Release date: 2015-12-21 Luye Pharmaceutical has been strengthening the research and development of new drugs, insisting on innovation-driven development, and has made breakthroughs in recent times. Recently, Luye Pharmaceutical (HK2186) announced that it has completed two Phase I clinical trials of rotigotine sustained-release microspheres for injection (LY03003, a microsphere preparation for the treatment of Parkinson's disease). Two phase I clinical trials have shown that LY03003 is well tolerated and exhibits good pharmacokinetic characteristics and is stable in the human body, which can improve side effects, especially to ease the drug treatment in Parkinson's patients. Switch" effect. It is reported that the drug is the world's first long-term production of continuous dopamine receptor stimulating hormone (CDS) products, after the market can provide a better choice for clinical treatment of Parkinson's disease. One of the trials was a randomized, double-blind, placebo-controlled, single-dose escalation trial involving 20 healthy volunteers. The results showed that the concentration of rotigotine in plasma was proportional to the dose injected. Increased, no major security issues were observed. In the second trial, 39 patients with early Parkinson's disease were enrolled in a randomized, double-blind, placebo-controlled, multiple-dose dose escalation trial. The results showed that in five consecutive injections, plasma Rotigo The concentration of statin reached a steady state and was maintained for at least 7 days without any major safety issues observed. The multiple dose escalation trial also involved an open trial in which 20 patients were involved in assessing the pharmacokinetic profile and safety of a drug on the market, providing a reference for further study of the LY03003 dose. The selected market drug is A tablet type for treating Parkinson's disease and restless leg syndrome, which has problems in causing unstable plasma drug levels in patients, and may cause skin irritation and other side effects. Two Phase I clinical trials showed that LY03003 was well tolerated and produced good pharmacokinetic characteristics after single injection and multiple injections in different dose ranges. In addition, multiple dose escalation test results show that weekly injection of LY03003 can reach steady-state plasma concentration, which can improve efficacy and reduce side effects. According to the Journal of Neurology, Parkinson's disease is the most common active disease, and it is the second most common neurodegenerative disease. About 1 to 2% of people over the age of 65 have Parkinson's disease. In people over the age of 85, the proportion of the disease increased to 3% to 5%. Because patients with Parkinson's disease are mainly elderly, they are more common in developed countries with a longer life expectancy. According to Dr. Li Youxin, Senior Vice President of Green Leaf Pharmaceuticals, LY03003 is one of the key central nervous system research products developed by Luye Pharmaceutical on its long-acting sustained-release microsphere preparation platform, and applied for FDA in the US through 505(b)(2). registered. Luye Pharmaceutical believes that LY03003 will have a good market prospect in the future and will further enrich the Group's future product line portfolio in the field of central nervous system. Green Leaf intends to discuss with the US FDA about the next development plan for LY03003 in the United States. The drug is currently being developed simultaneously in the US, China and other markets around the world. The company has a number of patents in China and international markets covering the formulation and production processes. It is reported that in addition to LY03003, Luye Pharmaceutical has also approved a number of new drugs in the United States, of which LY03004 is a sustained release microsphere preparation for the treatment of schizophrenia (risperidone sustained release microspheres for injection). The FDA confirmed that the completed clinical study of LY03004 is sufficient to support LY03004's submission of NDA via the 505(b)(2) route without additional clinical trials. This path will significantly reduce the R&D costs and time required for LY03004 to obtain FDA approval. It is reported that Luye Pharmaceutical is currently preparing the NDA report of LY03004, which is considered to be the first Chinese new drug approved for listing in the United States. Source: China News Network Pressure Compensated Emitter Products
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Green Leaf Completes Phase I Clinical Trial of the World's First Treatment for Parkinson's Disease