Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S’s version, an in-house developed crystal form of the molecule, has passed China’s bioequivalence (BE) clinical testing. The approval is notable as it is the first generic to be approved in China and the first to successfully challenge Entresto globally.
Entresto’s Market Impact and Sales in China
Entresto, recognized as a breakthrough therapy for chronic heart failure, was first approved in China in 2017 and later for primary hypertension in June 2021. The drug has been a significant revenue generator, with close to RMB 3 billion (USD 415 million) in sales in China last year.
Patent Landscape and Generic Market Entry
The Orange Book lists six patents related to the drug registered in China, all focusing on “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). Despite one of these patents being declared invalid in April 2017, and this decision being reconfirmed by the China National Intellectual Property Administration (CNIPA) in 2018 and by the People’s Court in 2019, it was not sufficient to pave the way for generic market entry. In 2021, CNIPA confirmed that the drug’s core patent remained valid, with the 20-year patent protection period for both of Entresto’s core patents set to expire on November 8, 2026. The approval of F&S Pharma’s generic version is a game-changer, allowing Chinese patients with heart failure and hypertension to access a high-quality copy drug three years ahead of the patent expiration.-Fineline Info & Tech
