Domestic Pharmaceutical Companies Accelerate Differentiation Amid Shift to 'Value Competition' in China's Lipid-Lowering Drug Market

　　【Pharmaceutical Network Industry Dynamics】Lipid-lowering drugs refer to medications used to reduce cholesterol and triglyceride levels in the blood, primarily for the prevention and treatment of cardiovascular diseases. With the deepening of population aging and changes in lifestyle in China, a large number of patients are already required to take lipid-lowering drugs over the long term, while new patients are continuously increasing, providing broad development opportunities for the lipid-lowering drug market.
 

According to relevant data, the prevalence of dyslipidemia in China's population aged 18 and above has risen to 40.4%; In 2023, the sales revenue of China's lipid-lowering drug market has exceeded 30 billion yuan, with a clear trend of continuous growth. Currently, in response to the huge market demand for lipid-lowering drugs in China, pharmaceutical companies both domestic and international are increasingly investing in this area.
 

Recently, Hengrui Pharma's innovative drug SHR-1918 has been proposed for priority review for the treatment of adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
 

This drug is an ANGPTL3 monoclonal antibody that lowers triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) levels in the serum by inhibiting the activity of ANGPTL3. Previously, SHR-1918 was included in the list of breakthrough therapies by the CDE in 2024.
 

Previously, Hengrui Pharma also announced that HRS-5346 tablets, developed by its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd., have been included in the list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration. The drug is intended for the treatment of elevated lipoprotein(a) levels, an independent risk factor for atherosclerotic cardiovascular disease. According to the announcement, HRS-5346 tablets are an oral small-molecule inhibitor targeting lipoprotein(a). Currently, no similar products have been approved for marketing in China or globally.
 

On January 30, Chiesi China announced that its globally unique oral microsomal triglyceride transfer protein (MTP) inhibitor, lomitapide mesylate capsules, received approval from the National Medical Products Administration (NMPA). It can be used in combination with a low-fat diet and other lipid-lowering drugs (with or without low-density lipoprotein plasma separation) for the treatment of adult homozygous familial hypercholesterolemia (HoFH).
 

On January 6, Sanofi announced that the sodium injection of Volanesorsen (brand name: Rezuma) has been officially approved in China for reducing triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS) on the basis of dietary control. This drug is the world's first small interfering RNA drug targeting the innovative APOC3 (apolipoprotein C-III) mRNA.
 

On January 4, the CDE announced that DR10624 Injection, a Class 1 new drug submitted by Huadong Medicine's subsidiary Doer Biologics, is proposed to be included in the breakthrough therapy designation for the treatment of severe hypertriglyceridemia. DR10624, developed by Doer Biologics, is a tri-specific long-acting agonist targeting FGF21R, GCGR, and GLP-1R. It can simultaneously modulate the signaling pathways mediated by these three receptors, exerting synergistic effects to lower blood glucose, reduce weight, and decrease lipid levels.
 

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From an overall perspective, the current lipid-lowering drug market in China has demonstrated the characteristics of "price compression from generic drug procurement, domestic substitution of innovative drugs, and the rise of local players." Multinational pharmaceutical companies, leveraging their brand advantages and technological accumulation, dominate the high-end market. Meanwhile, local enterprises are accelerating the global R&D pipeline layout in areas such as PCSK9 inhibitors and small nucleic acid drugs through a dual-driven approach of "independent research and development + License-in." Industry insiders predict that in the future, pharmaceutical companies with comprehensive pipeline layouts, long-acting innovations, medical insurance coverage, and grassroots penetration capabilities will lead the market, while foreign-funded companies will continue to focus on premium long-acting and niche-target products.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.