Drugs / B001
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05145361 | Apr 2022 → Dec 2026 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Shanghai Pharmaceuticals Holding Co., Ltd | Recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03332121 | Mar 2018 → Nov 2020 | B-cell non-Hodgkin lymphoma | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06413654 | Jul 2024 → Oct 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Shanghai Jiaolian Drug Research and Development Co., Ltd | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-10-09 | Sichuan Biokin Pharmaceutical Co., Ltd. | Regulatory 四川百利天恒药业股份有限公司自愿披露关于SI-B001（EGFR×HER3双特异性抗体）联合多西他赛项目临床试验申请获得FDA批准的公告 cninfo.com.cn ↗
审批结论：FDA 已对本品完成审评，同意本品开展的临床研究。 |
| 2021-04-02 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药B001-A临床试验申请获得受理 sphchina.com ↗
近日，上海医药集团股份有限公司开发的“B001-A”临床试验申请获得国家药品监督管理局受理。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-09 | Sichuan Biokin Pharmaceutical Co., Ltd. | 四川百利天恒药业股份有限公司自愿披露关于SI-B001（EGFR×HER3双特异性抗体）联合多西他赛项目临床试验申请获得FDA批准的公告 cninfo.com.cn ↗ |
| 2021-04-02 | SPH-BIOCAD (HK) Limited | 上海医药B001-A临床试验申请获得受理 sphchina.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | B001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03332121 ↗ |
| Known as | B001 injection | “B001 injection 50mg/5mL Intravenous solution” NCT05145361 ↗ |
| Action | Deplete | “sustained B cell depletion (nearly 0/μL) for 24 weeks.” PMID 42079612 ↗ Apr 2026 |
| Modality | Monoclonal antibody | “Recombinant Humanized Anti-CD20 Monoclonal Antibody” NCT03332121 ↗ |
| Route | Intravenous | “4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77” NCT03332121 ↗ |