GenSci's Two Innovations Received IND Clearance from NMPA

Recently, GenSci136 and GenSci155 both received IND clearance from the National Medical Products Administration (NMPA). The former is developed for systemic lupus erythematosus (SLE) and the latter is for bronchopulmonary dysplasia (BPD) and primary insulin-like growth factor 1 deficiency (PIGFD).

GenSci136: A Dual Antagonist of BAFF and APRIL

GenSci136, a BCMA fusion protein that functions as a dual antagonist of BAFF and APRIL, is intended for the treatment of SLE. SLE is a chronic, systemic autoimmune disease closely associated with impaired immune tolerance, abnormal activation of B cells, and the production of pathogenic autoantibodies. BAFF and APRIL are important cytokines in the progression of autoimmune diseases such as SLE.

Preclinical studies suggest that, by simultaneously blocking BAFF and APRIL signaling, GenSci136 has the potential to inhibit the activity of aberrantly activated B cells and antibody-secreting cells, thereby helping alleviate tissue and organ damage associated with dysregulated humoral immunity and pathogenic autoantibodies.

GenSci155: A Long-Acting IGF-1

GenSci155 is indicated for the prevention of BPD and the treatment of PIGFD. BPD is one of the most common pulmonary complications with lasting effects on respiratory function of preterm infants. Currently, there are no approved pharmacologic therapies specifically indicated for its prevention worldwide. GenSci155 offers both intravenous infusion and subcutaneous injection routes, enhancing flexibility in administration across different clinical settings.

PIGFD is a rare growth disorder caused by genetic defects in the growth hormone–IGF-1 axis. Conventional growth hormone has limited effects on the treatment of PIGFD, while existing therapies for patients with severe disease require twice-daily subcutaneous injection. With its long-acting profile, GenSci155 has the potential to enable dosing once every two to three days, laying the foundation for further exploration of this treatment approach.

GenSci is accelerating the shift from pipeline development to clinical translation, bringing more innovative therapies to patients

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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. For diagnosis and treatment information regarding specific medical conditions, please follow the advice and guidance of qualified healthcare professionals.