Who is the manufacturer of neratinib maleate/neratinib tablets?

Neratinib/Neratinib tablets are an important anti-cancer drug, mainly used to treat HER2-positive breast cancer. The original drug of neratinib is marketed in China as neratinib maleic acid tablets, with the trade name He Li'an. This drug is an oral irreversible tyrosine kinase inhibitor (TKI) of human epidermal growth factor receptor HER1 (EGFR), HER2 and HER4. It achieves anti-cancer effects by blocking the signal pathway transduction of these receptors.

Regarding the manufacturer of neratinib, it was originally developed by Wyeth (now Pfizer). However, with the continuous development and cooperation in the field of drug research and development, the subsequent research and development and production of neratinib were transferred to Puma Biotechnology. This company focuses on developing innovative cancer treatment drugs, and neratinib is one of its research and development results. Puma Biotechnology strictly follows international drug production standards during the development and production of neratinib to ensure the quality and safety of the drug. The company has advanced R&D facilities and production lines, as well as a professional R&D team and production personnel, which provide strong guarantee for the R&D and production of neratinib.

In general, neratinib tablets are developed and produced by Puma Biotechnology. After marketing, it can be suitable for long-term adjuvant treatment of adults with early-stage hormone receptor-positive HER2 overexpression/amplification breast cancer and adults who have completed trastuzumab-based early adjuvant treatment less than one year ago. In the United States, it is also indicated in combination with capecitabine for the treatment of adults with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.