Excyte begins clinical trial for new therapy targeting kidney disease

HONG KONG, May 29, 2025 – Excyte, a global clinical-stage biotechnology company, announced today that the first patient has been dosed in a trial for YK012, a T-cell engaging therapy for primary membranous nephropathy (pMN). This is the first clinical trial for a therapy of its kind for this autoimmune disease.

pMN is an autoimmune condition where antibodies attack the kidney's podocytes, leading to the formation of immune complexes. It is the most common cause of primary nephrotic syndrome in adults worldwide. Current treatments, such as rituximab and cyclophosphamide, are ineffective for 20-30% of patients, and relapse rates are high.

The YK012 study aims to evaluate the therapy's safety, tolerability, and preliminary efficacy in pMN patients. The trial will be conducted across multiple centers in China, led by Professor Minghui Zhao and Professor Zhao Cui from Peking University First Hospital. Excyte and its international partners will conduct a parallel clinical study in the United States.

The company previously received approval for YK012's clinical use from China's National Medical Products Administration. Excyte has also secured approval for other autoimmune conditions, including systemic lupus erythematosus, and is preparing to file for an Investigational New Drug (IND) application in the U.S.

YK012 is a bispecific antibody targeting CD19 and CD3 molecules. It activates T-cells via the CD3 target and engages B-cells via the CD19 target, leading to B-cell depletion. According to the company, previous studies have demonstrated a prolonged half-life and limited cytokine release.

Excyte is developing YK012 for both autoimmune diseases and oncological indications, including NHL and ALL. The company operates with a dual hub in China and the U.S. and focuses on developing novel bispecific antibody drugs.