By Fineline Cube Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare mutations in EGFR, an indication that has not yet been approved anywhere globally.
Overseas and Greater China Rights Held by Kexing Pharmaceutical and Fosun Pharmaceutical
Kexing Pharmaceutical (SHA: 688136) possesses the overseas commercialization rights to the drug, while Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) holds the rights in Greater China. Research results from the pharmaceutical study indicate that the production process of neratinib is stable, exhibiting a good stability profile. Non-clinical studies have shown that it demonstrates promising activity against advanced NSCLC with rare EGFR mutations.
Neratinib’s Global Regulatory and Market Progress
The originator drug obtained market approval in the US in July 2017 as intensive adjuvant therapy for HER2-positive early breast cancer following trastuzumab adjuvant therapy. It later gained approval in Europe in September 2018. In China, the drug was approved in April 2020 and has since been included in the national reimbursement drug list (NRDL) in 2021.-Fineline Info & Tech