"Mitoxantrone Hydrochloride liposome" of Shijiazhuang Pharmaceutical Group has obtained FDA orphan drug qualification certification

Source: Medical Rubik's cube data on September 27, 2017, stone Pharmaceutical Group announced that FDA granted its orphan drug qualification of Mitoxantrone Hydrochloride liposome in the treatment of peripheral T-cell lymphoma (PTCL) Mitoxantrone is a broad-spectrum anti-tumor drug widely used in clinic Because of its serious cardiotoxicity and myelosuppression, its clinical application is seriously limited After mitoxantrone was made into lipid formulation, the drug's pharmacokinetics, tissue distribution, efficacy and toxicity had significant changes Compared with the ordinary preparation, the efficacy and safety of mitoxantrone were significantly increased Mitoxantrone Hydrochloride liposome is independently developed by the group of Chinese Materia Medica, and there is no report of this product in the world at present Sinopharm group has independent intellectual property rights in this project It has applied for 7 domestic patents and 2 international patents, and has been authorized by the European Union and other 10 countries The United States, Japan and other 7 countries are under trial The product is currently in phase II clinical trials in China The most important significance of orphan drug qualification is to get more guidance from the U.S FDA, and have the opportunity to communicate with the FDA widely In some cases, it can also reduce part of the clinical trials and accelerate the speed of product marketing In addition, orphan drugs in the United States can enjoy 7 years of market monopoly and up to 50% tax relief of R & D expenses Sinopharm group is now fully promoting the clinical research of the product in the United States, striving to apply for listing in China and the United States at the same time by 2020 or before.