Clinical approval of raw materials and tablets of ruracidone hydrochloride

Shisiyao group (02005 HK) announced that it has obtained the approval documents for drug registration and clinical trials issued by the State Food and Drug Administration on the raw materials and tablets of the new antipsychotic drug lulaxione hydrochloride Lulasidone hydrochloride (trade name: latuda) is a new antipsychotic drug developed by Sumitomo pharmaceutical company in Japan, which has double effects It has a high affinity for both 5-HT2A receptor and dopamine D2 receptor It has a significant effect on both positive and negative symptoms of patients with psychosis The drug was approved by the FDA for marketing in the United States on October 28, 2010 Lulasidone is an atypical antipsychotic drug, which has high affinity for dopamine D2 receptor, 5-HT7, 5-HT2A, 5-HT1A and α 2C receptors Their Ki values were 1.68, 0.495, 2.03, 6.75 and 10.8nmol · L-1, respectively However, the affinity of the drug to 5-HT2C receptor, H1 receptor, M1 receptor and α 1 receptor was low Although the drug can effectively block the behavior of D2 receptor in vivo, the extrapyramidal symptoms (EPS) of this product are very low In addition, the drug also improved cognitive impairment in schizophrenics First, unlike other antipsychotics, it does not affect acetylcholinergic receptors or histamine H1 receptors, both of which are believed to impair learning and memory Secondly, it has high affinity to dopamine D2 receptor, 5-hydroxytryptamine 5-HT7, 5-HT2A, 5-HT1A and α 2C receptors, which are believed to improve memory impairment Finally, because of its smaller EPS (extrapyramidal symptoms), it does not need to be taken with other anticholinergic drugs In clinical research, through the comparison with other kinds of antipsychotic drugs, it is found that lulasidone has a very good effect on the treatment of patients with cognitive impairment The most common adverse reactions of lulasidone in clinical trials are drowsiness, restlessness, impulse to move (inability to sit still), nausea, abnormal movement and anxiety Although there are some adverse reactions of lulasidone, it is the most advantageous one among all antipsychotics, and has a broad market prospect At present, Sumitomo pharmaceutical company of Japan has applied for world patent wo2006092691 and Japanese patent jp2006169155 to protect the drug