China-based Kexing Pharmaceutical (SHA: 688136) has announced a licensing agreement with compatriot firm Convalife, securing commercial rights to the latter’s generic version of Puma Biotechnology Inc’s neratinib in six countries outside China. This move expands access to the oral irreversible small molecule pan-HER tyrosine kinase inhibitor (TKI) for patients in these regions.
Neratinib’s Mechanism of Action and Global Approvals
Neratinib is an oral irreversible small molecule pan-HER TKI that irreversibly blocks the downstream signaling pathways of HER2 and ER, inhibiting tumor cell proliferation and growth. The originator drug received market approval in the US in July 2017 for intensive adjuvant therapy for HER2-positive early breast cancer following trastuzumab as adjuvant therapy. It later gained approval in Europe in September 2018 and was approved in China in April 2020, entering the national reimbursement drug list (NRDL) in 2021. Neratinib is also under development to treat non-small cell lung cancer, cervical cancer, biliary system tumors, and salivary gland tumors.
Convalife’s Licensing Deal with Fosun Pharma
In December 2021, Convalife struck a licensing deal with Jiangsu Fosun Pharma Sales Co., Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), granting the subsidiary exclusive commercialization rights to the drug in Greater China. This agreement, along with the one with Kexing Pharmaceutical, highlights the strategic expansion of neratinib’s market reach in key regions.-Fineline Info & Tech
