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Text|Pharmaceutical Mission Hills
On August 9, the Chinese drug clinical trial registration and information disclosure platform showed that the efgartigimod injection introduced by Zai Lab for US$175 million has initiated a phase 3, Multi-center, open, long-term research
.
This is a potential "first-in-class" therapy targeting FcRn.
Screenshot source: Chinadrugtrials
Efgartigimod is a research antibody fragment targeting FcRn developed by argenx, which aims to reduce pathogenic immunoglobulin G (IgG) antibodies and block IgG circulation
.
FcRn is widely expressed throughout the body and plays a central role in preventing the degradation of IgG antibodies
In January 2021, Zai Lab issued a press release stating that it will obtain the exclusive right to develop and commercialize argenx's new drug efgartigimod in Greater China for a total of US$175 million in cooperative payments
.
The launch in China this time is a phase 3, multi-center, open, long-term study evaluating the safety and effectiveness of efgartigimod (ARGX-113) PH20 subcutaneously administered in adult patients with ITP
.
The primary endpoint indicators of the study are safety indicators, including: 1) the incidence, frequency and severity of adverse events (AE), adverse events of special concern (AESI) and serious adverse events (SAE); 2) vital signs, electrocardiogram ( ECG) and laboratory safety evaluation
Immune thrombocytopenia is a rare and serious autoimmune disease
.
In ITP patients, the immune system attacks and destroys the body's own platelets, which play an active role in blood clotting and wound healing
For these patients, although there is no cure, thrombopoietin receptor agonists (TPO-RA) are often used to effectively manage the disease
.
However, factors such as weekly subcutaneous administration, potential liver toxicity and food restriction may become important obstacles to effective treatment of TPO-RA
I hope that efgartigimod's clinical research in China will progress smoothly and be approved for marketing as soon as possible, bringing new treatment options to more patients with primary immune thrombocytopenia
Reference materials:
[1] China Drug Clinical Trial Registration and Information Disclosure Platform.
