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 the registration clinical trial application for domestically produced drugs of Jinsai Pharmaceutical GenSci 161 injection was accepted.
GenScI 161 injection is a therapeutic biological product class 1 drug independently developed by Jinsai Pharmaceutical. It is a novel all-human monoclonal IgG1 bispecific antibody and is intended for the treatment of recurrent pericarditis (RP).
GenSci161 injection can simultaneously target two subtypes of RP (IL-1α and IL-1β) to inhibit IL-1-mediated inflammatory initiation and amplification processes, thereby reducing inflammatory activity and risk of recurrence of the disease, and is expected to provide new treatment options for RP patients.
Previously, clinical trial applications for domestically produced drugs using GenSci161 injection to treat endometriosis (EM), moderate to severe suppurative hydradenitis, and non-infectious uveitis (NIU) had all been approved by the National Drug Administration; test applications for drugs produced abroad for suppurative hidradenitis (HS) had been approved by the FDA; the registration of domestically produced clinical trial applications for connective tissue disease-related interstitial lung disease (CTD-ILD) had been accepted by the National Drug Administration.