Drugs / GenSci128
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06908434 | Jun 2025 → Dec 2027 expected | — | Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-03-11 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory GenSci128, an Investigational Cancer Therapy from Gensci Pharmaceuticals, Receives FDA Orphan Drug Designation for Pancreatic Cancer genscigroup.com ↗
Changchun GeneScience Pharmaceutical Co., Ltd. ("GenSci") recently announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its novel investigational therapeutic, GenSci128, for the treatment of pancreatic cancer. |
| 2026-01-16 | Changchun GeneScience Pharmaceutical Co., Ltd. | Results GenSci Unveils Seven Innovative Pipeline at JPM 2026 genscigroup.com ↗
GenSci128 demonstrated proof of mechanism in patients with advanced solid tumors harboring TP53 Y220C mutation and has demonstrated favorable efficacy and safety in preclinical studies. |
| 2025-05-30 | Changchun GeneScience Pharmaceutical Co., Ltd. | Regulatory The FDA has Cleared the IND Application for GenSci128 for TP53 Y220C-Mutated Solid Tumors genscigroup.com ↗
On May 28, 2025 , Changchun GeneScience Pharmaceutical Co., Ltd. (GenSci) announced that GenSci128 has officially received clearance from the U.S. FDA, which is indicated for locally advanced or metastatic solid tumors with TP53 Y220C mutation. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-11 | Changchun GeneScience Pharmaceutical Co., Ltd. | GenSci128, an Investigational Cancer Therapy from Gensci Pharmaceuticals, Receives FDA Orphan Drug Designation for Pancreatic Cancer genscigroup.com ↗ |
| 2026-01-16 | Changchun GeneScience Pharmaceutical Co., Ltd. | GenSci Unveils Seven Innovative Pipeline at JPM 2026 genscigroup.com ↗ |
| 2025-05-30 | Changchun GeneScience Pharmaceutical Co., Ltd. | The FDA has Cleared the IND Application for GenSci128 for TP53 Y220C-Mutated Solid Tumors genscigroup.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GenSci128 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06908434 ↗ |
| Route | Oral | “GenSci128 will be orally administrated daily (except single dose in Cycle 0)” NCT06908434 ↗ |