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Not long ago, Huadong Medicine announced that its subsidiary Sino-US Huadong and AKSO Biopharmaceutical of the United States will "join hands" and will acquire the latter's global innovative drug AB002 (for the treatment of solid tumors) in the Asia-Pacific region (except Japan) for no more than US$75 million.
) exclusive clinical development and commercialization rights, which is also an important cooperation for the company to deepen the global innovation and R&D track layout
.
In recent days, the pharmaceutical company has accelerated its deployment in the field of autoimmunity
.
On February 22, 2022, Sino-US Huadong, a wholly-owned subsidiary of Huadong Medicine, signed a product license agreement with Kiniksa, a wholly-owned subsidiary of US listed company Kiniksa Pharmaceuticals,
Ltd.
According to the agreement, Sino-US Huadong will obtain the licenses of Kiniksa's two global innovative products in the field of autoimmunity, Arcalyst and Mavrilimumab, in 24 Asia-Pacific countries and regions (excluding Japan), including China, South Korea, Australia, New Zealand and India, including development, registration and commercialization rights
.
At the same time, Central America East will pay Kiniksa an upfront payment of $22 million, development, registration and sales milestone payments of up to $640 million, as well as tiered double-digit royalties on net sales
.
The announcement shows that Arcalyst (Rilonacept) was developed by Regeneron.
In 2017, Kiniksa obtained a license from Regeneron for Rilonacept to be developed for the treatment of recurrent pericarditis indications
.
The product received FDA breakthrough therapy designation in 2019 and FDA orphan drug designation in 2020
.
In 2020, the European Commission granted Rilonacept Orphan Drug Designation for the treatment of idiopathic pericarditis
.
In March 2021, Rilonacept received FDA approval for the treatment of recurrent pericarditis
.
In addition, the indication of this product for the treatment of cold pyridine-related periodic syndrome has been included in the list of overseas new drugs urgently needed in China in 2018, but the domestic registration application has not yet been carried out, and it has not yet been approved for marketing in China
.
According to the data disclosed by Kiniksa, the sales of this product in 2021 will show a quarterly growth trend.
From the second quarter to the fourth quarter, the net income will be $7.
7 million, $12.
1 million, and $18.
7 million, respectively
.
Mavrilimumab is a fully human monoclonal antibody that targets granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSFRα) and inhibits the expression of granulocyte-macrophage colony-stimulating factor (GM-CSF).
signaling
.
Kiniksa obtained a global license for Mavrilimumab from MedImmune Limited in 2017
.
Kiniksa is preparing to launch an overseas Phase II clinical trial of Mavrilimumab for GM-CSF-related cardiovascular disease
.
The company will plan to start the registration and declaration of licensed products in China based on the progress of research and development
.
Autoimmunity has become one of the most widely concerned disease areas in the world besides tumors, and its market share is gradually expanding
.
According to Frost & Sullivan's forecast, the global autoimmune disease drug market will reach US$163.
8 billion by 2030, of which China's market size is expected to reach US$24.
1 billion by 2030
.
But at present, there are relatively few pharmaceutical companies developing drugs for rare diseases, and patients with rare diseases are in urgent need of related therapeutic drugs.
As Huadong Medicine accelerates the introduction of innovative First-in-Class biological drugs, it will accelerate the satisfaction of autoimmune and rare diseases patients' clinical needs
.
Huadong Medicine said that in addition to the existing indications, Kiniksa's two autoimmune products also have the potential to develop other potential autoimmune indications.
The strong synergistic effect helps to better integrate resources, release the company's R&D and technological advantages, and enhance the company's core competitiveness in the field of immunization
.
According to the data, Huadong Medicine is a company with global innovative drug layout in the three core therapeutic areas of anti-tumor, endocrine and autoimmunity. .
Among them, in the field of autoimmunity, the company has ten immune products through the driving model of independent research and development and external cooperation, forming a rich and differentiated pipeline layout, product indications cover dermatology, rheumatology, cardiovascular, respiratory, renal Internal Medicine, Transplant Surgery,
etc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
) exclusive clinical development and commercialization rights, which is also an important cooperation for the company to deepen the global innovation and R&D track layout
.
In recent days, the pharmaceutical company has accelerated its deployment in the field of autoimmunity
.
On February 22, 2022, Sino-US Huadong, a wholly-owned subsidiary of Huadong Medicine, signed a product license agreement with Kiniksa, a wholly-owned subsidiary of US listed company Kiniksa Pharmaceuticals,
Ltd.
According to the agreement, Sino-US Huadong will obtain the licenses of Kiniksa's two global innovative products in the field of autoimmunity, Arcalyst and Mavrilimumab, in 24 Asia-Pacific countries and regions (excluding Japan), including China, South Korea, Australia, New Zealand and India, including development, registration and commercialization rights
.
At the same time, Central America East will pay Kiniksa an upfront payment of $22 million, development, registration and sales milestone payments of up to $640 million, as well as tiered double-digit royalties on net sales
.
The announcement shows that Arcalyst (Rilonacept) was developed by Regeneron.
In 2017, Kiniksa obtained a license from Regeneron for Rilonacept to be developed for the treatment of recurrent pericarditis indications
.
The product received FDA breakthrough therapy designation in 2019 and FDA orphan drug designation in 2020
.
In 2020, the European Commission granted Rilonacept Orphan Drug Designation for the treatment of idiopathic pericarditis
.
In March 2021, Rilonacept received FDA approval for the treatment of recurrent pericarditis
.
In addition, the indication of this product for the treatment of cold pyridine-related periodic syndrome has been included in the list of overseas new drugs urgently needed in China in 2018, but the domestic registration application has not yet been carried out, and it has not yet been approved for marketing in China
.
According to the data disclosed by Kiniksa, the sales of this product in 2021 will show a quarterly growth trend.
From the second quarter to the fourth quarter, the net income will be $7.
7 million, $12.
1 million, and $18.
7 million, respectively
.
Mavrilimumab is a fully human monoclonal antibody that targets granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSFRα) and inhibits the expression of granulocyte-macrophage colony-stimulating factor (GM-CSF).
signaling
.
Kiniksa obtained a global license for Mavrilimumab from MedImmune Limited in 2017
.
Kiniksa is preparing to launch an overseas Phase II clinical trial of Mavrilimumab for GM-CSF-related cardiovascular disease
.
The company will plan to start the registration and declaration of licensed products in China based on the progress of research and development
.
Autoimmunity has become one of the most widely concerned disease areas in the world besides tumors, and its market share is gradually expanding
.
According to Frost & Sullivan's forecast, the global autoimmune disease drug market will reach US$163.
8 billion by 2030, of which China's market size is expected to reach US$24.
1 billion by 2030
.
But at present, there are relatively few pharmaceutical companies developing drugs for rare diseases, and patients with rare diseases are in urgent need of related therapeutic drugs.
As Huadong Medicine accelerates the introduction of innovative First-in-Class biological drugs, it will accelerate the satisfaction of autoimmune and rare diseases patients' clinical needs
.
Huadong Medicine said that in addition to the existing indications, Kiniksa's two autoimmune products also have the potential to develop other potential autoimmune indications.
The strong synergistic effect helps to better integrate resources, release the company's R&D and technological advantages, and enhance the company's core competitiveness in the field of immunization
.
According to the data, Huadong Medicine is a company with global innovative drug layout in the three core therapeutic areas of anti-tumor, endocrine and autoimmunity. .
Among them, in the field of autoimmunity, the company has ten immune products through the driving model of independent research and development and external cooperation, forming a rich and differentiated pipeline layout, product indications cover dermatology, rheumatology, cardiovascular, respiratory, renal Internal Medicine, Transplant Surgery,
etc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
