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| The State Food and Drug Administration approves the world's first light chain amyloidosis treatment drug to be marketed |
Primary light chain amyloidosis is a rare and fatal blood disease.
The plasma cells in the patient’s bone marrow will produce abnormal amyloid light chains and continue to deposit in vital organs, eventually leading to organ failure or even death
.
Primary light chain amyloidosis usually has no typical symptoms and is easily confused with other diseases
Professor Zhang Yun, an academician of theChinese Academy of Engineering and a well-known cardiologist, pointed out: “Primary light chain amyloidosis can damage various organs of patients.
If vital organs such as the heart or kidneys are involved, the patient’s survival time will be greatly shortened
.
Usually , the patient’s survival time will be shortened .
academician
On October 11, the National Medical Products Administration formally approved the innovative drug Zhaokesu (Daletuzumab) from Xi’an Janssen, a subsidiary of Johnson & Johnson in China, to be used in combination with bortezomib, cyclophosphamide and dexamethasone.
It is used to treat patients with newly diagnosed primary light chain amyloidosis, but this regimen is not suitable or recommended for patients with NYHA IIIB or IV heart disease (New York Society of Cardiology Heart Function Classification), or Mayo IIIB (Mayo staging) patients with primary light chain amyloidosis
.
Zhaokesu is the world's first and currently the only innovative solution approved for the treatment of patients with systemic light chain amyloidosis
.
Clinical studies have shown that the combined treatment plan based on Zhaokesu can help patients achieve rapid and deep hematological relief and organ relief
Professor Huang Xiaojun, Director of the Institute of Hematology, Peking University, shared that: “The main treatment goal of primary light chain amyloidosis is to help patients achieve organ remission and prolong life through deep and long-lasting hematological remission.
Rice-based innovative treatments for multiple myeloma, etc.
, can bring some relief to patients with primary light chain amyloidosis, but the clinic still faces severe treatment challenges, and more effective treatment methods are urgently needed.
The approval of Zhaokesu undoubtedly allows us to help patients achieve blood and organ relief in a more convenient and safer way
.
"
The approval of Zhao Kesu is based on a global phase III clinical study ANDROMEDA, which evaluated daretuzumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd), compared with boron The efficacy of tezomib, cyclophosphamide and dexamethasone (VCD) in the treatment of newly diagnosed patients with primary light chain amyloidosis
.
The results of the study showed that daretuzumab combined with bortezomib, cyclophosphamide and dexamethasone, compared with bortezomib, cyclophosphamide and dexamethasone alone, achieved a hematological complete remission rate of about 3 times.
