Drugs / SG301
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2020-07-24 | “向国家药品监督管理局（NMPA）药品审评中心（CDE）提交的抗CD38人源化单克隆抗体（SG301）新药临床试验申请（IND）获正式受理” sumgenbio.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06144710 | Nov 2023 → Jan 2026 overdue | systemic lupus erythematosus | Hangzhou Sumgen Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04684108 | Nov 2021 → Jun 2024 overdue | refractory plasma cell neoplasm | Hangzhou Sumgen Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07710248 | Jun 2026 → May 2027 expected | primary thrombocytopenia | Hangzhou Sumgen Biotech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07447986 | Mar 2026 → Sep 2027 expected | systemic lupus erythematosus | Hangzhou Sumgen Biotech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07087314 | Aug 2025 → Jul 2028 expected | nephrotic syndrome | Mao Jianhua | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-06-29 | Hangzhou Sumgen Biotech Co., Ltd. | Regulatory 尚健生物皮下注射新药SG301 SC获国家药品监督管理局批准临床试验 sumgenbio.com ↗
SG301 SC注射液获得国家药品监督管理局（NMPA）批准开展临床试验，适应症为系统性红斑狼疮。 |
| 2020-07-24 | Hangzhou Sumgen Biotech Co., Ltd. | Regulatory 中国首个自主研发的抗CD38单克隆抗体药物临床试验申请获受理 sumgenbio.com ↗
2020年7月24日，杭州尚健生物技术有限公司（尚健生物，Sumgen）宣布其向国家药品监督管理局（NMPA）药品审评中心（CDE）提交的抗CD38人源化单克隆抗体（SG301）新药临床试验申请（IND）获正式受理。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-29 | Hangzhou Sumgen Biotech Co., Ltd. | 尚健生物皮下注射新药SG301 SC获国家药品监督管理局批准临床试验 sumgenbio.com ↗ |
| 2020-07-24 | Hangzhou Sumgen Biotech Co., Ltd. | 中国首个自主研发的抗CD38单克隆抗体药物临床试验申请获受理 sumgenbio.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SG-301 | “SG-301 SC monotherapy Weekly dosing for 8 doses” NCT07710248 ↗ |
| Modality | Monoclonal antibody | “Anti-CD38 Monoclonal Antibody” NCT07087314 ↗ |
| Route | Intravenous | “by IV infusion” NCT04684108 ↗ |
| Target | CD38 | “Anti-CD38 Monoclonal Antibody” NCT07087314 ↗ |