Changchun High-Tech Industry (000661.SZ) subsidiary's GenSci161 Injection domestic production drug registration clinical trial application accepted

Changchun High-Tech Industry (000661.SZ) announced that recently, its controlling subsidiary, Changchun GeneScience Pharmaceutical Co., Ltd. (hereinafter referred to as "GeneScience Pharmaceuticals"), received a Notice of Acceptance issued by the National Medical Products Administration, and the domestic production drug registration clinical trial application for GeneScience Pharmaceuticals' GenSci161 Injection has been accepted. GenSci161 Injection is a Class 1 therapeutic biological product independently developed by GeneScience Pharmaceuticals. It is a novel fully human monoclonal IgG1 bispecific antibody, intended for the treatment of recurrent pericarditis (RP). GenSci161 Injection can simultaneously target two subtypes in RP (IL-1 and IL-1), inhibiting the IL-1-mediated inflammatory initiation and amplification process, thereby reducing disease inflammatory activity and recurrence risk, and is expected to provide a new treatment option for RP patients. Previously, the domestic production drug registration clinical trial applications for GenSci161 Injection for the treatment of endometriosis (EM), moderate-to-severe hidradenitis suppurativa, and non-infectious uveitis (NIU) have all been approved by the National Medical Products Administration; the overseas production drug trial application for hidradenitis suppurativa (HS) has been approved by the FDA; and the domestic production drug registration clinical trial application for connective tissue disease-associated interstitial lung disease (CTD-ILD) has been accepted by the National Medical Products Administration.