China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of eplerenone, an aldosterone receptor antagonist. The drug, co-developed with Nanjing Cavendish Bioengineering Technology Co., Ltd., is indicated for the treatment of hypertension.
Eplerenone: A Second-Generation Mineralocorticoid Receptor Antagonist (MRA)
The originator drug, developed by Pharmacia & Upjohn (later acquired by Pfizer), was first approved in the US in 2002 and has not yet entered the Chinese market. Prior to this approval, spironolactone was the sole mineralocorticoid receptor antagonist (MRA) drug available in China. As a first-generation MRA product, spironolactone is often associated with side effects such as male breast development, female amenorrhea, and postmenopausal bleeding due to its low selectivity to the mineralocorticoid receptor (MR).
Advantages of Eplerenone Over First-Generation MRAs
Eplerenone, a second-generation MRA, offers higher selectivity for the MR and lower affinity to androgen and progestogen receptors, resulting in fewer side effects. This new generic version from Grand Pharmaceutical Group is expected to provide a more effective and safer alternative for hypertension patients in China, potentially improving treatment outcomes and patient compliance.-Fineline Info & Tech
