drugset / Press release

GenSci098 Injection Obtains Implied License For Clinical Trials of FDA

2024-08-29 · Changchun GeneScience Pharmaceutical Co., Ltd. · original genscigroup.com ↗

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. Previous: GenSci Invites You to Meet Us at Pharmedi Vietnam 2024 Next: Jintrolong® New Dosage Form of Long-acting Somatropin Injection Approved Recommended News 2026-09-03 GenSci Showcases Innovation at CPHI Korea 2026 2026-08-13 GenSci's Ophthalmology Pipeline: IND Approval Secured for Three Indications 2026-07-31 GenSci144, a Novel SLC6A19 Inhibitor, Receives IND Approval from NMPA

The release as fetched from its publisher. genscigroup.com ↗