绿叶制药(02186.HK):CDE正式受理新药LY09606临床试验申请
格隆汇 3 月 7日丨绿叶制药(02186.HK)发布公告,集团的2类新药盐酸罗哌卡因脂质体混悬注射液(“LY09606”)临床试验申请,已获中国国家药品监督管理局药品审评中心(“CDE”)正式受理。
罗哌卡因是第一个纯左旋体长效醯胺类局麻药,有麻醉和镇痛双重效应,大剂量可产生外科麻醉,小剂量时则产生感觉阻滞(镇痛)仅伴有局限的非进行性运动神经阻滞。LY09606是一种包载罗哌卡因的多囊脂质体制剂,其独特的多囊结构对于包载的药物具有良好的缓释效应,而这是国内首个申报临床的罗哌卡因多囊脂质体注射液,可用于手术后镇痛。多囊脂质体的制备技术要求高,工艺难度大,显示集团在脂质体研发和制造领域的关键技术能力。
全球每年有超过3亿手术患者,罗哌卡因为局部麻醉药的常规用药。根据IQIVA资料,局部麻醉药在2019年于中国市场规模达到23.6亿元人民币,从2017年至2019年以23.3%的年复合增长率上升。
公告表示,集团重视脂质体制剂的研发和生产,建成了新型脂质体平台、高端载体材料平台、产业化研究平台等多个新技术平台。集团脂质体研发平台被纳入长效和靶向制剂国家重点实验室。集团已建成智慧化的脂质体生产线,产业化能力持续提升。
集团脂质体平台已取得多项重要成果。注射用紫杉醇脂质体是目前全球首个及唯一获批上市的紫杉醇脂质体产品,用于治疗非小细胞肺癌、卵巢癌、乳腺癌。盐酸伊立替康脂质体注射液(“LY01610”)处于中国临床II期阶段;伊立替康氟脲苷脂质体注射液(“LY01616”)已在中国拿到临床批准,即将开展临床研究。除此之外,集团多项脂质体产品处于临床前研究阶段。董事会相信,LY09606将进一步丰富集团中枢神经领域的产品线,从而持续推进集团在中枢神经领域的发展。
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