Drugs / Mitoxantrone hydrochloride liposome
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | mature T-cell and NK-cell non-Hodgkin lymphoma | 2020-08-26 | “New Drug Application for mitoxantrone hydrochloride liposome injection (new preparation) in China was submitted and accepted;” irasia.com ↗ |
Trials 10
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-08-18 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DUOENDA (MITOXANTRONE HYDROCHLORIDE LIPOSOME INJECTION) OBTAINS CLINICAL TRIAL APPROVAL FOR THE TREATMENT OF NEUROMYELITIS OPTICA SPECTRUM DISORDERS irasia.com ↗ |
| 2022-01-11 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "MITOXANTRONE HYDROCHLORIDE LIPOSOME INJECTION" OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗ |
| 2020-12-18 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - ABSTRACT OF CLINICAL TRIAL DATA OF MITOXANTRONE HYDROCHLORIDE LIPOSOME FOR RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA AND EXTRANODAL NK/T-CELL LYMPHOMA PRESENTED AT 2020 ASH ANNUAL MEETING irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, collectively the “ Group”) announces that the abstract of efficacy and safety clinical trial data of mitoxantrone hydrochloride liposome injection (HE071) independently developed by the Group for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) and extranodal NK/T-cell lymphoma (ENKTCL) has been presented at the oral session of the 2020 American Society of Hematology (ASH) Annual Meeting. |
| 2020-08-25 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF NEW DRUG APPLICATION FOR "MITOXANTRONE HYDROCHLORIDE LIPOSOME INJECTION" irasia.com ↗
submitted has been accepted by the Center for Drug Evaluation of National Medical Products Administration of the People’s Republic of China. |
| 2017-09-27 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - THE GROUP'S MALIGNANT TUMOUR TREATMENT DRUG "MITOXANTRONE HYDROCHLORIDE LIPOSOME' WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2015-01-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - THE GROUP'S ONCOLOGY DRUG WAS GRANTED PHASE II/III CLINICAL TRIAL APPROVAL irasia.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mitoxantrone hydrochloride liposome | “Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (12 mg/m2) on day 1, every 3 weeks” NCT06953739 ↗9“Mitoxantrone Hydrochloride Liposome” NCT06385808 ↗ |
| Known as | Lipo-MIT | “Mitoxantrone Hydrochloride Liposome (Lipo-MIT), a nanoparticle formulation with a 60-nm particle size, is designed to reduce toxicity and enhance tumor targeting.” PMID 42050512 ↗ Apr 20261“mitoxantrone hydrochloride liposome (Lipo-MIT)-based rituximab” PMID 42426809 ↗ Jul 2026 |
| Route | Intravenous | “intravenous injection (IV)” NCT05089461 ↗ |