Drug Type Monoclonal antibody |
Synonyms 艾心安 |
Target |
Mechanism PCSK9 inhibitors(Proprotein convertase subtilisin kexin type 9 inhibitors) |
Active Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (08 Jan 2025), |
RegulationSpecial Review Project (CN) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Complex dyslipidemia | CN | 10 Jan 2025 | |
Hypercholesterolemia | CN | 10 Jan 2025 | |
Primary hypercholesterolemia | CN | 08 Jan 2025 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hyperlipidemia, Familial Combined | Phase 3 | CN | 30 Jul 2021 | |
Hyperlipoproteinemia Type II | Phase 3 | CN | 30 Jul 2021 | |
Hyperlipoproteinemia Type III | Phase 3 | CN | 23 Apr 2021 | |
Hyperlipoproteinemia Type V | Phase 3 | CN | 23 Apr 2021 | |
Homozygous familial hypercholesterolemia | Phase 3 | - | 01 Sep 2020 | |
Hypercholesterolemia, Autosomal Dominant, 3 | Discovery | CN | 14 Apr 2021 |
Phase 3 | 703 | recaticimab at 150 mg every 4 weeks | (egyqpnfrfw) = Safety with recaticimab was comparable to placebo. the most common treatment-related adverse event was injection site reaction (n = 23 [4.9%]). vllklquzzr (mvctepbykl ) | Positive | 23 Oct 2024 | ||
recaticimab at 300 mg every 8 weeks | |||||||
Phase 3 | 689 | recaticimab 150 mg (injection every 4 weeks) | (lkyzcggbra) = At every dosage/interval, participants who received recaticimab had lower bad cholesterol levels at 24 weeks than those receiving a placebo.
In the 4-week injection group, bad cholesterol was reduced 62% among those taking recaticimab vs. 0% among those in the placebo group; in the 8-week injection group, bad cholesterol was reduced 59% vs. +0.4% respectively; and in the 12-week injection group bad cholesterol was reduced 51% vs. +2% respectively.
At every dosage/interval, recaticimab lowered their bad cholesterol to the target by 24 weeks compared to the placebo and these levels were maintained at 48 weeks. fiwozxfxer (cgdvxdixtb ) View more | Positive | 13 Nov 2023 | ||
Placebo (injection every 4 weeks) | |||||||
NCT03944109 (Pubmed) Manual | Phase 1/2 | 110 | (tiufckszcu) = No serious treatment-emergent adverse events (TEAEs) occurred. vwjcsqggcr (szhgqpmzrc ) View more | Positive | 18 Jan 2022 | ||
Placebo |