Green leaf pharmaceutical new prostate cancer drug approved by FDA

Green leaf Pharmaceutical (02186 HK) announced that the group's in-process product, geserelin acetate sustained-release microspheres for injection (ly01005), has been approved by the U.S Food and Drug Administration (FDA) for clinical trials in the treatment of prostate cancer The Group believes that goserellin acetate microspheres have similar bioavailability compared with another market product (goserellin implant), but have better patient compliance and more stable efficacy The group has submitted patent cooperation agreement (PCT) application for goserellin microsphere pharmaceutical composition in 2014, which has entered the United States, Europe, Japan and several other countries in 2015 In addition to ly01005, the group is developing a variety of new drugs in the United States, including risperidone sustained-release microspheres for injection (ly03004), which have been confirmed by FDA to submit new drug applications in the United States without any further clinical trials; the first phase of clinical trials has been completed in the United States for the sustained-release tablets of anshufaxine hydrochloride (ly03005) and the sustained-release microspheres of rotigotine for injection (ly03003) Extension: Tian Jingwei, director of non clinical research department of R & D center of green leaf Pharmaceutical Group, held the first "made in China" pharmaceutical innovation communication forum hosted by China Pharmaceutical News and Information Association in Beijing recently Green leaf Pharmaceutical Co., Ltd., a practical pharmaceutical company, shares experience that pharmaceutical companies should find niche market vacancies and strive to explore their own growth points
Tian Jingwei, director of non clinical research department of R & D center of LVYE Pharmaceutical Group, introduced in the speech of "innovation, achievement and excellence - the way to explore the internationalization of LVYE pharmaceutical" LVYE pharmaceutical's vision is to "become the most respected global leading pharmaceutical enterprise" Based on R & D and innovation, the company is committed to providing high-quality pharmaceutical products, such as psychoneurology, oncology, oncology and oncology There is a strategic layout in cardiovascular, endocrine and other fields; at present, the proportion of products with patent protection accounts for 86.2% of the total revenue, with a rich product line under research (including 21 products under research in China and 7 products under research overseas) Tian Jingwei mainly introduced the research progress of four projects, including risperidone sustained-release microspheres for injection (ly03004), rotigotine sustained-release microspheres for injection (ly03003), and goserellin sustained-release microspheres for injection (ly01005) Among them, risperidone sustained-release microspheres for injection are designed for the major defects and clinical needs of the marketed products Through the simultaneous clinical research in the United States and China, on September 10, 2015, based on the key clinical data completed by LVYE pharmaceutical, FDA agreed that the product entered the NDA (new drug marketing license application to the United States FDA after the completion of the clinical trial) stage, which is expected to become a medium-sized drug China's first innovative drug listed in the United States The new anti-inflammatory drug maitongna (aescin sodium) originated from the natural drug (β - aescin sodium) listed in Germany, but they have different material basis, quality control methods and safety Fu Fenghua, the R & D expert of LVYE pharmaceutical and Dean of the school of pharmacy of Yantai University, systematically shared the R & D experience with the participants from the research on the function characteristics and new mechanism of maitongna, the formulation of quality standards, the protection of intellectual property rights, and the innovation of production technology and process Above source: astak finance and economics network, Chinanet