Changchun Hi-Tech (000661.SZ): Clinical trial application for registration of domestically produced GenSci 136 drugs for injection 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 domestically produced drug registration application for injectable GenSci136 was accepted.

GenSci136 uses a novel molecular structure and BAFF/April dual-target action mechanism. Its main body is B-cellmaturation antigen (BCMA) trimer fusion protein, which simulates the binding of natural receptors with B-lymphocyte stimulating factors (Blymphocytestators, BLYs, also known as BAFF) and proliferation-inducing ligand (APRIL) through trimer design to enhance the blocking activity of BAFF and APRIL signaling pathways; at the same time, antibodies are introduced Serum albumin monodomain antibody (anti-HSAVHH) to prolong the half-life of the drug in the body. BAFF and APRIL are important cytokines that regulate B-cell survival, maturation, differentiation, and antibody secretion, and play an important role in the occurrence and development of autoimmune diseases such as SLE. By simultaneously blocking BAFF and April signals, GenSci136 is expected to more comprehensively inhibit the survival and function of abnormal B cells and antibody-secreting cells, thereby improving tissue and organ damage mediated by abnormal humoral immunity and pathogenic autoantibodies.

Results of non-clinical pharmacodynamics, pharmacokinetics and toxicology studies show that GenScI136 has good pharmacological activity, long-lasting exposure characteristics, and acceptable safety characteristics, and is expected to provide new treatment options for Chinese SLE patients.

Previously, clinical trial applications for injectable GenSci 136 to treat systemic myasthenia gravis (GMG), immunoglobulin A nephropathy (IgAN), and ocular myasthenia gravis (OMg) were approved by the National Drug Administration; clinical trial applications for myasthenia gravis (MG) indications were approved by the US Food and Drug Administration.