China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has obtained another indication approval in China for its generic version of BI/Eli Lilly’s Jardiance (empagliflozin). The hypoglycemic agent can now be used to reduce the risk of hospitalization due to heart failure in adult patients with symptomatic chronic heart failure.
Jardiance: Background and Approvals
Jardiance, a sodium-dependent glucose transporters 2 (SGLT-2) inhibitor, was approved in the European Union in 2014, followed by the US and Japan. It was approved in China in September 2017 for use in improving blood glucose control in patients with type 2 diabetes. The drug saw its price cut by 56.5% for entry into the National Reimbursement Drug List (NRDL) in November 2019. Hansoh Pharma’s first generic version was approved in July 2020 in China, and Kelun Pharma’s version received approval one month later. Jardiance was involved in the fourth volume-based procurement (VBP) in 2021 and was approved to treat adult heart failure patients with or without diabetes and low ejection fraction in June last year.
Kelun Pharma’s Generic and NRDL Inclusion
Kelun Pharma’s generic version of Jardiance has passed the generic quality consistency evaluation and is included in the national centralized procurement list. With the implementation of the 2022 NRDL as of March 1 this year, and the expanded use of empagliflozin, patients with chronic heart failure can now enjoy medical insurance reimbursement policies to lower their medication burden.-Fineline Info & Tech
