The anti-tumor nano-drug independently developed by CSPC has been approved for marketing

Source: China Powder Network 137

Particle Online News: On January 11, CSPC (1093.HK) announced that the mitoxantrone hydrochloride liposome injection (10ml:10mg) developed by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. ) has obtained drug registration approval from the State Drug Administration of the People's Republic of China for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).

This product is an anti-tumor nano-drug independently developed by the Group, and is also the first mitoxantrone nano-drug on the market in the world. The product has complete intellectual property rights, and the invention patents have been authorized in more than ten countries and regions such as China, the United States, Europe, and Japan. The research and development of this product has been funded by a number of national projects such as the "National Key Research Program" and "National Major New Drug Creation Project". The design of this product adopts a unique drug-loading and drug-releasing technology, which ensures that after administration, the nanoparticles can be effectively enriched in the tumor, and the drug can be released reasonably, thereby improving the bioavailability of the drug in the tumor, resulting in Significantly improved efficacy and safety. The rational design of the product also avoids skin toxicity and infusion reactions that are prone to occur with nano-drugs.

Clinical research data shows that the clinical dose of this product can be greater than 24mg/m2, which is significantly higher than the clinical dose of mitoxantrone common injection (10~12mg/m2). The therapeutic effect of this product is significantly better than other drugs with the same indication. The product is a broad-spectrum anti-tumor nano-drug. The current clinical research data shows that the product is effective against ovarian cancer, head and neck squamous cell carcinoma, pancreatic cancer, breast cancer, small cell lung cancer, NKT cell lymphoma, soft tissue sarcoma and other tumor types. There is a significant improvement in the therapeutic effect.

In recent years, with the continuous development of nanotechnology, nanomedicines can prolong the half-life of antitumor drugs, improve the drug loading of preparations, and have strong targeting and good biological safety. Compared with normal tissues, some specific macromolecular substances are more likely to penetrate into tumor tissues and stay for a long time under the conditions of rich blood vessels, large vascular wall space and lack of tumor lymphatic circulation in solid tumors. Penetration and retention effect” (EPR), nanomedicine can promote its penetration and retention in tumor tissue through EPR effect. In addition, nanomedicine can also achieve active targeting of tumor cells by selectively recognizing highly expressed receptors and antigens in tumor cells.

In general, nanomedicines can protect loading components, improve drug accumulation and intratumoral penetration in tumor tissues, and reduce toxic and side effects on normal tissues, showing great application value and development prospects in tumor therapy. Up to now, 16 anti-tumor nano-drugs have been approved for marketing (polymer-drug conjugates and antibody-drug conjugates are not included), 8 types of liposomes, 3 types of polymer micelles and nanoparticles 5 kinds (2 kinds of inorganic nanocarriers), including intravenous injection, oral administration and intratumoral injection 3 kinds of administration routes (table below). In addition, there are a large number of nanomedicines in the clinical research stage, involving nearly 200 clinical trials.

Nano-drugs can be prepared by combining nano-carriers such as liposomes, nano-gels, and polymer micelles with drugs. The schematic diagrams of different nano-carriers are shown in the figure below. Bi et al. used transferrin-coupled liposomes to load cordycepin, which increased the endocytosis of cordycepin in liver cancer cells, and induced apoptosis of liver cancer cells by promoting the production of reactive oxygen species. Using multifunctional gold nanorods as carriers, Pacardo et al. can synergistically kill cervical cancer cells under the dual irradiation of ultraviolet and infrared. The doxorubicin-loaded multi-walled carbon nanotubes TPGS-MWCNTs prepared by Mehra et al. can kill tumor cells through endocytosis and prolong the residence time of the drug in the body. Some studies have combined dendritic macromolecules with vascular endothelial growth factor antibody Flt-1 and loaded gemcitabine, which can highly target mouse pancreatic cancer cells and increase the enrichment of the drug in tumor tissue. Zhang et al. combined siRNA with exosomes to significantly down-regulate the expression of HGF and inhibit the growth of tumor blood vessels.

At present, anti-tumor nanomedicines face severe challenges and unprecedented opportunities. The success of the Covid-19 mRNA vaccine has led to a better understanding and acceptance of nanomedicine. Anti-tumor nano-drugs show great application value and development prospects in improving the effect of cancer treatment.

In order to standardize and guide the research and evaluation of nano-drugs, in August 2021, the Drug Evaluation Center of the State Drug Administration issued the "Technical Guidelines for Nano-drug Quality Control Research (Trial)" and "Non-clinical Pharmacokinetic Research of Nano-drugs". Technical Guiding Principles (Trial)" and "Technical Guiding Principles for Nonclinical Safety Evaluation of Nano-drugs (Trial)".

With the increasing emphasis on basic research from all walks of life, the continuous innovation of delivery systems, the continuous innovation of manufacturing technology, the gradual improvement of guidelines, the further standardization of clinical research and the rapid development of supporting technologies (artificial intelligence, single-cell sequencing, etc.) It will better promote the research and development process of nano-drugs. It is believed that in the near future, more nano-drugs will be used in clinical practice, innovating tumor treatment models, and truly playing the role of innovative achievements in protecting people's health.

Reference source:

1. CSPC: Heavy! CSPC launches the world's first mitoxantrone nanomedicine

2. Wang Chaohui, Liu Yuling. Progress and prospect of clinical translation of anti-tumor nanomedicines

3. Dai Xianhua, Zhang Tingying. Research progress of antitumor drugs based on nanocarriers

4. Zhang Jinchao, Liang Xingjie. Innovative anti-tumor nanomedicine: opportunities and challenges

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