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[求助]
求助來那替尼上市信息？ 已有1人參與
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| 在網(wǎng)上看到有公司掛來那替尼項目合作信息，在CDE上有來那替尼片的進口申請，但是我卻查不到該藥的具體上市信息，特此求助，望大俠相幫，謝謝！ |
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酔欲陶然
木蟲 (正式寫手)
- 應助: 7 (幼兒園)
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- 專業(yè): 合成藥物化學
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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 |
5樓2014-08-28 09:04:03
6樓2014-08-28 09:30:07
9樓2014-08-28 14:11:11
2樓2014-08-27 16:55:56
3樓2014-08-27 16:58:18
4樓2014-08-28 08:46:35
7樓2014-08-28 11:20:00
8樓2014-08-28 11:22:08
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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樓2014-08-28 18:00:06
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