CSPC's anticancer drug "Mitoxantrone Hydrochloride Liposome Injection" was approved for marketing

TextPharmaceutical Guanlan

Today, the official website of the China National Medical Products Administration (NMPA) announced that the listing application for "Mitoxantrone Hydrochloride Liposome Injection" submitted by CSPC Zhongnuo Pharmaceutical has been approved

Screenshot source: NMPA official website

Mitoxantrone hydrochloride liposome is a mitoxantrone liposome preparation independently developed by CSPC, which belongs to category 2.

In August 2020, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application of mitoxantrone hydrochloride liposome injection and included it in the priority review as a "conditionally approved drug".

Screenshot source: CDE official website

According to CSPC's earlier announcement, the drug's NDA application in China is mainly based on the results of a pivotal, single-arm, multi-center Phase 2 study designed to evaluate the lipid profile of mitoxantrone hydrochloride Efficacy and safety of body injection in the treatment of relapsed/refractory peripheral T-cell and extranodal NK/T-cell lymphoma (NKTCL)

According to the latest data released by CSPC in December 2021, in a conditional registration phase 2 clinical study, mitoxantrone hydrochloride liposome monotherapy is used in the treatment of relapsed/refractory PTCL and extranodal natural killer T-cell lymphoma A good anti-tumor effect was obtained

Specifically, among patients with relapsed/refractory PTCL, the patient objective response rate (ORR) was 41.

At the same time, the single drug of mitoxantrone hydrochloride liposome injection showed excellent antitumor effect on patients with immunoblastic lymphoma (AITL) subtype and extranodal nasal T-cell lymphoma (NKTCL) subtype.

In terms of safety, the adverse reactions of mitoxantrone hydrochloride liposome injection are mainly hematological toxicity

Peripheral T-cell lymphomas are a heterogeneous group of non-Hodgkin lymphomas (NHLs) originating from postthymic mature T lymphocytes or NK cells

In addition to PTCL, CSPC is currently exploring mitoxantrone hydrochloride liposome injection for the treatment of solid tumors such as small cell lung cancer, liver cancer, breast cancer, and urothelial cancer, as well as its treatment for acute myeloid leukemia, multiple myeloma, Potential for hematological malignancies such as diffuse large B lymphoma

References:

[1] China State Food and Drug Administration's January 11 Drug Approval Document Pending Information.

[3] CSPC's new drug marketing application for "Mitoxantrone Hydrochloride Liposome Injection" was accepted.

[4] CSPC's drug for the treatment of malignant tumors, "Mitoxone Hydrochloride Liposome", was granted orphan drug status by the US Food and Drug Administration.