China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Swiss giant Novartis’s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan), has been approved for marketing in China. This approval comes on the same day as its compatriot firm Nanjing F&S Pharmatech Co., Ltd secured the first-mover advantage with its version of the drug. The product is now approved for use in treating adult patients with chronic heart failure (NYHA II-IV grade, LVEF ≤ 40%) with reduced ejection fraction, aiming to reduce the risk of cardiovascular death and hospitalization for heart failure and primary hypertension.
Entresto’s Market Performance and Patent Status
Entresto, a breakthrough therapy for chronic heart failure, was first approved in China in 2017 and later for primary hypertension in June 2021. The drug generated close to RMB 3 billion (USD 415 million) in sales in China last year, highlighting its significance in the treatment of heart failure.
Patent Protection and Generic Market Entry
The Orange Book indicates that there are six patents relating to the drug registered in China, all concerning “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). The patent was declared invalid in April 2017, a decision later reconfirmed by CNIPA in 2018 and confirmed by the People’s Court in 2019. However, this was not sufficient to allow generics onto the market. 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.-Fineline Info & Tech
