Gan & Lee Becomes First to File NDA for Bempedoic Acid Tablets in China

Gan & Lee Pharmaceuticals has become the first company to file a new drug application for bempedoic acid tablets in China, breaking new ground in the country's lipid-lowering drug market where no version of the medication has yet been approved or marketed domestically.

The filing, submitted on May 14, marks a significant milestone for the Chinese pharmaceutical company, which completed its Phase 3 clinical trial for the drug in February. The move positions Gan & Lee as the frontrunner in what could become a competitive race for the first generic version of bempedoic acid in the Chinese market.

Bempedoic acid, originally developed by U.S. biopharmaceutical company Esperion Therapeutics, holds a distinctive place in cardiovascular medicine. When the U.S. Food and Drug Administration first approved the drug on February 21, 2020, it became the first oral non-statin cholesterol-lowering therapy to win regulatory approval in roughly two decades. The medication offers a complementary treatment option for patients who cannot tolerate statins or who fail to achieve adequate lipid control with statin therapy alone.

The drug launched in the United States in two formulations: bempedoic acid as a standalone product and a combination tablet pairing bempedoic acid with ezetimibe, another cholesterol-lowering agent. However, neither version has been introduced to the Chinese market, and the original developer has signaled no plans to seek domestic approval, leaving the field open entirely for generic competition.

The commercial opportunity extends well beyond China's borders. In 2020, Japan's Daiichi Sankyo, through its European subsidiary, secured an exclusive licensing agreement with Esperion to market both the standalone and combination bempedoic acid products across the European Economic Area and Switzerland. According to Daiichi Sankyo's financial disclosures, bempedoic acid and its combination products generated combined European sales of 36.9 billion yen, approximately 1.554 billion Chinese yuan, in 2024, with growth continuing at a rapid pace. Esperion has not yet disclosed its U.S. sales figures.

Back in China, the competitive landscape for bempedoic acid generics is taking shape. Jiangxi Shimei Pharmaceutical Co., Ltd. obtained clinical trial approval for the standalone bempedoic acid tablet more than a year ago, but progress has been slow. The company has completed only a bioequivalence study and has yet to advance to Phase 3 trials. CSPC Pharmaceutical Group Limited and Hefei Lifang Pharmaceutical are currently recruiting patients for their respective Phase 3 studies.

The regulatory environment recently shifted with the May 15 implementation of China's Drug Trial Data Protection Implementation Measures. Under the new rules, the first company to successfully file a generic for a Class 3 drug may be granted a data protection period, while subsequent applicants can be exempted from confirmatory clinical trials. This framework adds strategic urgency to the race, though it remains to be seen whether CSPC and Hefei Lifang will continue their costly Phase 3 programs in light of Gan & Lee's head start.

Meanwhile, a separate development underscores the intensity of competition in China's lipid-lowering market. On June 17, Nanjing Zhengke Pharmaceutical filed for a clinical trial of a bempedoic acid/ezetimibe combination tablet, a Class 3 combination lipid-lowering drug. Shimei Pharmaceutical had already secured clinical approval for this combination product in 2025, but its slow progress has opened the door for rivals. Notably, neither Gan & Lee nor CSPC has pursued the combination formulation, despite clinical evidence suggesting that pairing bempedoic acid with ezetimibe produces stronger lipid-lowering effects.

The bempedoic acid story runs parallel to another hotly contested lipid-lowering drug: pemafibrate. Both medications target patients who cannot tolerate statins, both are oral therapies, and both face patent expiration in their original markets. But their development trajectories differ in important ways. Pemafibrate, developed by Japan's Kowa Company, received import approval in China on April 8, 2025. Within just nine days of the original product's domestic launch, Chia Tai Tianqing submitted a generic application, setting a record for the shortest gap between originator approval and generic filing. Nearly 30 companies have since followed suit in less than a year.

Yet pemafibrate's generic race has been marked by setbacks. Multiple applicants have received rejection notices, and a first generic approval has yet to materialize. By contrast, bempedoic acid's originator has no plans to enter the Chinese market, meaning generic developers will need to conduct their own Phase 3 trials, raising the barrier to entry but potentially resulting in a less crowded field.

The underlying market opportunity is substantial. Hyperlipidemia remains one of the most prevalent chronic conditions in China, with the domestic treatment market exceeding 20 billion Chinese yuan. Statins have long served as the cornerstone of lipid-lowering therapy, their efficacy and safety profile well established over decades. But statin-associated muscle toxicity, liver injury, and general intolerance affect a meaningful share of patients, creating sustained demand for alternative therapies.

Gan & Lee's first-mover advantage in bempedoic acid, combined with the drug's proven international commercial performance and China's vast untreated patient population, positions the company at the intersection of unmet medical need and significant market opportunity. Whether it can convert that position into a dominant market share before generic competitors arrive will determine the drug's trajectory in the world's second-largest pharmaceutical market.