On August 15th, Gelonhui announced that Staidson (300204.SZ) received the drug clinical trial approval notice (Notice No. 2024LP01413) for STSP-0902 injection for the treatment of oligoasthenospermia (OA) from the National Medical Products Administration in June 2024, and agreed to conduct clinical trials of STSP-0902 injection for OA. Recently, the first subject of Ia-stage clinical trial for OA has been dosed with STSP-0902 injection in the Third Hospital of Peking University.
STSP-0902 is a recombinant human nerve growth factor Fc-fusion protein developed by Staidson through targeted modification of specific sites, which can bind and activate the TrkA receptor pathway and exert biological effects. Preclinical experimental data shows that STSP-0902 can promote neurogenesis, proliferation of spermatogonial cells and testicular support cells, increase sperm count and vitality in a mouse model of OA, reduce sperm abnormality rate, and improve seminiferous tubule degeneration/atrophy. Meanwhile, compared with wild-type human nerve growth factor, STSP-0902 exhibits features of reduced pain reaction after injection and prolonged half-life in preclinical research.
