Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its modified drug HR19042, which targets active autoimmune hepatitis (AIH).
AIH is a rare liver disease that, if untreated, can rapidly progress to cirrhosis or end-stage liver disease. Current treatment options for AIH patients involve long-term immunosuppressive therapy, which can be limited by adverse reactions associated with glucocorticoids. The development of new drugs for AIH is of significant clinical importance, as it could reduce the risk of glucocorticoid-related adverse reactions by decreasing systemic exposure to these drugs.
HR19042, an oral capsule, is designed to enhance the stability of endothelial and smooth muscle cells, as well as the lysosomal membrane. It works by inhibiting immune responses and reducing antibody synthesis, thereby decreasing the release and activity of allergic active mediators such as histamine. This novel approach could revolutionize AIH treatment by mitigating the need for long-term immunosuppressive therapy. Notably, there is no similar product approved worldwide, highlighting the potential impact of HR19042 on the global landscape of AIH treatment.- Flcube.com
