Excyte begins clinical testing of novel pMN therapy in China

CHINA— Excyte, a global clinical-stage biotechnology company, has announced a significant milestone with the dosing of the first patient in a clinical trial for YK012, the world’s first T cell engager (TCE) therapy designed specifically for primary membranous nephropathy (pMN).

The patient tolerated the treatment well, with no adverse reactions reported so far.

Primary membranous nephropathy is an autoimmune disease characterized by the immune system attacking podocyte antigens in the kidneys, leading to the formation of immune complexes that damage kidney function.

It is the most common cause of primary nephrotic syndrome in non-diabetic adults worldwide, affecting between 20% and 37% of such patients, and up to 40% of adults over 60 years old.

Despite existing treatments like rituximab and cyclophosphamide, 20-30% of pMN cases are resistant, and relapse rates remain high, highlighting a significant unmet medical need.

The ongoing clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of YK012 in pMN patients.

It is a multi-center study in China led by Professor Minghui Zhao and Professor Zhao Cui from Peking University First Hospital.

Excyte plans to file for a U.S. Investigational New Drug (IND) application soon, with the U.S. trial to be conducted in collaboration with international partners.

This regulatory pathway in the U.S. could potentially position YK012 as one of the first approved TCE therapies for autoimmune diseases, paving the way for further indications in autoimmune and oncology fields.

YK012 is a bispecific antibody that targets both CD19 and CD3. It activates T-cell immunity through CD3 while targeting CD19, a key marker expressed during B-cell development, effectively enabling a “B-cell reset.”

 According to Andrew Meng, Excyte’s chairman and COO, clinical data so far demonstrate that YK012 induces significant B cell depletion with an extended half-life and limited cytokine release, which suggests a favourable safety profile.

 The therapy also shows milder T cell activation compared to existing treatments like Blincyto, reducing the risk of excessive immune responses.

In December 2024, YK012 received clinical trial approval from China’s National Medical Products Administration (NMPA) and was registered on ClinicalTrials.gov (NCT06982729).

With this first patient dosing in pMN, Excyte strengthens its global footprint in autoimmune diseases alongside its oncology programs targeting non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL).

 Earlier in 2025, the company also secured approval to begin clinical trials for systemic lupus erythematosus (SLE), with Professor Xiaofeng Zeng from Peking Union Medical College Hospital as the principal investigator.

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