国内首个CDK4/6抑制剂哌柏西利上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-03-31 11:18
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(Summary description)乳腺癌是发生在乳腺上皮组织的恶性肿瘤，是严重威胁全世界女性健康的第一大恶性肿瘤，我国虽不是乳腺癌的高发国家，但近年乳腺癌发病率正以每年3%～4%的增长率急剧上升，每年新发10个患者就有1个被确诊为晚期，晚期乳腺癌患者的中位生存期仅有2-3年，5年生存率仅约20%，在接受过手术及规范治疗的早期乳腺癌患者中也有30-40%会发展为晚期乳腺癌，晚期乳腺癌患者迫切需要创新的治疗方案。2013年美国食品与药

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国内首个CDK4/6抑制剂哌柏西利上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-03-31 11:18
Views:

Information

乳腺癌是发生在乳腺上皮组织的恶性肿瘤，是严重威胁全世界女性健康的第一大恶性肿瘤，我国虽不是乳腺癌的高发国家，但近年乳腺癌发病率正以每年3%～4%的增长率急剧上升，每年新发10个患者就有1个被确诊为晚期，晚期乳腺癌患者的中位生存期仅有2-3年，5年生存率仅约20%，在接受过手术及规范治疗的早期乳腺癌患者中也有30-40%会发展为晚期乳腺癌，晚期乳腺癌患者迫切需要创新的治疗方案。

2013年美国食品与药品管理局（FDA）核准全球首个细胞周期蛋白依赖性激酶（CDK）4/6抑制剂爱博新® IBRANCE®（哌柏西利, Palbociclib）为治疗晚期乳腺癌的突破性新药，2015年FDA以快速审批程序批准爱博新®上市，用于治疗晚期乳腺癌。2018年7月31日，爱博新®获得中国国家药品监督管理局（CFDA）批准，可用于激素受体阳性（HR+）和人表皮生长因子受体2阴性（HER2-）的乳腺癌治疗。

CDK4/6抑制剂

周期蛋白依赖性激酶4/6（cyclin-dependent kinase4/6,CDK4/6)是一类丝/苏氨酸激酶，与细胞周期素D（cyclinD）结合调节细胞由G1期向S期转换。在很多肿瘤中，都存在“cyclinD-CDK4/6-INK4-Rb通路”异常，这条通路的改变加速了G1期进程，使得肿瘤细胞增殖加快进而增殖失控，因此目前认为，CDK4/6抑制剂能够选择性抑制CDK4/6，恢复细胞周期控制，从而阻断肿瘤细胞增殖。对cyclinD-CDK4/6-INK4-Rb通路的干预成为一种治疗策略，CDK4/6也因此成为近几年抗肿瘤的热门靶点之一。

目前FDA总共批准了三个CDK4/6抑制剂药物，分别是：辉瑞的Palbociclib（哌柏西利，商品名Ibrance）、诺华的Ribociclib（商品名Kisqali）和礼来的Abemaciclib（商品名Verzenio），其中后两款药物还未在国内上市。研究数据显示，无论是一线或二线、绝经前或绝经后，三个CDK4/6抑制剂均可显著提高客观有效率、延长患者的无进展生存期（PFS），尤其是在一线治疗中，三个CDK4/6抑制剂均可延长PFS 10个月以上。

药物简介

中文名：哌柏西利

英文名：Palbociclib

商品名：爱博新®（IBRANCE®）

分子式：C₂₄H₂₉N₇O₂

哌柏西利是辉瑞（Pfizer Inc.）研发的CDK4/6抑制剂药物，适用于治疗HR+/HER2-局部晚期或转移性乳腺癌，与芳香化酶抑制剂联合使用作为绝经后女性患者的初始内分泌治疗。

专利信息

哌柏西利在美国橙皮书中共登记有3篇相关的美国专利，有3篇中国同族专利，所有专利皆已授权。

公开号	专利名称	申请日	法律状态
US6936612	2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones	2003-01-16	授权
US7208489	2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones	2005-01-28	授权
US7456168	2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones	2007-04-11	授权
CN101906104B	2-(吡啶-2-基氨基)-吡啶并[2,3-d]嘧啶-7-酮	2003-01-10	授权
CN101001857B	2-(吡啶-2-基氨基)-吡啶并[2,3-d]嘧啶-7-酮	2003-01-10	授权
CN102295643B	2-(吡啶-2-基氨基)-吡啶并[2,3-d]嘧啶-7-酮	2003-01-10	授权

国内药企布局情形

根据中国新药研发监测数据库（CPM）显示，除了齐鲁制药申报仿制药上市外，目前还有豪森、恒瑞、海正、正大天晴等十多家在研企业在进行临床试验，虎视眈眈地瞄准超过30亿美元的市场大饼。

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Electronic Arts pledges free use for five accessibility patents

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