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Lenatinib Maleate/neratinib Maleate API

Lenatinib Maleate/neratinib Maleate API

CAS:915942-22-2
Source:India
Qualifications:USDMF/-/-/-/-

Product Details

NameLenatinib maleate/neratinib maleate
Chinese name马来酸来那替尼/马来酸奈拉替尼
Cas Number915942-22-2
SourceIndia
QualificationsUSDMF/-/-/-/-



Lenatinib maleate was originally developed by Wyeth. After Wyeth was acquired by Pfizer, it was authorized to the U.S. PUMA Biotechnology Company to be responsible for R&D, listing, production and sales. It was approved by the U.S. Food and Drug Administration on July 17, 2017. FDA) approved for marketing and is the first and only small molecule drug used for intensive adjuvant therapy of HER2-positive early breast cancer. The original research was approved for listing in China in 2020. Lenatinib maleate is a kinase inhibitor that can irreversibly bind to epidermal growth factor receptor (EGFR), HER2 and HER4. In vitro, lenatinib maleate reduces autophosphorylation of EGFR and HER2, MAPK and AKT downstream signaling pathways, and shows anti-tumor activity in tumor cell lines expressing EGFR and/or HER2. The clinical data at a median follow-up of 5.2 years showed that compared with the placebo group, the risk of recurrence or death of invasive disease in the lenatinib treatment group was significantly reduced by 34%. After completing trastuzumab-containing therapy, neratinib was used for one year. Global follow-up data showed that the two-year and five-year noninvasive tumor recurrence survival (iDFS) were better than trastuzumab alone. In 2019, lenatinib maleate sales were US$212 million.




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