Drug Type Monoclonal antibody |
Synonyms SHR 1918, SHR1918 |
Target |
Action inhibitors |
Mechanism ANGPTL3 inhibitors(Angiopoietin like 3 inhibitors) |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hyperlipidemia, Familial Combined | Phase 3 | China | 24 Sep 2025 | |
Hyperlipidemia, Familial Combined | Phase 3 | China | 24 Sep 2025 | |
Homozygous familial hypercholesterolemia | Phase 3 | China | 30 Dec 2024 | |
Homozygous familial hypercholesterolemia | Phase 3 | China | 30 Dec 2024 | |
Hyperlipoproteinemia Type II | Phase 2 | China | 30 Nov 2023 | |
Hyperlipoproteinemia Type II | Phase 2 | China | 30 Nov 2023 |
Phase 1 | serum low-density lipoprotein cholesterol | triglyceride | 72 | nywvztpqgh(mpcijeakhs) = Treatment-emergent adverse events were comparable between the SHR-1918 (90.7%) and placebo (94.4%) groups. All treatment-emergent adverse events were mild or moderate in severity, with no serious adverse events or treatment-emergent adverse events leading to death siacsppnho (lohvwopcwq ) | Positive | 27 Jun 2025 | ||
NCT05432544 (NEWS) Manual | Phase 1 | - | yzmhuzujls(fhykbzjovf) = 300mg及以上剂量水平的LDL-C降低超过30%,持续64天以上,最高达49.1%。 yewxrqlvfm (soeuthetwg ) View more | Positive | 06 Sep 2024 | ||
Phase 1 | - | - | jjkxwsqilz(bsmhkntngl) = Treatment-emergent adverse events (TEAEs) were reported in 49 (90.7%) subjects in the SHR-1918 group and 17 (94.4%) subjects in the placebo group. The most common TEAEs were upper respiratory tract infection (25.9% with SHR-1918 vs. 27.8% with placebo), protein urine present (22.2% vs. 22.2%), and blood uric acid increased (16.7% vs. 16.7%). All TEAEs were mild or moderate in severity. There were no serious adverse events or TEAEs leading to death. ybafzrhbbu (yejasphqsn ) View more | - | 01 Sep 2024 | ||
Placebo |