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Tina_1988

铜虫 (初入文坛)

[求助] 求助来那替尼上市信息?已有1人参与

在网上看到有公司挂来那替尼项目合作信息,在CDE上有来那替尼片的进口申请,但是我却查不到该药的具体上市信息,特此求助,望大侠相帮,谢谢!
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酔欲陶然

木虫 (正式写手)

Puma Biotechnology, under license from Pfizer (previously Wyeth), is developing neratinib (PB-272; HKI-272), an irreversible pan-HER (Erbb1, ErbB2 and ErbB4) tyrosine kinase inhibitor, for the potential oral treatment of HER2-positive cancers, primarily breast cancer
    In July 2009, worldwide phase III breast cancer trials were initiated by Wyeth in patients who had received prior trastuzumab-based therapy ; in October 2011, following its acquisition of rights, Puma intended to terminate the ongoing Pfizer-sponsored trials , and the company began its own phase III trial in third-line metastatic breast cancer in June 2013 . In July 2014, Puma planned to file the drug for approval in the extended adjuvant setting for breast cancer in 1H15 .

Development in other HER2-positive cancer settings is ongoing. In April 2013, a phase II trial in patients with NSCLC was ongoing . In October 2013, a phase II study in patients with other solid tumors with a HER2 mutation was initiated ; in March 2014, initial data from the trial were expected in 2014
共君一醉一陶
5楼2014-08-28 09:04:03
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fepwjh7

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还没有在国内外上市,不排除最后被毙掉的可能。你看看汤姆数据报告
6楼2014-08-28 09:30:07
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kdl0721

金虫 (著名写手)

引用回帖:
8楼: Originally posted by Tina_1988 at 2014-08-28 11:22:08
我查到信息该药也是在刚做完3期,预计明年才开始申报。但是CDE上怎么有来那替尼片的进口申请呢(截图未成功,但确实有该申请)?搞不清楚了…...

国内申报进口跟申请FDA和EMA上市并没有联系。nintedanib同样也是申请进口临床,而nintedanib也没有在FDA上市,只是被FDA授予突破性疗法。
9楼2014-08-28 14:11:11
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kdl0721

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【答案】应助回帖

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感谢参与,应助指数 +1
Tina_1988: 金币+5, 谢谢回复 2014-08-28 11:30:26
现在应该是正在申请进口临床吧,等进口还得需要2-3年吧。
2楼2014-08-27 16:55:56
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Tina_1988

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引用回帖:
2楼: Originally posted by kdl0721 at 2014-08-27 16:55:56
现在应该是正在申请进口临床吧,等进口还得需要2-3年吧。

你好,谢谢回复。我想查该药在国外的上市信息,一直没找到,……
3楼2014-08-27 16:58:18
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kdl0721

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引用回帖:
3楼: Originally posted by Tina_1988 at 2014-08-27 16:58:18
你好,谢谢回复。我想查该药在国外的上市信息,一直没找到,……...

来那替尼(neratinib)刚获做完Ⅲ期临床试验(ExteNET),现在还没上市。
4楼2014-08-28 08:46:35
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Tina_1988

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我查到信息该药也是在刚做完3期,预计明年才开始申报。但是CDE上怎么有来那替尼片的进口申请呢?搞不清楚了……
7楼2014-08-28 11:20:00
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Tina_1988

铜虫 (初入文坛)

引用回帖:
4楼: Originally posted by kdl0721 at 2014-08-28 08:46:35
来那替尼(neratinib)刚获做完Ⅲ期临床试验(ExteNET),现在还没上市。...

我查到信息该药也是在刚做完3期,预计明年才开始申报。但是CDE上怎么有来那替尼片的进口申请呢(截图未成功,但确实有该申请)?搞不清楚了…
8楼2014-08-28 11:22:08
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fishlone

金虫 (著名写手)

Puma Biotechnology, under license from Pfizer (previously Wyeth), is developing neratinib (PB-272; HKI-272), an irreversible pan-HER (Erbb1, ErbB2 and ErbB4) tyrosine kinase inhibitor, for the potential oral treatment of HER2-positive cancers, primarily breast cancer
    In July 2009, worldwide phase III breast cancer trials were initiated by Wyeth in patients who had received prior trastuzumab-based therapy ; in October 2011, following its acquisition of rights, Puma intended to terminate the ongoing Pfizer-sponsored trials , and the company began its own phase III trial in third-line metastatic breast cancer in June 2013 . In July 2014, Puma planned to file the drug for approval in the extended adjuvant setting for breast cancer in 1H15 .

Development in other HER2-positive cancer settings is ongoing. In April 2013, a phase II trial in patients with NSCLC was ongoing . In October 2013, a phase II study in patients with other solid tumors with a HER2 mutation was initiated ; in March 2014, initial data from the trial were expected in 2014
10楼2014-08-28 18:00:06
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