GenSci098 Receives FDA Fast Track Designation and Advances into Phase 2 Clinical Trials

Recently, GenSci098 (YB-101), an innovative anti-TSHR antibody, has advanced into Phase 2 clinical trials for Graves’ disease (GD) and thyroid eye disease (TED) and reached First Patient In (FPI), following its FDA Fast Track Designation.

The Phase 2 clinical trial, which is being conducted in the US and Australia by our partner Yarrow Bioscience, Inc., is a randomized, blinded, placebo-controlled trial evaluating GenSci098 (YB-101) in patients with GD, with or without concurrent TED. Meanwhile, GenSci is advancing Phase 1 clinical trials of GenSci098 for TED and GD in China, showing encouraging clinical results and favorable safety profile, with no IGF-1R inhibitor-related adverse reaction, such as hearing impairment or hyperglycemia. The clinical data is expected in 2027.

GenSci098 is an anti-thyroid stimulating hormone receptor (TSHR) monoclonal antibody designed to directly disrupt the central mechanism of both GD and TED, with the potential to offer a single targeted treatment to address both diseases. The candidate also supports convenient subcutaneous administration and low-frequency dosing, demonstrating differentiated therapeutic potential.

Yarrow’s CEO Rebecca Frey said, “YB-101 offers an entirely new treatment approach through TSHR blockade, which we believe is the most direct way to disrupt the underlying disease process and has the potential to meaningfully improve outcomes for patients living with GD and TED.”

"The rapid clinical advancement of GenSci098, our first out-licensed asset, powerfully underscores our global development strategy we embedded from the outset. We remain fully committed to developing our pipeline globally, bringing transformative therapies to patients worldwide.” noted Lei Jin, CEO of GenSci.

Through strategic collaboration with global partners, GenSci will continue to accelerate the translation of scientific breakthroughs into clinical solutions and contribute to the advancement of global healthcare.

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1. Innovative drug research and development entails high risks and uncertainties.

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.