先声药业「艾拉莫德片」治疗原发性干燥综合征临床申请获批

2020-09-10 医药魔方 医药魔方

9月8日,先声药业研发的抗风湿新药艾拉莫德片(商品名:艾得辛?)用于治疗原发性干燥综合征(pSS)的新药临床试验申请(受理号CXHL2000340/1/2)获得批准。艾拉莫德片于2011年在全球率先上

9月8日,先声药业研发的抗风湿新药艾拉莫德片(商品名:艾得辛?)用于治疗原发性干燥综合征(pSS)的新药临床试验申请(受理号CXHL2000340/1/2)获得批准。艾拉莫德片于2011年在全球率先上市,是我国具有完全自主知识产权的首个1.1类抗风湿新药,丰富了类风湿关节炎小分子治疗药物的选择。

此次临床申请获批,艾得辛(艾拉莫德片)有望成为国内首个用于治疗原发性干燥综合征的药物,这是继获批治疗类风湿关节炎后拓展的第一个新适应症。原发性干燥综合征是系统性红斑狼疮、类风湿关节炎之外的又一慢性、系统性、自身免疫性疾病。该疾病主要特征为外分泌腺受累,常见临床表现为口干、眼干、疲劳和关节痛等症状,这三种症状见于80%以上患者,极大影响患者的生活质量。pSS以中年女性患者为多,总患病率约为61/10万,我国人群总患病率约0.29%-0.77%,预计总人数大约400-1000万。干燥综合征临床表征相比于其他自身免疫性疾病,pSS的治疗尚未取得显着进展,目前没有基于高质量等级证据的治疗指南,也缺少治疗pSS的经典评价标准。

目前,全球尚没有药物获得pSS的适应症,pSS的治疗存在巨大的临床未满足的需求。由于 pSS 尚无满意的治疗措施,无论是干燥、疲乏、疼痛或内脏器官损害均缺乏经循证医学论证的有效药物,特别是用于控制并延缓系统损伤的药物,现使用的药物多为经验性治疗,或借鉴类似病变的治疗。临床上主要还是采用涎液和泪液的替代治疗以改善口干和眼干症状,使用非甾体抗炎镇痛药减轻肌肉、关节痛等,这些对症治疗可以一定程度上缓解患者症状,但是不能真正缓解疾病进程,且对于其他重要脏器受累的患者疗效不佳。pSS的发病机制尚不清晰,目前而言,全球有20多种化学药物和生物制剂正处在pSS治疗的研发进程中。尽管治疗pSS的研发层出不穷,但是缺乏特异性治疗的药物,且大多进展缓慢(暂无进入III期临床试验阶段的药物),快速推进pSS治疗高效药物的研发存在迫切的需求。新型DMARD艾拉莫德机制研究表明其能够通过调节蛋白激酶C/早期生长反应因子1(PKC/EGR1)途径抑制B细胞产生免疫球蛋白,同时还可抑制 IL-17和NF-κB信号通路,提示艾拉莫德具有治疗pSS的机制基础。

艾拉莫德治疗pSS部分已发表研究简介目前,艾拉莫德治疗pSS已逐步积累了多项临床数据,显示艾拉莫德能有效改善pSS患者疾病活动度及各项指标,且安全性良好,证实了艾拉莫德对pSS的治疗价值。在前期大量临床证据的基础上,艾拉莫德于今年4月已正式进入了我国《原发性干燥综合征诊疗规范》,并于今日正式获批原发性干燥综合征IND,有望成为第一个将原发性干燥综合征写入说明书的药物。2011年1.1类创新药艾得辛?(艾拉莫德片)的成功上市是先声药业创新发展的里程碑,开启了先声药业持续构筑研发管线、推出创新药的上升发展轨道。

多年来,先声药业聚焦源头转化创新,深耕创新药领域,在今年已上市了两款重磅创新药产品:分别是生物创新药恩瑞舒?(阿巴西普注射液)、1类创新药先必新?(依达拉奉右莰醇注射用浓溶液),预计2021年还将上市重磅药物PD-L1抑制剂KN035 (Envafolimab)。除这三个重磅药物外,先声药业在肿瘤疾病、中枢神经系统疾病、自身免疫疾病三大领域一共还有近50种不同研究阶段的创新药在研产品。在自身免疫疾病领域,除了已上市的艾得辛?(艾拉莫德片),恩瑞舒?(阿巴西普注射液),艾捷维?(枸橼酸托法替布片),英太青?(双氯芬酸钠胶囊/凝胶)之外,还有三款在研产品,产品布局日趋完善,已逐步成为自身免疫疾病领域的创新标杆,切实为自身免疫疾病患者带来更多精准、安全有效的药物。先声药业作为一家快速向创新驱动转型的制药公司,凭借领先的研发和商业化能力,致力于「让患者早日用上更有效药物」。相信此次艾得辛?(艾拉莫德片)治疗原发性干燥综合征IND获批,将会极大地推动此治疗领域的发展,为几百万患者带来福音。

参考文献

[1] Ye Y, Liu M, Tang L, et al. Iguratimod represses B cell terminaldifferentiation linked with the inhibition of PKC/EGR1 axis[J]. ArthritisResearch & Therapy, 2019, 21(1): 92.

[2] Luo Q, Sun Y, Liu W, et al. A Novel Disease-Modifying AntirheumaticDrug, Iguratimod, Ameliorates Murine Arthritis by Blocking IL-17 Signaling,Distinct from Methotrexate and Leflunomide[J]. The Journal of Immunology, 2013,191(10): 4969–4978.

[3] Aikawa Y, Yamamoto M, Yamamoto T, et al. An anti-rheumatic agentT-614 inhibits NF-kappaB activation in LPS- and TNF-alpha-stimulated THP-1cells without interfering with IkappaBalpha degradation[J]. Inflammationresearch : official journal of the European Histamine Research Society [et al], 2002,51(4):188-194.

[4] R. Felten, F. Scher, J. Siblia, et al,AutoimmunityReviews.2018.12.008

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    2021-07-06 悠然医者仁心666

    很赞!

    0

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