Drugs / XNW5004
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2026-09-15 | “公司马来酸依格美妥司他片（XNW5004）的药品上市许可申请获国家药监局受理。” evopointbio.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06022757 | Sep 2023 → Aug 2028 expected | cervical cancer, head and neck squamous cell carcinoma, non-small cell lung carcinoma, prostate cancer +2 | Evopoint Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06702995 | Apr 2023 → May 2026 overdue | castration-resistant prostate carcinoma | Evopoint Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06558513 | Aug 2021 → Aug 2025 | high grade malignant neoplasm, lymphoma | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07545603 | Feb 2026 → Dec 2027 expected | follicular lymphoma | Evopoint Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06702605 | Nov 2024 → Jan 2027 expected | peripheral T-cell lymphoma, not otherwise specified | Evopoint Biosciences Inc. | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06776952 | Apr 2025 → Jan 2028 expected | peripheral T-cell lymphoma, not otherwise specified | Evopoint Biosciences Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | Evopoint Biosciences Inc. | Regulatory 信诺维抗肿瘤1类新药马来酸依格美妥司他片NDA申请获受理并纳入优先审评 evopointbio.com ↗
公司马来酸依格美妥司他片（XNW5004）的药品上市许可申请获国家药监局受理。 |
| 2026-02-27 | Evopoint Biosciences Inc. | Results 信诺维于ASCO GU公布依格美妥司他（XNW5004）治疗mCRPC最新数据，mrPFS超18个月 evopointbio.com ↗
疗效结果显示，整体阿比特龙治疗失败以及1200mg剂量组患者的中位影像学无进展生存期（mrPFS）均为18.6m，mOS均未达到（95% 置信区间：18.56 - 未达到）。 |
| 2025-02-14 | Evopoint Biosciences Inc. | Regulatory 目标一线疗法！XNW5004获批PTCL重要临床研究 evopointbio.com ↗
2025年2月12日，信诺维医药科技股份有限公司（简称“信诺维”或“公司”）自主研发的创新药EZH2 抑制剂——XNW5004获得国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》，将于近期开展XNW5004联合CHOP/CHOEP拟用于治疗初治外周T细胞淋巴瘤（PTCL）的Ib/II期临床研究。 |
| 2024-09-10 | Evopoint Biosciences Inc. | Regulatory 信诺维EZH2抑制剂XNW5004获突破性治疗品种认定 evopointbio.com ↗
公司自主研发的创新药 EZH2 抑制剂——XNW5004，已正式获得突破性治疗药物品种认定，用于治疗复发或难治性外周 T 细胞淋巴瘤（PTCL）。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | Evopoint Biosciences Inc. | 信诺维抗肿瘤1类新药马来酸依格美妥司他片NDA申请获受理并纳入优先审评 evopointbio.com ↗ |
| 2026-02-27 | Evopoint Biosciences Inc. | 信诺维于ASCO GU公布依格美妥司他（XNW5004）治疗mCRPC最新数据，mrPFS超18个月 evopointbio.com ↗ |
| 2025-02-14 | Evopoint Biosciences Inc. | 目标一线疗法！XNW5004获批PTCL重要临床研究 evopointbio.com ↗ |
| 2024-09-10 | Evopoint Biosciences Inc. | 信诺维EZH2抑制剂XNW5004获突破性治疗品种认定 evopointbio.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | XNW5004 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06702995 ↗ |
| Action | Inhibit | “XNW5004 an EZH2 inhibitor, BID, administered in continuous” NCT06022757 ↗ |
| Route | Oral | “XNW5004 will be administered orally as tablets.” NCT06702605 ↗ |
| Target | EZH2 | “XNW5004 an EZH2 inhibitor, BID, administered in continuous” NCT06022757 ↗ |