Sanofi Discontinues Praluent Supply to China Amid Global Demand Surge and Local Competition
核心洞察
Sanofi has stopped supplying Praluent, its cholesterol-lowering PCSK9 inhibitor, to China due to limited global availability and surging demand that accelerated sharply over the past two years.
The withdrawal is attributed to increasing competition from domestic PCSK9 inhibitors included in China's national medical insurance reimbursement list and global supply chain challenges for active pharmaceutical ingredients.
Praluent generated approximately CNY850 million in Chinese hospital sales last year with a 26% market share, making it the second-largest PCSK9 inhibitor in China after Amgen's Evolocumab.
Sanofi announced Tuesday it has ceased supplying Praluent (alirocumab), its cholesterol-lowering PCSK9 inhibitor jointly developed with Regeneron Pharmaceuticals, to the Chinese market due to limited global availability driven by surging worldwide demand.
"The surge in demand has led to limited availability in China, and some other countries," Sanofi stated, confirming that "at the moment Praluent's supply in China has already stopped." The company did not specify when supply might resume.
Market Dynamics Drive Strategic Withdrawal
The discontinuation reflects multiple market pressures affecting Praluent's position in China. According to a Sanofi spokesperson, the drug's exit is partly attributed to the increasing inclusion of domestic PCSK9 inhibitors in China's national medical insurance reimbursement list, creating a more diversified market supply landscape.
Global supply chain challenges for active pharmaceutical ingredients have also impacted Praluent's availability in China, the company noted. Sanofi indicated it has "invested to strengthen global production of Praluent, to meet a rising global demand which accelerated sharply over the past two years."
Strong Market Performance Before Exit
Despite its withdrawal, Praluent demonstrated significant commercial success in China. The drug's sales in Chinese hospitals across all channels, including primary healthcare institutions, reached approximately CNY850 million (USD118 million) last year, capturing around 26% market share in the PCSK9 inhibitor segment.
This performance made Praluent the second-largest PCSK9 inhibitor in China, trailing only Amgen's Evolocumab, which generated CNY1.4 billion (USD192 million) in sales. The drug's commercial trajectory was particularly notable following its inclusion in China's 2021 national medical insurance negotiations list, where its price was significantly reduced from CNY1,982 to CNY306 (USD275 to USD42.65) per injection, leading to triple-digit sales growth from 2022 to 2023.
Clinical Context and Patient Transition
PCSK9 inhibitors like Praluent serve as treatment options for approximately 10% to 20% of hyperlipidemia (搜索) patients who do not achieve satisfactory results with mainstream first-line lipid-lowering medications such as statins and fibrates. Praluent became only the second imported PCSK9 inhibitor approved in China in December 2019.
China has approved seven PCSK9 inhibitors total, including three imported and four domestic products, with three currently included in the national medical insurance reimbursement catalog, including Praluent.
Sanofi emphasized that clinical experts have identified other medicines on China's National Reimbursement Drug List that are "safe and appropriate" for patients currently treated with Praluent. The company is collaborating with healthcare providers in China to "ensure a smooth transition for patients."
Broader Industry Trend
Sanofi's decision reflects a broader pattern of foreign pharmaceutical companies suspending supplies to China. Merck (搜索) previously suspended shipments of its HPV vaccine Gardasil to China in February, citing weak discretionary spending.
Despite Praluent's withdrawal, Sanofi indicated it continues working on establishing a new cardiovascular product pipeline in the Chinese market, suggesting ongoing commitment to the therapeutic area despite this specific product discontinuation.