Changchun High & New Technology Industries (Group) Inc., a Chinese corporation listed on the Shenzhen Stock Exchange (SHE: 000661), has received tacit approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its Category 1 biologic product, GenSci098. This humanized anti-TSHR antagonistic monoclonal antibody (mAb) is intended for the treatment of thyroid eye disease (TED), an indication for which it has already gained clinical approval in China earlier this month.
GenSci098 is designed to specifically bind to the thyroid stimulating hormone receptor (TSHR), thereby blocking the binding of autoantibodies that trigger the release of inflammatory factors and the synthesis of hyaluronic acid (HA). Preclinical research indicates that GenSci098 may offer a groundbreaking therapeutic strategy for managing TED.
Thyroid eye disease (TED) is an orbital inflammatory condition associated with thyroid disorders, stemming from autoimmune system dysfunction. This condition impacts patients’ facial appearance, diminishes their quality of life, and can cause significant psychological strain. In extreme cases, TED can lead to blindness.- Flcube.com
