Changchun Genescience Pharmaceutical received NMPA clearance to begin clinical trials of Gensci‑136, a dual APRIL/BAFF antagonist formulated for injection to treat immunoglobulin A nephropathy (IgAN). The NMPA clearance permits first‑in‑human evaluation in China and positions Gensci‑136 among emerging therapeutic approaches targeting B‑cell survival factors in IgAN. The dual APRIL/BAFF mechanism aims to reduce pathogenic IgA production by modulating plasma cell and B‑cell pathways implicated in glomerular IgA deposition. The regulatory greenlight follows preclinical work supporting the candidate’s pharmacology and safety profile. Why it matters: new targeted biologics in IgAN could shift treatment paradigms away from broad immunosuppression toward pathway-specific strategies and create partnership or licensing opportunities for companies developing complementary assets.
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