四川奥邦药业磺达肝癸钠项目通过与四川大学华西药学院秦勇团队合作,历经多年研发,采用全新合成路线,将原研繁琐的总75步合成步骤减少到52步,其线性45步骤缩减至23步,大大降低了工业化难度和提高合成效率。
在整个路线的设计中,不仅解决了多手性中心复杂分子的立体化学控制问题,还避免了许多步骤的过柱纯化,使得该技术更利于工业化,目前已经申请专利并获得授权CN201510591442.2。
磺达肝癸钠原料药目前全球用量约100kg/年,目前原料药国际市场价格约300-400万RMB /kg,原料药市场规模约3-4亿RMB。目前该原料药项目我公司已经于2022.03月向国家药审中心提交了申报资料并于2023.04提交了发补资料,并于2023.10获得批文(中国原料药登记号:Y20210001161)于2023.06提交美国DMF资料并受理。
磺达肝癸钠CAS号:114870-03-0
磺达肝癸钠分子式: C31H43N3Na10O49S8
磺达肝癸钠英文名称: Fondaparinux sodium
磺达肝癸钠英文同义词: decasodium (2R,3S,4S,5R,6R)-3-[(2R,3R,4R,6R)-5-[(2R,3R,4S,5S,6S)-6-carboxylato-5-[(2R,3R,4R,5S,6R)-4,5-dihydroxy-3-(sulfonatoamino)-6-(sulfonatooxymethyl)oxan-2-yl]oxy-3,4-dihydroxy-oxan-2-yl]oxy-3-(sulfonatoamino)-4-sulfonatooxy-6-(sulfonatooxymethyl)oxan-2-yl]oxy-4-hydroxy-6-[(2R,3S,4R,5R,6S)-4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-(sulfonatooxymethyl)oxan-3-yl]oxy-5-sulfonatooxy-oxane-2-carboxylate; decasodium (2R,3S,4S,5R,6R)-3-({(2R,3R,4R,5R,6R)-5-{[(2R,3R,4R,5S,6S)-6-carboxylato-5-({(2R,3R,4R,5S,6R)-4,5-dihydroxy-3-(sulfonatoamino)-6-[(sulfonatooxy)methyl]tetrahydro-2H-pyran-2-yl}oxy)-3,4-dihydroxytetrahydro-2H-pyran-2-yl]oxy}-3-(sulfonatoamino)-4-(sulfonatooxy)-6-[(sulfonatooxy)methyl]tetrahydro-2H-pyran-2-yl}oxy)-4-hydroxy-6-({(2R,3S,4R,5R,6S)-4-hydroxy-6-methoxy-5-(sulfonatoamino)-2-[(sulfonatooxy)methyl]tetrahydro-2H-pyran-3-yl}oxy)-5-(sulfonatooxy)tetrahydro-2H-pyran-2-carboxylate (non-preferred name)
磺达肝癸钠分子量: 1728.0815