By Fineline Cube 
China-based Hefei Lifeon Pharmaceutical Co., Ltd (SHE: 003020) announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its generic version of Esperion Therapeutics’ Nexletol (bempedoic acid). The drug, an adenosine triphosphate-citrate lyase (ACL) inhibitor, will be evaluated in two key scenarios: as an adjunctive therapy with existing LDL-C lowering regimens and as a monotherapy for patients intolerant to statins.
Clinical Trial Details
The Phase III trial (CTR2024XXXX) will enroll patients with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH). This study aims to assess the safety and efficacy of Nexletol in these patient populations, providing valuable data for its potential use in China.
Market Context
Nexletol, approved in the US in 2020, is not yet available in China. However, Huayi Pharma and Gan & Lee Pharma are currently investigating their own generic versions in clinical trials. Lifeon’s approval marks a significant step toward bringing this innovative therapy to the Chinese market.-Fineline Info & Tech