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                                                                                                                                                                          迈巴赫线上娱乐:舒泰神(300204.SZ):“注射用STSP-0601”申报新药临床试验

                                                                                                                                                                          2019年05月06日 21:35 来源:join新闻网

                                                                                                                                                                          格隆汇5月6日丨舒泰神(300204)(300204.SZ)公布,公司于2019年04月30日向国家药品监督管理局提交了关于凝血因子X激活剂(项目名称“注射用STSP-0601”)的新药临床试验申请,并于同日收到申请材料签收单。

                                                                                                                                                                          公司产品“注射用STSP-0601”是国家I类治疗用生物制品,拟申请的适应症为:伴抑制物的血友病A或B患者出血按需治疗。血友病是一种X染色体连锁的隐性遗传性出血性疾病,其遗传特点是男性发病,女性携带。血友病可分为血友病A和血友病B,前者表现为凝血因子VIII(FVIII)缺乏,后者表现为凝血因子IX(FIX)缺乏,均由相应的凝血因子基因突变引起。血友病的临床特征性表现为出血倾向。主要表现为关节、肌肉和深部组织出血等。若反复出血,不及时治疗可导致关节畸形和(或)假肿瘤形成,严重者可危及生命。血友病目前仍无彻底治愈的疗法,凝血因子替代治疗是首选的治疗方法。

                                                                                                                                                                          目前国内用于伴抑制物的血友病患者出血按需治疗的药物有凝血酶原复合物浓缩物(PCC)和重组人凝血因子VIIa(rhVIIa)两种,其中,PCC存在免疫记忆反应、病毒感染等潜在风险,大剂量或连续使用与血栓形成的风险有关;rhVIIa治疗费用昂贵,限制了临床的广泛应用。因此,研发安全有效且价格可接受的治疗药物是国内伴抑制物的血友病患者急性出血发作亟待解决的临床需求。

                                                                                                                                                                          注射用STSP-0601治疗伴抑制物的血友病出血机制明确,已有的安全性和有效性数据支持开展注射用STSP-0601用于伴抑制物的血友病A或B患者出血按需治疗的临床试验。该品种研制成功,有望为伴抑制物的血友病患者提供安全、有效且经济可接受的治疗药物,从而大幅提高血友病患者接受治疗的比例,减轻患者负担,创造社会效益。