China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs.
Nintedanib’s Approval History and Indications
Nintedanib was first approved in the US in 2014 and was subsequently approved in China in September 2017 for the treatment of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-related interstitial lung disease (SSc ILD). The drug has been included in the National Reimbursement Drug List (NRDL) for both indications following price negotiations in December 2020. According to China’s Orange Book, the drug’s two compound patents expired in October 2020.
Market Competition for Generic Nintedanib
Previously, CSPC, Kelun Pharma, and Qilu Pharma have all earned market approvals for their respective generic versions of nintedanib. The addition of Hansoh Pharmaceutical’s generic version to the market is expected to increase competition, potentially leading to more affordable options for patients in need of these treatments.-Fineline Info & Tech
