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On November 15, 2021, Zai Lab announced that Efgartigimod will be used for the treatment of patients with pemphigus vulgaris (PV) or deciduous pemphigus (PF).
The global registration phase 3 ADDRESS study has completed the first patient in Greater China.
Administration
.
The ADDRESS study is a randomized, double-blind, placebo-controlled, multicenter clinical study designed to evaluate the safety and effectiveness of Efgartigimod in approximately 150 patients with pemphigus vulgaris or pemphigus foliaceus
.
The enrolled patients will include those newly diagnosed or relapsed patients who meet the requirements of the protocol
.
On the basis of prednisone treatment, patients will be randomly assigned to Efgartigimod subcutaneous injection preparation group or placebo group at 2:1
.
Pemphigus vulgaris and deciduous pemphigus are rare and serious autoimmune diseases.
Inside the human body, antibodies attack the skin surface proteins and cause blisters on the skin
.
Pemphigus vulgaris is the most common type of pemphigus
.
In pemphigus vulgaris, the immune system produces IgG antibodies that mistakenly attack the desmosomal glycoprotein and desmosomal glycoprotein that connect skin and mucosal cells, resulting in separation of skin and mucosal cells, and tissue fluid in the skin and mucosal layers.
Gather between them, forming blisters and ulcers
.
These lesions can cause severe pain, itching, and burning
.
In severe cases, severe skin peeling occurs with life-threatening fluid loss and a great risk of infection
.
For deciduous pemphigus, the antibody only attacks desmosomal glycoproteins that are only expressed in the skin
.
Therefore, blisters may appear on the scalp, face or trunk, but it does not affect the mucous membranes, so deciduous pemphigus does not affect the mouth or eyes
.
Efgartigimod is an antibody fragment under development, designed to reduce pathogenic immunoglobulin G (IgG) antibodies and block IgG circulation
.
Efgartigimod can bind to FcRn, which is widely expressed throughout the body and plays a central role in preventing the degradation of IgG antibodies
.
Blocking FcRn can reduce the expression level of IgG antibodies, and can treat autoimmune diseases known to be driven by pathogenic IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris ( PV), a chronic skin disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic disease manifested by ecchymosis and bleeding; chronic inflammatory demyelinating polyneuropathy (CIDP) ), a disease in which damage to the nervous system causes movement disorders
.
The previous phase 2 clinical study showed that efgartigimod is well tolerated and can quickly affect disease activity in the early treatment period, confirming that it can reduce IgG and anti-desmosome autoantibodies and improve the pemphigus disease area index
.
On January 6, 2021, Zai Lab announced the introduction of the product from argenx.
Zai Lab will be responsible for advancing the development and commercialization of Efgartigimod in Greater China (including Mainland China, Hong Kong, Taiwan and Macau)
.
argenx will receive a total of 175 million US dollars in cooperative payments, including an upfront payment of 75 million US dollars, 568,182 additional Zai Lab shares issued at a price of 132 US dollars per share, and 75 million US dollars in clinical development cost sharing payments, and Efgartigimod's $25 million milestone payment after approval in the United States
.
argenx will also receive a proportional share of Efgartigimod's annual net sales in Greater China
.
It is estimated that there are approximately 90,000 pemphigus patients in China
.
The current treatment options are limited, mainly corticosteroids and immunosuppressants
.
If the symptoms cannot be controlled, they will be combined with other therapies such as intravenous immunoglobulin or rituximab, steroid drugs and immunosuppressive agents
.
Despite the available treatment options, the remission/relapse cycle of the disease is still very common, and there are still safety issues with long-term use of existing drugs
.
There is still a huge unmet need for innovative treatment options that provide early disease control and safe long-term response
.
Looking forward to the follow-up clinical performance of Zai Lab's new drug
.
Source: Zai Lab's official website disclaimer The articles reproduced on the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
The global registration phase 3 ADDRESS study has completed the first patient in Greater China.
Administration
.
The ADDRESS study is a randomized, double-blind, placebo-controlled, multicenter clinical study designed to evaluate the safety and effectiveness of Efgartigimod in approximately 150 patients with pemphigus vulgaris or pemphigus foliaceus
.
The enrolled patients will include those newly diagnosed or relapsed patients who meet the requirements of the protocol
.
On the basis of prednisone treatment, patients will be randomly assigned to Efgartigimod subcutaneous injection preparation group or placebo group at 2:1
.
Pemphigus vulgaris and deciduous pemphigus are rare and serious autoimmune diseases.
Inside the human body, antibodies attack the skin surface proteins and cause blisters on the skin
.
Pemphigus vulgaris is the most common type of pemphigus
.
In pemphigus vulgaris, the immune system produces IgG antibodies that mistakenly attack the desmosomal glycoprotein and desmosomal glycoprotein that connect skin and mucosal cells, resulting in separation of skin and mucosal cells, and tissue fluid in the skin and mucosal layers.
Gather between them, forming blisters and ulcers
.
These lesions can cause severe pain, itching, and burning
.
In severe cases, severe skin peeling occurs with life-threatening fluid loss and a great risk of infection
.
For deciduous pemphigus, the antibody only attacks desmosomal glycoproteins that are only expressed in the skin
.
Therefore, blisters may appear on the scalp, face or trunk, but it does not affect the mucous membranes, so deciduous pemphigus does not affect the mouth or eyes
.
Efgartigimod is an antibody fragment under development, designed to reduce pathogenic immunoglobulin G (IgG) antibodies and block IgG circulation
.
Efgartigimod can bind to FcRn, which is widely expressed throughout the body and plays a central role in preventing the degradation of IgG antibodies
.
Blocking FcRn can reduce the expression level of IgG antibodies, and can treat autoimmune diseases known to be driven by pathogenic IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris ( PV), a chronic skin disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic disease manifested by ecchymosis and bleeding; chronic inflammatory demyelinating polyneuropathy (CIDP) ), a disease in which damage to the nervous system causes movement disorders
.
The previous phase 2 clinical study showed that efgartigimod is well tolerated and can quickly affect disease activity in the early treatment period, confirming that it can reduce IgG and anti-desmosome autoantibodies and improve the pemphigus disease area index
.
On January 6, 2021, Zai Lab announced the introduction of the product from argenx.
Zai Lab will be responsible for advancing the development and commercialization of Efgartigimod in Greater China (including Mainland China, Hong Kong, Taiwan and Macau)
.
argenx will receive a total of 175 million US dollars in cooperative payments, including an upfront payment of 75 million US dollars, 568,182 additional Zai Lab shares issued at a price of 132 US dollars per share, and 75 million US dollars in clinical development cost sharing payments, and Efgartigimod's $25 million milestone payment after approval in the United States
.
argenx will also receive a proportional share of Efgartigimod's annual net sales in Greater China
.
It is estimated that there are approximately 90,000 pemphigus patients in China
.
The current treatment options are limited, mainly corticosteroids and immunosuppressants
.
If the symptoms cannot be controlled, they will be combined with other therapies such as intravenous immunoglobulin or rituximab, steroid drugs and immunosuppressive agents
.
Despite the available treatment options, the remission/relapse cycle of the disease is still very common, and there are still safety issues with long-term use of existing drugs
.
There is still a huge unmet need for innovative treatment options that provide early disease control and safe long-term response
.
Looking forward to the follow-up clinical performance of Zai Lab's new drug
.
Source: Zai Lab's official website disclaimer The articles reproduced on the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
