GenSci098 Injection Obtains Implied License For Clinical Trials of FDA

August 26, 2024, Shanghai, China — Recently, Changchun GeneScience Pharmaceutical Co., Ltd. (hereinafter referred to as “GenSci”) announced that GenSci098 Injection (humanized anti-TSHR antagonistic monoclonal antibody), has obtained the implied license for clinical trials from the U.S. Food and Drug Administration (FDA). GenSci will conduct clinical trials aimed at treating Thyroid Eye Disease.

20 days ago, the clinical trial commencement of GenSci098 injection for the same indication was approved by NMPA.

This implied license highlights GenSci’s commitment to conducting multi-regional clinical trials and continually enriching its global R&D pipeline in line with world-class R&D standards.

As a pioneer in pediatric and women's health, Gensci is actively advancing into the international market with innovative products, transitioning from a single industry leader domestically to a diversified global player with a broad portfolio.