IND Approval: GenSci136 Advances into Sjögren's Syndrome

Recently, GenSci136 received IND approval from the National Medical Products Administration (NMPA) for the treatment of Sjögren's syndrome.

Sjögren's syndrome is a chronic systemic autoimmune disorder characterized by lymphocytic infiltration and damage to exocrine glands, with dry mouth and dry eyes as typical symptoms. The estimated global prevalence is 0.01%–0.05%[1], and it predominantly affects women. Current treatment approaches leave room for improvement in restoring glandular function, managing fatigue and pain, and achieving sustained disease control, highlighting a clear need for new therapeutic options.

GenSci136 is a dual antagonist targeting B-cell activating factor (BAFF, also known as BLyS) and a proliferation-inducing ligand (APRIL), cytokines that play important roles in the progression of autoimmune diseases. By simultaneously blocking BAFF and APRIL signaling, GenSci136 has the potential to more comprehensively inhibit the survival and function of dysregulated B cells and antibody-secreting cells, thereby mitigating tissue and organ damage mediated by aberrant humoral immunity and pathogenic autoantibodies. Preclinical studies show good in vivo pharmacological activity with a prolonged duration of action and an acceptable safety profile, supporting further clinical development.

The latest IND approval further expands GenSci's clinical research footprint in autoimmune diseases. Guided by clinical value, the company will continue to actively advance clinical development of this product to provide more diverse treatment options for patients worldwide.

Disclosure Notice:

1. Innovative drug development entails high risks, and the outcome of clinical trials remains uncertain.

2. This press release is provided as a medical information source for healthcare experts only and is not used for commercial purposes.

3. GenSci does not recommend the use of any unapproved drugs or indications.

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