Drugs / M701
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04501744 | Sep 2018 → Feb 2022 | cancer | Wuhan YZY Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05543330 | Sep 2022 → Sep 2026 overdue | non-small cell lung carcinoma, pleural neoplasm | Wuhan YZY Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06266091 | Nov 2021 → Feb 2024 | peritoneal neoplasm | Wuhan YZY Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06432296 | Mar 2024 → Jun 2026 overdue | peritoneal neoplasm | Wuhan YZY Biopharma Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-07-04 | Wuhan YZY Biopharma Co., Ltd. | Regulatory 友芝友生物：EpCAM/CD3双特异性抗体（M701）获得胸水适应症临床试验批准 yzybio.com ↗
2022年7月4日，武汉友芝友生物制药股份有限公司（以下简称“友芝友生物”）自主研发的“注射用重组抗EpCAM和CD3 双特异性抗体”（代号：M701），获得国家药品监督管理局（NMPA）临床试验默示许可（受理号：CXSL2200178），公司将依据临床批件的要求，近期在浙江省肿瘤医院等多家中心开展M701治疗恶性胸水的Ib/II期临床研究。 |
| 2021-11-25 | Wuhan YZY Biopharma Co., Ltd. | Regulatory 探索腹腔灌注注射用重组抗EpCAM和CD3人鼠嵌合双特异性抗体在晚期上皮性实体瘤伴恶性腹水患者中的II期临床研究进行中 yzybio.com ↗
本研究已获得国家药品监督管理局的批准。 |
| 2021-09-13 | Wuhan YZY Biopharma Co., Ltd. | Results 2021年ESMO年会EpCAM/CD3双抗治疗恶性腹水I期临床试验研究中期成果已上线 yzybio.com ↗
M701药物已经在卵巢癌和胃癌患者中初步展示出改善总生存期的趋势。 |
| 2021-09-03 | Wuhan YZY Biopharma Co., Ltd. | Results 友芝友生物将在2021年欧洲肿瘤内科学会（ESMO）大会公布EpCAM/CD3双抗最新临床数据 yzybio.com ↗
临床数据显示，M701表现出良好的安全性和耐受性，无细胞因子释放综合征（CRS）出现。 |
| 2019-10-31 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "RECOMBINANT ANTI-EpCAM AND ANTI-CD3 HUMAN-MOUSE CHIMERIC BISPECIFIC ANTIBODY FOR INJECTION" WAS GRANTED CLINICAL TRIAL APPROVAL BY U.S. FDA irasia.com ↗
This is the second product candidate of YZY Biopharma granted clinical trial approval by the U.S. FDA this year. |
| 2018-03-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "RECOMBINANT ANTI-EpCAM AND ANTI-CD3 HUMAN-MOUSE CHIMERIC BISPECIFIC ANTIBODY FOR INJECTION" WAS GRANTED DRUG CLINICAL TRIAL APPROVAL irasia.com ↗ |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-01 | Wuhan YZY Biopharma Co., Ltd. | 友芝友生物 M701 II 期临床成果登国际知名期刊 EHO 恶性腹水治疗获突破性进展 yzybio.com ↗ |
| 2022-07-04 | Wuhan YZY Biopharma Co., Ltd. | 友芝友生物：EpCAM/CD3双特异性抗体（M701）获得胸水适应症临床试验批准 yzybio.com ↗ |
| 2021-11-25 | Wuhan YZY Biopharma Co., Ltd. | 探索腹腔灌注注射用重组抗EpCAM和CD3人鼠嵌合双特异性抗体在晚期上皮性实体瘤伴恶性腹水患者中的II期临床研究进行中 yzybio.com ↗ |
| 2021-09-13 | Wuhan YZY Biopharma Co., Ltd. | 2021年ESMO年会EpCAM/CD3双抗治疗恶性腹水I期临床试验研究中期成果已上线 yzybio.com ↗ |
| 2021-09-03 | Wuhan YZY Biopharma Co., Ltd. | 友芝友生物将在2021年欧洲肿瘤内科学会（ESMO）大会公布EpCAM/CD3双抗最新临床数据 yzybio.com ↗ |
| 2019-10-31 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - "RECOMBINANT ANTI-EpCAM AND ANTI-CD3 HUMAN-MOUSE CHIMERIC BISPECIFIC ANTIBODY FOR INJECTION" WAS GRANTED CLINICAL TRIAL APPROVAL BY U.S. FDA irasia.com ↗ |
| 2018-03-16 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | VOLUNTARY ANNOUNCEMENT - "RECOMBINANT ANTI-EpCAM AND ANTI-CD3 HUMAN-MOUSE CHIMERIC BISPECIFIC ANTIBODY FOR INJECTION" WAS GRANTED DRUG CLINICAL TRIAL APPROVAL irasia.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | M701 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06432296 ↗ |
| Modality | Monoclonal antibody | “Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody” NCT06266091 ↗ |
| Route | Other | “M701 pleural infusion” NCT05543330 ↗ |
| Target | EPCAM | “M701, a Recombinant Epcam and CD3 Bispecific Antibody” NCT05543330 ↗ |