Sanofi Receives Chinese Approval for Myqorzo and Redemplo in Cardiovascular and Rare Metabolic Diseases

(IN BRIEF) Sanofi has secured regulatory approval in China for two innovative medicines, Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronemia syndrome. The approvals expand treatment options for patients with serious cardiovascular and rare metabolic diseases and underscore Sanofi’s long-term commitment to bringing transformative therapies to Greater China. Supported by positive Phase 3 clinical data, both medicines address significant unmet medical needs and strengthen Sanofi’s presence in specialty and rare disease care in China.

(PRESS RELEASE) PARIS, 16-Jan-2026 — /EuropaWire/ — Sanofi has received regulatory approval in China for two innovative medicines, marking a significant milestone in the company’s long-term commitment to addressing high unmet medical needs in the region. China’s National Medical Products Administration has approved Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS who are managed through dietary control.

The approvals reinforce Sanofi’s strategic focus on delivering transformative therapies for patients living with complex and often underserved conditions in Greater China. Both medicines expand available treatment options in disease areas where current standards of care remain limited.

Myqorzo is a selective, small-molecule cardiac myosin inhibitor developed to improve functional capacity and alleviate symptoms in patients with oHCM, a condition in which abnormal thickening of the heart muscle restricts blood flow and impairs cardiac function. The approval in China is supported by positive results from the pivotal global SEQUOIA-HCM Phase 3 clinical study, which demonstrated meaningful clinical benefits in patients with symptomatic oHCM.

Redemplo, a small-interfering RNA therapy, targets the production of apolipoprotein C-III, a key driver of severely elevated triglyceride levels in patients with FCS. The approval was based on data from the PALISADE Phase 3 study, which showed significant triglyceride reduction in patients with genetically confirmed or clinically diagnosed FCS. FCS is a rare and severe metabolic disorder associated with life-threatening complications such as acute pancreatitis and chronic systemic symptoms.

Hypertrophic cardiomyopathy is the most common inherited cardiovascular disease and carries a risk of serious complications including arrhythmias, stroke, heart failure, and sudden cardiac death. Approximately two-thirds of patients experience the obstructive form of the disease, which is associated with more severe symptoms and functional limitations. By targeting the underlying hypercontractility of the heart muscle, Myqorzo represents a disease-specific approach designed to modify cardiac mechanics rather than solely manage symptoms.

Redemplo addresses a critical unmet need in FCS, a condition characterized by triglyceride levels far exceeding normal ranges and limited therapeutic options. By silencing the gene responsible for apoC-III production, Redemplo offers a targeted and sustained mechanism to lower triglyceride levels and reduce the risk of severe complications.

Both therapies have received multiple regulatory designations globally, including breakthrough therapy and orphan drug status in major markets. Myqorzo is already approved in the United States and China, with a positive opinion recently adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use and a final EU decision expected in early 2026. Redemplo is approved in the United States, Canada, and China, with regulatory review ongoing in the European Union.

The approvals in China reflect Sanofi’s continued investment in innovation and partnerships to expand access to advanced therapies in Greater China, supporting patients with rare and complex diseases through science-driven solutions.

About HCM
HCM is the most common inherited cardiovascular disorder, characterized by abnormal thickening of the heart muscle (myocardium). This leads to the left ventricle becoming smaller and stiffer, impairing its ability to relax and fill with blood, limiting the heart’s pumping function and exercise capacity. HCM symptoms include: chest pain, dizziness, shortness of breath, or fainting during physical activity.

HCM has two forms: oHCM (two-thirds of patients), where thickened muscle blocks blood flow, and non-obstructive HCM (one-third), where the muscle is thickened but blood flows normally.
HCM patients face serious complications including atrial fibrillation, stroke, and mitral valve disease. It’s a leading cause of sudden cardiac death in young people and athletes due to dangerous heart rhythm abnormalities. Some patients have a high risk of progressive diseases leading to dilated cardiomyopathy and heart failure requiring transplantation.

About Myqorzo
Myqorzo (aficamten) is a selective, small-molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties. Myqorzo was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM. In preclinical models, Myqorzo reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. Myqorzo is approved in the US and China.

Myqorzo, for the treatment of symptomatic oHCM, was designated breakthrough therapy and orphan drug in the US, and breakthrough therapy in China. On December 12, 2025, The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization in the EU with a final decision expected in the first quarter of 2026. In December 2024, Sanofi obtained exclusive rights to develop and commercialize Myqorzo in Greater China for treating both forms of HCM. These rights came through an agreement with Corxel Pharmaceuticals, who had acquired them from Cytokinetics.

About FCS
FCS is a severe and rare disease leading to extremely high triglyceride levels, over 880 mg/dL (9.94 mmol/L). Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues.

About Redemplo
Redemplo (plozasiran) is a siRNA medicine suppressing the production of apoC-III, a protein produced primarily in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, Redemplo delivers significant reductions in triglyceride levels. Redemplo has been studied in both genetically confirmed and clinically diagnosed patients living with FCS. Redemplo, for the treatment of FCS, was designated breakthrough therapy, fast track, and orphan drug in the US, orphan in the EU, and breakthrough therapy in China. Redemplo is approved in the US, Canada, and China for the treatment of FCS patients. Regulatory review is ongoing in the EU.

In August 2025, Sanofi acquired the rights to develop and commercialize Redemplo in Greater China from Visirna Therapeutics, a majority-owned subsidiary of Arrowhead Pharmaceuticals.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Sanofi Receives Chinese Approval for Myqorzo and Redemplo in Cardiovascular and Rare Metabolic Diseases

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