CSPC PHARMA (01093) gained nearly 3% in late trading, closing up 2.04% at HK$7.51 with a turnover of HK$408 million. On December 15, the China National Medical Products Administration's Center for Drug Evaluation (CDE) accepted the clinical application for bempedoic acid tablets submitted by CSPC's wholly-owned subsidiary, CSPC Ou Yi Pharmaceutical Co., Ltd., under chemical drug registration category 3.
Bempedoic acid is an ATP-citrate lyase inhibitor primarily used to lower low-density lipoprotein cholesterol (LDL-C) in adult patients intolerant to statin therapy, reducing risks of myocardial infarction and coronary revascularization. The drug was first approved by the U.S. FDA in 2020. Market analysts project bempedoic acid tablets could capture up to a quarter of the cholesterol drug market, with peak sales potentially reaching $2-3 billion.
Notably, neither the original nor generic versions of bempedoic acid tablets are currently marketed in China. So far, four pharmaceutical companies—including CSPC Ou Yi Pharmaceutical, Gan & Lee Pharmaceuticals Shandong Co., Ltd., Jiangxi Shimei Pharmaceutical, and Hefei Lifon Pharmaceutical—have had their clinical applications for bempedoic acid tablets accepted, marking the start of competition for first generic approval.
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