By Fineline Cube 
China‑based RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) on Aug, 27, 2025announced that its first‑in‑class BLyS/APRIL dual‑target fusion protein, Telitacicept, achieved its primary endpoint in the A‑stage of a Phase III clinical trial conducted in China for primary IgA nephropathy.
Key Clinical Findings
- 24‑hour UPCR Reduction – Telitacicept reduced the urinary protein‑creatinine ratio by 55 % versus placebo at week 39 (P < 0.0001).
- Safety Profile – The drug demonstrated a favorable tolerability and safety profile, with no new safety signals reported.
Regulatory Pathway
RemeGen will submit a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) “as soon as possible,” positioning the company for a potential market entry in China’s growing nephrology segment.
Scientific Rationale
Telitacicept uniquely blocks both B‑lymphocyte stimulator (BLyS) and proliferation‑inducing ligand (APRIL)—cytokines that are markedly elevated in IgA nephropathy and drive B‑cell hyperactivity, plasma‑cell expansion, and pathogenic immunoglobulin production. By dampening these pathways, the drug mitigates immune‑complex deposition and the ensuing renal inflammation, a mechanism not addressed by any other approved therapy in China.-Fineline Info & Tech