荣昌生物-B(09995.HK)：泰它西普获批准在中国有条件上市
格隆汇3月11日丨荣昌生物-B(09995.HK)公告，公司自主研发的双靶向融合蛋白药物泰它西普（RC18，商品名：泰爱）正式获得中国国家药品监督管理局(NMPA)在中国的有条件上市的批准，用于治疗系统性红斑狼疮(SLE)。
泰它西普（RC18，商品名：泰爱）获准上市销售是集团的一项重大里程碑，体现了集团在自身免疫疾病治疗领域的成就，也彰显了集团在生物药物开发领域的能力，并显示出集团强大的自主研发能力。
系统性红斑狼疮(SLE)是自身免疫性风湿疾病中死亡率及致残率最高的疾病之一。根据弗若斯特沙利文的资料，2019年全球SLE患病人口约为7.7百万人，估计到2030年将达到860万人。在中国，2019年SLE患者约为100万人，估计到2030年将增至约110万人。根据弗若斯特沙利文的资料，估计全球SLE生物疗法的市场规模将按复合年增长率26.8%由2019年的8亿美元增至2030年的108亿美元。泰它西普是近60年内在中国获批的第二个可用于SLE的全新生物制剂。
据悉，泰它西普(RC18，商品名：泰爱)是公司专有用于治疗自身免疫性疾病的新型融合蛋白，由人跨膜激活剂及钙调亲环素配体相互作用因子(TACI)受体的胞外域以及人免疫球蛋白G(IgG)的可结晶片段(Fc)域构成。泰它西普靶向两类对B淋巴细胞发育至关重要的细胞信号分子：B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)，得以有效降低B细胞介导的自身免疫应答，自身免疫应答与多种自身免疫性疾病有关。公司现正于多种适应症开展II期或III期临床试验，评估泰它西普，以探索其治疗各种自身免疫性疾病的潜力，旨在解决该治疗领域中大量未满足或未充分满足的医疗需求。公司现正于后期临床试验评估泰它西普，以探索其解决七大自身免疫性疾病的潜力，旨在解决该治疗领域中大量未满足或未充分满足的医疗需求。
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