绿叶制药(02186.HK)盐酸安舒法辛缓释片将在日本开展临床试验
绿叶制药集团(02186.HK)宣布，其治疗抑郁症的新化合物——盐酸安舒法辛缓释片(LY03005)已在日本提交临床试验申请，即将开展临床。除在日本开发以外，LY03005也已在中国进入III期临床，并在美国进入关键试验阶段，研发进展顺利。
LY03005是绿叶制药在中枢神经领域的重磅新药之一，基于集团新型化合物平台研发而成。它是以缓释片形式制备的独家盐酸安舒法辛产品(一种5—羟色胺—去甲肾上腺素-多巴胺三重再摄取抑制剂(SNDRI))。绿叶制药计划在美国、中国、日本、欧洲及其他国家和地区注册和上市该药物。
抑郁症是中枢神经领域最常见的疾病之一，全球病患人数已超过3亿人。该疾病是全球各地的首要致残原因，也是导致全球疾病负担的一个重大因素。在日本，精神类疾病的患者人数也于近年来不断增加，其中抑郁症患者的增长尤为明显。在患者需求的推动下，2015年至2017年期间，抗抑郁药物在日本国家医疗保险(NHI)中的销售额以4.9%的年复合增长率上升，2017年达到约1586亿日元(约合14.4亿美元)。
一般而言，传统抗抑郁药物，如选择性5—羟色胺再摄取抑制剂(SSRIs)、5—羟色胺—去甲肾上腺素再摄取抑制剂(SNRIs)存在快感缺乏症、性功能障碍、无法改善认知障碍等药物缺陷，LY03005预计将比传统药物更有助于保护患者的性功能、安全性更高、起效更快、疗效更好，有望为患者提供更好的治疗选择。
绿叶制药拥有涵盖缓释片化学成份、晶体形态及制备的专利。化学成份及晶体形态的专利已在中国、美国、欧洲、日本及韩国等国家和地区获得。
LY03005所在的中枢神经领域是绿叶制药长期深耕的四大核心治疗领域之一，也是其下一阶段业务增长的关键发力点。集团围绕该治疗领域已布局一系列在研产品线。除了LY03005，治疗帕金森病的注射用罗替戈汀缓释微球(LY03003)也已在日本进入I期临床试验，并在中、美进入III期临床；治疗精神分裂症和双相情感障碍的注射用利培酮缓释微球(LY03004)已在美国正式申报NDA；另有治疗精神分裂症和分裂情感性障碍的帕利哌酮缓释混悬注射剂(LY03010)以及治疗阿尔兹海默病的利斯的明多日透皮贴剂(LY30410)等多个在研项目在中国和海外同步开发。
绿叶制药集团管理层表示：“我们十分看好这些药物的市场前景。集团将持续加大投入，加速将这些药物推向中国、美国、日本、欧洲等战略市场及全球其他市场，以帮助全球范围内更多有需要的患者。我们对于中枢神经领域产品线的布局与发展充满信心！”
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