Stone Pharmaceutical Group's application for the listing of anticancer drugs is to be included in the priority review

Recently, China's State Drug Administration Drug Review Center (CDE) website published information that Shi Pharmaceutical Group, China No. 1 Pharmaceuticals submitted the "hydrochloric acid mitochondrial lipid body injection" listing application is to be included in the priority review, on the grounds that "qualified drugs approved." The drug is applied for in patients with relapsed or incurable external T-cell lymphoma (PTCL).

the hydrochloric acid mitoxone lipid body is the self-developed mitoxyquinone lipid system agent, is a 2.2 class of improved new drugs, stone pharmaceutical group has full intellectual property rights. In 2017, the FDA granted the drug orphan status for the treatment of external T-cell lymphoma.According to the stone pharmaceutical group announcement, mitoxine is a wide-spectrum broad-spectrum anti-tumor drug clinically used, because of its severe heart toxicity and bone marrow inhibition and other adverse reactions, the clinical application of the drug is severely restricted. After the mitoquinium was made into lipid system agent, the drug's drug generation, tissue distribution, efficacy and toxicity produced significant changes, compared with ordinary preparations, the efficacy and safety increased significantly.The drug's new drug listing application in China is based on a single-arm, open, multi-center Phase 2 study aimed at evaluating the effectiveness of hydrochloric acid mitothoquine liposome injections in the treatment of recurring/difficult-to-treat external T-cells and NK/T-cell lymphomas. The adaptation to this application is - suitable for patients with recurrence or incurable external T-cell lymphoma who have been treated with at least one line of standard treatment in the past.China Drug Clinical Trial Registration and Information Disclosure Platform information shows that, in addition to the external T-cell lymphoma, Shi Pharmaceutical Group also registered a number of clinical trials on hydrochloric acid mitothoid lipid body injection, covering a variety of cancers including extraterrestrial nasal NK/T cell lymphoma, second-line treatment of small cell lung cancer, late recurrence or metastatic breast cancer, advanced hepatocellular carcinoma and many other cancers. (
Medical Mission
)