Drugs / IMM47
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | solid adenocarcinoma with mucin production | 2023-09-13 | “此外，IMM47治疗实体瘤的IND申请已获得国家药品监督管理局 (NMPA) 受理” immuneonco.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05985083 | Aug 2023 → Dec 2024 | — | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-10-16 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Regulatory 宜明昂科CD24靶向候选人源化抗体药物IMM47临床试验申请获得国家药品监督管理局 (NMPA) 批准 immuneonco.com ↗
2023年10月16日，宜明昂科生物医药技术(上海)股份有限公司（简称“宜明昂科”，香港交易所股票代码：01541.HK）宣布，公司自主研发的人源化IgG1 CD24抗体药物 (项目编号: IMM47）的临床试验申请获得国家药品监督管理局 (NMPA) 批准，这是宜明昂科公司快速发展中取得的又一里程碑成就。 |
| 2023-09-13 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Results 宜明昂科IMM47临床前研究结果在《Antibody Therapeutics》上发表 immuneonco.com ↗
文章通过体外体内实验阐述了IMM47对肿瘤细胞的杀伤作用机制以及强大的抑制肿瘤生长的能力。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-16 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | 宜明昂科CD24靶向候选人源化抗体药物IMM47临床试验申请获得国家药品监督管理局 (NMPA) 批准 immuneonco.com ↗ |
| 2023-09-13 | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | 宜明昂科IMM47临床前研究结果在《Antibody Therapeutics》上发表 immuneonco.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMM47 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05985083 ↗ |
| Modality | Monoclonal antibody | “humanized mAb” NCT05985083 ↗ |
| Route | Intravenous | “administered via intravenous infusion” NCT05985083 ↗ |
| Target | CD24 | “targeting CD24” NCT05985083 ↗ |