On August 4, a reporter from the International Financial News learned from SanofiChina has learned that the company has stopped supplying its new lipid-lowering drug, Praluent (alirocumab injection), to the Chinese market. The main reasons for the suspension are global supply issues and the company's cardiovascular market strategy and pipeline optimization.

According to industry media reports, many hospitals have recently received official notifications from Sanofi .

Praluent confirms his withdrawal

According to the data, Praluent is a new lipid-lowering drug of the PCSK9 inhibitor class, which is mainly used for the prevention of cardiovascular events, primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. The drug is one of the first PCSK9 monoclonal antibodies to be marketed in the world. It was approved in the United States in 2015 and was included in the China Innovative Drug List in 2019.It will be included in the priority review catalog, accelerated to market launch in 2020, and officially included in the national medical insurance in 2021. The price will be significantly reduced from 1,982 yuan/unit to 306 yuan/unit, and it will enjoy the Class B medical insurance reimbursement ratio.

Although it has completely withdrawn, Sanofi stated that it will not give up the gap in the cardiovascular pipeline after the withdrawal of Polyda. The company has acquired the rights of Jixing Pharmaceutical to exclusively develop and commercialize Aficamten (a new cardiac myosin inhibitor) in Greater China at the end of 2024. Recently, it also announced that it has obtained the rights of Viagen's investigational drug Pleslan Sodium Injection in Greater China. The company's cardiovascular product strategy in China will be comprehensively upgraded to continue to provide innovative products in different fields to meet the needs of domestic patients. In addition, it will continue to cooperate with medical services.Close communication between institutions and medical professionals is done to minimize the impact on patients.

Aficamten is a next-generation, selective small molecule cardiac myosin inhibitor targeting obstructive hypertrophic cardiomyopathy (OHCM). It reduces myocardial contractility and alleviates obstructive symptoms by reducing cardiac myosin cross-bridge activation. It has received Breakthrough Therapy designation from both Chinese and US drug regulatory authorities. Its application for marketing approval in China was submitted in October 2024 and received Priority Review. Its application for marketing approval in the US has also been accepted, with approval expected in September 2025.

There are 6 more targeted products on the market

Public information shows that there are currently 7 PCSK9-targeted products approved for marketing in China. Among them, 3 are from multinational pharmaceutical companies, namely Amgen's Ivolumab Injection (trade name: Repatha), Sanofi's Polydapoxetine, and Novartis's Inkerabol Sodium (trade name: Levitra).

There are also 4 products from domestic pharmaceutical companies, namely, Tolcizumab (trade name: Xinbi Le) from Innovent Biologics , Inusinumab (trade name: Yixining) from Kangfang Biopharma , Ongoriximab (trade name: Junshida) from Junshi Biopharma, and Hengrui Medicine.Among them, Amgen 's Evolucrumab Injection, Sanofi's Poleda, and Innovent Biologics ' Tolcizumab Injection have all been included in the national medical insurance catalog. Even with Poleda's withdrawal, patients still have other options.

Repatha was included in the national medical insurance catalogue in 2021. The post-medicalization price is approximately 283 yuan per vial, with a 1ml:140mg vial. A box of two 1ml:140mg vials costs approximately 566 yuan. Innovent Biologics ' Symbirol was included in the updated national medical insurance catalogue in 2024, with coverage effective January 1, 2025. Medical insurance reimbursement is capped at no more than 300 yuan per vial. For example, a 600mg dose every six weeks would cost approximately 3,000 yuan annually. Depending on regional medical insurance policies, out-of-pocket expenses could be even lower.

On July 31st, Sanofi released its semi-annual report, showing that second-quarter revenue reached €10 billion (approximately $11.4 billion), a 10.1% increase. For the first half of this year, the company achieved total revenue of €19.889 billion (approximately $22.8 billion), a 9.9% increase. (Exchange rate: €1 = $1.14). R&D investment was €3.717 billion (approximately $4.2 billion), accounting for 18.7% of total revenue.

Sanofi currently has 82 research projects in four major disease areas (immunology, rare diseases, neurology and oncology) and vaccines, including 40 potential new drugs and vaccines.

In terms of regional revenue, in the first half of this year: Sanofi's revenue in the US market was the highest, at 9.535 billion euros (about 10.88 billion US dollars), an increase of 16.4%; sales in the European market were 4.144 billion euros (about 4.72 billion US dollars), an increase of 1.8%; revenue in the Chinese market was 1.388 billion euros (about 1.58 billion US dollars), an increase of 0.1%.

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