Drugs / LY01008
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2020-05-15 | “LY01008（Avastin®的 生 物 类 似 药）已 在 国 内 申 报 上 市 申 请 并 获 受 理” luye.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05110118 | Aug 2020 → Jan 2021 | colorectal cancer, non-small cell lung carcinoma | Shandong Boan Biotechnology Co., Ltd | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03533127 | Nov 2017 → Jun 2020 | non-small cell lung carcinoma | Luye Pharma Group Ltd. | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-05-15 | Luye Pharma Group Ltd. | Regulatory 绿叶制药重磅生物药地舒单抗注射液在美申报临床，国内研发进度领先 luye.com ↗
其 中，LY01008（Avastin®的 生 物 类 似 药）已 在 国 内 申 报 上 市 申 请 并 获 受 理 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-05-15 | Luye Pharma Group Ltd. | 绿叶制药重磅生物药地舒单抗注射液在美申报临床，国内研发进度领先 luye.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LY01008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05110118 ↗ |
| Modality | Monoclonal antibody | “Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection” NCT03533127 ↗ |
| Route | Intravenous | “LY01008 15 mg/kg IV every 3 weeks on Day 1” NCT03533127 ↗ |