1.来那替尼片（neratinib），进口化药上市申请在2018年9月29日获得CDE受理公示。
2.CANbridge （北海康成）has licensed the exclusive rights to develop and commercialize NERLYNX (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China) from Puma Biotechnology, Inc. (Nasdaq: PBYI).
3.在美国批准的适应症：
NERLYNX® (neratinib) is a once-daily oral medicine for women who have just finished trastuzumab therapy (i.e., Herceptin®) following surgery for early-stage breast cancer.
NERLYNX is the first HER-2 targeted treatment approved by the FDA to further reduce the risk of recurrence after Herceptin. （早期、HER2阳性、术后曲妥珠单抗治疗，给存在高危风险的乳腺癌患者的强化治疗提供新的选择）
4.药物开发历史：
Neratinib was discovered and initially developed by Wyeth; Pfizer continued development up to Phase III in breast cancer, and licensed it to Puma Biotechnology in 2011.（惠氏开发，后期转给彪马生技）
In July 2017 it was approved by the US FDA for adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, (after adjuvant trastuzumab-based therapy).（美国批）
In January 2018 an EMA committee gave a negative review to neratinib.（欧盟拒）
5.看看我国CDE如何评定这款肿瘤药物的受益和风险。直接利用海外临床数据，加速审评应该仅限于真的临床学需要的产品！
参考：
https://nerlynx.com/about-nerlynx；
http://www.canbridgepharma.com/index/productdetail/5；
https://www.drugbank.ca/drugs/DB11828；
https://en.wikipedia.org/wiki/Neratinib；
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf；
https://endpts.com/puma-shares-tank-after-chmp-looks-ready-to-hit-a-red-light-on-neratinib/；
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