Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its neratinib maleate active pharmaceutical ingredient (API) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the company’s efforts to bring this important drug to the Chinese market.
Drug Background and Development
Neratinib maleate is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) originally developed by US giant Pfizer. The drug was licensed to Puma Biotechnology, Inc. in July 2011. CANbridge Pharmaceuticals secured development and commercial rights to neratinib in Greater China in a January 2018 deal with Puma. The drug was first approved in the US in 2017 as an extended adjuvant therapy for patients with early Her2 breast cancer. It also received market approval in China in April 2020 for use as intensive adjuvant therapy for Her2-positive early breast cancer after adjuvant therapy containing trastuzumab.
Market Performance
Neratinib maleate has demonstrated strong market performance, generating USD 190 million in global sales in 2021. The acceptance of the market filing by the NMPA underscores the potential demand for this drug in China, where breast cancer remains a significant health concern.
Future Outlook
The review process by the NMPA highlights Aosaikang Pharmaceutical’s commitment to expanding its product portfolio and addressing unmet medical needs in oncology. With neratinib maleate’s proven efficacy and safety profile, Aosaikang aims to enhance treatment options for patients with Her2-positive breast cancer.-Fineline Info & Tech
