Chinese Domestic Lipid-Lowering Drug Gains FDA Approval for Additional Manufacturing Site, Accelerating Entry into U.S. Market

　　【Pharmaceutical Network Product Information】On October 26, it was reported that Lunan Pharmaceutical has received an approval letter from the U.S. FDA regarding the addition of a manufacturing site at Shandong New Time Pharmaceutical Co., Ltd. for the Abbreviated New Drug Application (ANDA) of Rosuvastatin Calcium Tablets. This approval will help increase the production capacity of Rosuvastatin Calcium Tablets, ensure a continuous and stable market supply, further meet U.S. market demand, and accelerate market penetration, while guaranteeing drug accessibility for patients. It also indirectly demonstrates that its product quality meets U.S. pharmaceutical and cGMP standards, highlighting the company's robust innovative capacity and rapidly advancing research and development strength.
 

Rosuvastatin Calcium Tablets is a selective hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that can effectively lower blood lipid levels, reverse atherosclerotic plaques, and improve inflammatory markers of atherosclerosis. Trial results indicate that rosuvastatin calcium increases the number of hepatic LDL receptors on the cell surface, thereby enhancing the uptake and catabolism of LDL, and inhibiting hepatic VLDL synthesis, ultimately reducing the total number of VLDL and LDL particles.
 

This drug is indicated for primary hypercholesterolemia (Type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (Type IIb) that is not adequately controlled by diet and other non-pharmacological treatments (e.g., exercise therapy, weight reduction); it is also indicated for patients with homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering measures (e.g., LDL apheresis), or when such methods are not applicable.
 

The originator drug of this product was developed by AstraZeneca in the UK and launched in the United States in 2003. Since 2010, global sales of the originator have consistently remained above US$5 billion, classifying it as a blockbuster lipid-lowering medication. In China, data from Menet indicates that terminal sales of rosuvastatin calcium tablets in public medical institutions reached RMB 4.206 billion in 2016, increased to RMB 5.02 billion in 2017, and reached RMB 6.854 billion in 2018, demonstrating an overall year-on-year growth trend.
 

It is worth noting that rosuvastatin calcium tablets have also been selected in the national centralized procurement program. Currently, rosuvastatin calcium tablets are listed in Category B of the 2019 National Reimbursement Drug List and the 2018 National Essential Medicines List, accounting for over 22% of the domestic market share for lipid-lowering drugs.
 

It is recognized that cholesterol levels vary among ethnic groups, and serious adverse reactions associated with statins are significantly positively correlated with dosage; specifically, higher doses result in a greater incidence of adverse reactions. Departing from conventional originator drug paradigms and overcoming numerous challenges, Lunan Pharmaceutical spent a decade developing the 5 mg strength of Rosuvastatin Calcium Tablets (trade name: Ruizhi®), which delivers potent, rapid, and safe lipid-lowering efficacy. Approved for marketing by China’s NMPA in 2008, this formulation is better optimized for the Chinese population, effectively reducing treatment costs for patients while facilitating dose adjustments.
 

To further advance the company's internationalization process, Lunan Pharmaceutical has been submitting ANDA applications since 2011. The successful ANDA approval for Rosuvastatin Calcium Tablets in May 2018 will actively drive the company's expansion into the international finished dosage form market, marking a historic milestone for Lunan Pharmaceutical toward achieving its grand vision of a "Healthy World" and its 100-billion-yuan objective. The recent approval of this new production facility,
 

Currently, Lunan Pharmaceutical is actively expanding into the international market. To advance its internationalization strategy, the company began establishing an international pharmaceutical R&D center in 2017. Currently, seven ANDAs, including Isosorbide Mononitrate Sustained-Release Tablets, are under FDA review, with over 40 products in the development pipeline. The development and launch of additional products will help accelerate the company's expansion into global markets and enhance Lunan Pharmaceutical's brand image and influence both domestically and internationally.