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阿利西尤单抗为何在中国停供?赛诺菲:原料药供应紧张及管线优化
Bei Ke Cai Jing· 2025-08-05 11:51
Core Viewpoint - Sanofi has confirmed the cessation of the supply of Alirocumab injection (brand name: Praluent) in the Chinese market due to global raw material supply issues and a strategic shift in its cardiovascular market approach [1][3][5] Group 1: Product Information - Alirocumab is the first PCSK9 inhibitor approved globally, entering the Chinese market in December 2019, with indications for cardiovascular event prevention and lowering LDL cholesterol levels [2][3] - The drug was included in the national medical insurance directory in 2021, with its price reduced from 1982 yuan to 306 yuan per injection [2] Group 2: Market Dynamics - The competitive landscape for PCSK9 inhibitors is intensifying, with more domestic products being included in the 2025 National Medical Insurance Drug List, leading to a more diversified market [5][6] - The PCSK9 drug market in China is projected to reach 8.9 billion yuan by 2030, with a compound annual growth rate of 43.5% from 2022 to 2030 [6] Group 3: Company Strategy - Sanofi is optimizing its cardiovascular product pipeline and has acquired rights to develop and commercialize new drugs in the region, including aficamten and the investigational drug Plerixafor [3][7] - The company aims to align its product and pipeline decisions with China's health policy directives, focusing on chronic disease prevention and treatment [8]
赛诺菲降脂药波立达退出中国市场
Guo Ji Jin Rong Bao· 2025-08-04 12:20
Core Viewpoint - Sanofi has ceased the supply of its new lipid-lowering drug, Praluent (alirocumab injection), in the Chinese market due to global supply issues and a strategic shift in its cardiovascular market approach [1][4]. Company Summary - Sanofi has officially notified multiple hospitals about the discontinuation of Praluent in China [2]. - Praluent is a PCSK9 inhibitor used for the prevention of cardiovascular events and treatment of primary hypercholesterolemia and mixed dyslipidemia. It was one of the first PCSK9 monoclonal antibodies approved globally, receiving approval in the U.S. in 2015 and entering the Chinese market in 2020 [4]. - The price of Praluent in China was significantly reduced from 1982 RMB to 306 RMB per injection after being included in the national medical insurance [4]. - Despite the withdrawal of Praluent, Sanofi plans to fill the gap in its cardiovascular pipeline by acquiring exclusive rights to Aficamten, a new cardiac myosin inhibitor, in Greater China, and has also secured rights to another investigational drug, Plerixafor [4][5]. Industry Summary - There are currently seven approved PCSK9-targeted products in China, including three from multinational companies and four from domestic firms. The other products include those from Amgen, Novartis, and Innovent Biologics [7]. - Amgen's Repatha (evolocumab) and Innovent's Xinbile (torcetrapib) are among the alternatives available to patients following Praluent's exit [7]. - Sanofi's recent financial report indicated a revenue of 10 billion euros (approximately 11.4 billion USD) for Q2, with a 10.1% growth, and a total revenue of 19.889 billion euros (approximately 22.8 billion USD) for the first half of the year, reflecting a 9.9% increase [8].
确认!赛诺菲降脂药波立达拟退出中国市场
Di Yi Cai Jing· 2025-08-04 09:10
Core Viewpoint - Sanofi is rapidly filling its cardiovascular product pipeline through acquisitions while planning to exit the Chinese market for its cholesterol-lowering drug, Praluent (alirocumab) due to increased competition from domestic PCSK9 inhibitors and supply challenges [1][2][4]. Group 1: Market Strategy - Sanofi is optimizing its cardiovascular market strategy by discontinuing the promotion of Praluent in China, which is influenced by the inclusion of more domestic PCSK9 inhibitors in the National Medical Insurance Drug List by 2025 [1][2]. - The company confirmed the exit of Praluent from the Chinese market, citing both competitive and supply chain challenges [1][4]. Group 2: Product Pipeline - Sanofi has acquired rights to develop and commercialize the investigational drug, Patisiran sodium injection, in Greater China, which targets conditions like familial chylomicronemia syndrome and severe hypertriglyceridemia [5]. - Earlier, Sanofi also announced the acquisition of exclusive rights to develop and commercialize Aficamten in Greater China, a new generation selective small molecule cardiac myosin inhibitor [5].
独家|赛诺菲确认阿利西尤单抗注射液停供 在华心血管产品策略将升级
news flash· 2025-08-04 05:06
Core Viewpoint - Sanofi has confirmed the cessation of the supply of its drug, Praluent (alirocumab injection), in the Chinese market due to global supply issues and a strategic upgrade in its cardiovascular product offerings in China [1] Group 1: Supply and Strategic Changes - The decision to stop supplying Praluent is attributed to global supply challenges [1] - Sanofi is upgrading its cardiovascular product strategy in China, which includes a partnership with Jinxing Pharmaceutical for Aficamten and acquiring rights for the investigational drug, Plerixafor [1] - The company emphasizes its commitment to continue providing a range of products to meet the needs of domestic patients [1]