注射用盐酸美法仑（Evomela®）在中国获批

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-01-25 13:22
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(Summary description)2018年12月3日，CASI宣布Evomela®（优维宁，注射用盐酸美法仑）在中国获得批准，用于多发性骨髓瘤患者进行自体干细胞移植前高剂量治疗，或不适宜于美法仑口服制剂多发性骨髓瘤患者的姑息治疗。这是CASI首个独立通过审批的药物，在此之前都是通过合作伙伴申请。此药也是中国国家医疗产品管理局首次通过国外临床数据进入新优先审评获得批准的罕见病药物之一，究其原因有三：（1）与现有治疗手段相比具有明显

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注射用盐酸美法仑（Evomela®）在中国获批

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-01-25 13:22
Views:

Information

2018年12月3日，CASI宣布Evomela®（优维宁，注射用盐酸美法仑）在中国获得批准，用于多发性骨髓瘤患者进行自体干细胞移植前高剂量治疗，或不适宜于美法仑口服制剂多发性骨髓瘤患者的姑息治疗。

这是CASI首个独立通过审批的药物，在此之前都是通过合作伙伴申请。此药也是中国国家医疗产品管理局首次通过国外临床数据进入新优先审评获得批准的罕见病药物之一，究其原因有三：（1）与现有治疗手段相比具有明显治疗优势创新药；（2）用于治疗我国罕见病多发性骨髓瘤；（3）临床短缺。

该药属于注册分类5.1类。2016年12月，CFDA通过Evolmela进口注册批准，同年4月进入审评，9月进入优先审评通道，12月在中国获得上市批准，从进入审批程序到正式获得批准，一共花了242天。

多发性骨髓瘤

多发性骨髓瘤(multiple myeloma, MM)是一种由骨髓浆细胞异常增生引发的系统性恶性肿瘤，肿瘤在骨髓内积聚，多伴有单克隆抗体分泌，导致骨髓衰竭及骨质破坏。由于起病徐缓，可有数月至十多年无症状期，早期易被误诊，目前无法根治，仍以抗肿瘤化疗为主，尽管多发性骨髓瘤通常对细胞毒药物化疗敏感，但大多数病人反应时间短且经常复发。美法仑是接受自体干细胞移植的多发性骨髓瘤患者最常用的大剂量预处理静脉注射药物。

此病多发于老年人，可导致骨髓衰竭、骨质破坏、高钙血症、贫血、感染、肾衰竭和神经系统等症状。目前，中国多发性骨髓瘤发病率约为十万分之一，成为仅次于非霍奇金淋巴瘤的第二大血液系统恶性肿瘤，相对于西方国家十万分之3.6~6.3的发病率来说还是比较罕见，但随着社会逐渐步入老龄化，老年人口基数不断增长，多发性骨髓瘤的疾病负担还会加大。

药物简介

中文名：盐酸美法仑

英文名：Melphalan Hydrochloride

商品名：优维宁（Evomela®）

分子式：C₁₃H₁₈Cl₂N₂O₂﹒HCl

Evomela®是一种使用Captisol技术（由Ligand Pharmaceuticals 开发）的非丙二醇的新型静脉制剂，该药物已被FDA授予孤儿药并批准上市。在现有盐酸美法仑注射液中，丙二醇作为增溶剂使用，有报道称丙二醇可引起肾脏和心脏方面的不良反应，因此限制了美法仑注射液的大剂量应用。

Captisol技术提高美法仑的溶解性及稳定性，不再需要含有丙二醇的助溶剂，并且，研究数据肯定了新剂型作为多发性骨髓瘤患者自体干细胞移植过程中大剂量预处理方案用药的疗效及可接受的安全性，使临床医生实现移植前安全地使用较高剂量的化疗成为可能，同时，这也是继1964年美法仑获批后的首个新型制剂。

关于Captisol技术

Captisol是一项受专利保护的改良环糊精类药物，其结构使得药物具有良好的溶解性及稳定性，最初是由堪萨斯Higuchi生物科学中心Valentino Stella博士的实验室为取得药物研发及配制的特定效果而开发的。这一独特的技术促进了6种药物通过FDA审批，包括Onyx药业的Kyprolis、百特国际的Nexterone和默克公司的NOXAFIL IV。除此之外，还有30余项利用了Captisol技术的产品处于临床研发阶段。

专利信息

Evomela®在美国橙皮书中共登记有4篇相关的美国专利，均有中国同族专利，其中两篇中国同族还在实质审查中。

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Electronic Arts pledges free use for five accessibility patents

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