Zhitong Finance App News, Changchun Hi-Tech (000661.SZ) issued an announcement. Recently, the company's holding subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”) received the “Drug Clinical Trial Approval Notice” approved and issued by the State Drug Administration, and Jinsai Pharmaceutical's application for registration of drugs produced domestically produced in GenSci161 injection was approved. GenScI 161 injection is a therapeutic biological product class 1 drug independently developed by Jinsai Pharmaceutical. It has now been approved to conduct clinical trials for connective tissue disease-related interstitial lung disease (CTD-ILD) indications.
GenSci161 injection is a novel all-human monoclonal IgG1 bispecific antibody that simultaneously targets two subtypes (IL-1α and IL-1β) of the key pro-inflammatory cytokine interleukin-1 (IL-1), thereby blocking IL-1 mediated inflammatory signaling pathway activation, inhibiting the production and release of various downstream pro-inflammatory cytokines, and achieving more comprehensive regulation of inflammation. Recent studies have shown that inflammatory factors play an important role in the occurrence and development of CTD-ILD. Among them, interleukin-1 (IL-1) can activate various inflammatory signaling pathways, promote immune cell recruitment, induce fibroblast activation, and promote collagen deposition, thereby playing an important role in the inflammation-fibrosis transformation process. Treatment strategies targeting IL-1 may provide a new intervention route for CTD-ILD. GenSci161 injections have potential clinical value in treating CTD-ILD and are expected to provide new treatment options.