Drugs / GenSci098
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07286656 | Nov 2025 → Oct 2026 expected | Graves disease | Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06569758 | Sep 2024 → Sep 2027 expected | endocrine exophthalmos | Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci098 Receives FDA Fast Track Designation and Advances into Phase 2 Clinical Trials genscigroup.com ↗
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. |
| 2025-06-18 | Changchun GeneScience Pharmaceutical Co., Ltd. | Results Gensci Showcases Women's Health and Immunology Innovations at BIO 2025 genscigroup.com ↗
GenSci098, a TSHR inhibitor for Thyroid Eye Disease (TED), showed rapid, durable efficacy and good safety in Phase I. |
| 2024-08-29 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci098 Injection Obtains Implied License For Clinical Trials of FDA genscigroup.com ↗
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). |
| 2024-08-06 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory Clinical Trial Commencement of GenSci098 Injection Approved genscigroup.com ↗
Recently, Changchun GeneScience Pharmaceutical Co., Ltd.(GenSci) announced that the clinical trial Commencement of GenSci098 injection has been approved by the National Medical Products Administration (NMPA). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-30 | Changchun GeneScience Pharmaceutical Co., Ltd. | GenSci098 Receives FDA Fast Track Designation and Advances into Phase 2 Clinical Trials genscigroup.com ↗ |
| 2025-06-18 | Changchun GeneScience Pharmaceutical Co., Ltd. | Gensci Showcases Women's Health and Immunology Innovations at BIO 2025 genscigroup.com ↗ |
| 2024-08-29 | Changchun GeneScience Pharmaceutical Co., Ltd. | GenSci098 Injection Obtains Implied License For Clinical Trials of FDA genscigroup.com ↗ |
| 2024-08-06 | Changchun GeneScience Pharmaceutical Co., Ltd. | Clinical Trial Commencement of GenSci098 Injection Approved genscigroup.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GenSci098 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07286656 ↗ |
| Route | Subcutaneous | “subcutaneous” NCT06569758 ↗ |