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绿谷糖药物生产基地正式封顶 有望惠及全球阿尔茨海默病患者

9月29日,绿谷糖药物生产基地在上海国际医学园区正式完成主体结构全面封顶,这是自2020 年7月17日开工奠基以来的一大重要进展。继上海青浦基地和辽宁本溪基地之后,这将是绿谷制药旗下的第三个GMP标准生产基地,更将是全球首个符合中国和美国GMP标准的糖药物生产基地,致力于保证生产质量与国际接轨,作为中国首个糖药物出口全球的生产基地,承载中国原创药物国际化的重要使命,有望惠及全球阿尔茨海默病(AD)患者。

该项目投资合计12.27亿元,面积将达到5.5万平方米,预计于2024年底前完成验收并投入运行,将极大提升中国原研创新药甘露特钠胶囊(商品名:九期一®)以及绿谷制药后续系列糖药物产能,甘露特钠胶囊年产量将高达60亿粒,满足超240万阿尔茨海默病患者的用药需求。

阿尔茨海默病已成为严重危害全球老年人健康和生活质量的疾病之一。据2020年世界卫生组织发布的《2019年全球卫生估计报告》显示,在过去20年,全球十大死因中,仅阿尔茨海默病和其他形式的痴呆症就跻身全球十大死因之列。据第七次全国人口普查数据显示,我国现有60岁以上人口占总人口数的18.7%,伴随着我国老龄化问题的逐渐加重,阿尔茨海默病发病率会逐渐增加。目前,我国约有1000万阿尔茨海默病患者,预计到2050年,将突破4000万。

糖科学和糖药物已成为21世纪生命科学研究以及新药研发的重要组成部分,科学研究发现,糖类不仅仅是传统认知中的能量物质,还参与了生命遗传和生物合成中的一些关键步骤1。研究表明,糖药物具有抗凝血、降血脂、抗菌、抗病毒、抗肿瘤、抗衰老和增强免疫等多种生物活性2,这意味着糖药物研发将在未来的临床医学和生物科学领域中发挥更为重要的作用。

中国原创新药甘露特钠胶囊正是糖药物研发成功的代表之一,已在2019年11月2日获批上市。甘露特钠胶囊是以海洋褐藻提取物为原料,制备获得的低分子酸性寡糖化合物,不仅是全球首个抗阿尔茨海默病的糖类药物,更是填补了该疾病领域全球17年无新药上市的空白。作为一款作用于脑肠轴机制的疾病修饰类药物,甘露特纳胶囊打破了我国AD领域长期无新药可用的困局,为我国AD患者提供了新的治疗选择。

作为研发驱动的创新药企,绿谷制药始终坚持以整体观、“脑-肠轴”理论为核心,以糖药物为手段探索人类攻克慢性复杂疾病的治疗方案,研发患者最期盼的药物,提升人类认知健康。绿谷制药在糖药物创新领域积累了超过20年的理论、经验和技术,绿谷研究院已从上千种植物、微生物及海洋生物中提取、分离、化学修饰得到了7500多个多糖和寡糖样本,形成了国际领先的、有自主知识产权的糖化合物库,并以此为基础,建立了独特的糖药物研发管线,包括数十个临床前先导化合物,覆盖肿瘤、神经精神系统疾病、自身免疫性疾病等多个重大疾病领域。

目前甘露特钠胶囊国际多中心Ⅲ期临床试验已全面开展,这是一项为期52周的多中心随机、双盲双臂、平行组安慰剂对照、单药疗法临床试验,将在北美、欧洲和中国等14个国家和地区分别设立大约200家临床中心,涉及2046名轻度至中度阿尔茨海默病患者。在双盲期之后,还将开展为期26周的开放试验。其52周双盲期研究计划在2025年全部完成,将于之后开展欧美地区的新药注册上市工作,有望惠及全球AD患者。

参考文献:

[1] 尹健,叶新山. 糖化学:糖类药物研发的重要驱动力[J]. 药学进展,2020,44(7):481-483

[2] 吴立根, 毛文君. 衍生化多糖的生物活性研究进展[J]. 海洋科学, 2002, 26(5):23-25

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