Changchun Hi-Tech (000661.SZ): Jinsai Pharmaceutical's application for registration of domestically produced drug registration for GenSci 117 inhalation powder was accepted

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 “Notice of Acceptance” approved and issued by the State Drug Administration, and Jinsai Pharmaceutical's application for registration of domestically produced drugs for GenSci117 inhalation powder was accepted. GenSci117 powder for inhalation (hereinafter referred to as GenSci117) is an innovative drug independently developed by Jinsai Pharmaceutical. It is registered as a Class 1 chemical and is intended to be used to treat idiopathic pulmonary fibrosis (IPF).

GenScI117 is a novel small interfering RNA (siRNA) drug targeting the matrix metalloproteinase 7 (MMP7) for inhalation. Its design is based on the company's extra-hepatic siRNA delivery platform gPODS™. It has high sequence specificity and subtype selectivity, and is a novel intervention route to accurately target specific subtypes. MMP7 is mainly secreted by epithelial-derived cells and activated macrophages; in pathological conditions, it is involved in fibrosis, tumor invasion, and inflammation. GenSci117 is a double-stranded siRNA drug. Small molecule ligands mediate targeted delivery of siRNA to target cells, then siRNA specifically identifies and promotes MMP7 mRNA degradation through the RNA interference (RNAi) mechanism, thereby inhibiting MMP7 expression at post-transcriptional levels, reducing the production and accumulation of MMP7 protein, and ultimately weakening its pro-fibrosis effect. GenSci 117 uses inhalation administration to accurately deliver the drug to the lesion site of the lung to achieve high local exposure and reduce systemic exposure; at the same time, this product is expected to achieve a dosing cycle every 2 months, which can significantly improve the convenience of administration, thereby improving patient compliance. Preclinical research data shows that this product has significant differentiating advantages and is expected to provide patients with new treatment options.