diseases and other major diseases in China has increased year by year. There is a huge clinical demand for such monoclonal antibody drugs in China. The domestic market scale of monoclonal antibody is still small. There are few enterprises with mature antibody industrial system and large-scale production capacity. Stimulated by the favorable situation that a number of foreign McAbs have passed the patent protection period and domestic McAbs have successively entered the local medical insurance, McAbs biological analogues face a broad market space.

 

 

The successful approval of clinical applications such as JY026 has greatly promoted Dongfang Baitai to quickly enter the field of monoclonal antibody drugs with huge market potential in the future.

The smooth implementation of the clinical trial will solve the problem that the monoclonal antibody products in the treatment of autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis in China are completely dependent on imports. In turn, it will provide China's patients with market accessible, reliable quality and reasonable price of monoclonal antibody drugs. It fills the huge gap of clinical medication for patients and reduces the economic burden of patients. It brings a new dawn for the treatment of patients with autoimmune 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.

 

Dongfang Baitai

Beijing Dongfang Baitai Biotechnology Co., Ltd. is located in Yizhuang Park, Zhongguancun. The company covers an area of nearly 60000 square meters. Is an innovative antibody research and development and production of high-tech enterprises. It mainly focuses on new products of major disease treatment and preventive biological medicine.

 

Dongfang Baitai monoclonal antibody platform

 

The company has an international professional antibody research and development team of hundreds of people. It has built an industrial technology platform with world advanced level and integrated research and production, focusing on original antibody drugs and new vaccines. Nearly 20 R&D pipelines have been deployed in tumor, diabetes and autoimmune diseases. It will 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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