Sanofi Secures Two Market Authorizations in China
The Chinese National Medical Products Administration has approved two Sanofi-licensed drugs, according to the company's statement. These are Myqorzo (aficamten), aimed at treating obstructive hypertrophic cardiomyopathy, and Redemplo (plozasiran), indicated for reducing triglycerides in adults with familial chylomicronemia syndrome.
Introduction of Myqorzo for Cardiac Treatment
The first approved drug, Myqorzo, is a selective cardiac myosin inhibitor designed to improve the functional capacity of patients with obstructive hypertrophic cardiomyopathy, the company states. This condition, where the heart muscle abnormally thickens, is the most common monogenic hereditary cardiovascular disease, according to the announcement. The Chinese approval is based on the phase 3 SEQUOIA-HCM study conducted in patients with this symptomatic obstructive form. The drug aims to reduce the number of active actin-myosin bridges in each cardiac cycle, thus suppressing the myocardial hypercontractility associated with the disease. Myqorzo had previously been authorized in the United States and holds the status of an innovative treatment in China. The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on December 12, 2025, with a final decision expected in the first quarter of 2026. In December 2024, Sanofi acquired exclusive rights to develop and market this drug in Greater China from Corxel Pharmaceuticals, which held them through Cytokinetics.
Redemplo Approved for Treating Familial Chylomicronemia Syndrome
The second authorized drug, Redemplo, is an RNA interference therapy that suppresses the production of apoC-III, a hepatic protein that increases triglyceride levels, the group specifies. It is intended for adult patients with familial chylomicronemia syndrome, a rare and severe disease characterized by extremely high triglyceride levels, over 880 mg/dl. This hypertriglyceridemia can lead to serious complications, including potentially fatal acute pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive disorders, according to the statement. The approval is based on the phase 3 PALISADE study conducted in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome. Redemplo has been granted breakthrough therapy status in the United States and China, as well as orphan drug status in the United States and the European Union. The drug is already approved in the United States and Canada, and a regulatory review is ongoing in the European Union. Sanofi acquired the development and commercialization rights in Greater China in August 2025 from Visirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals.
Strategic Implications for Sanofi in the Chinese Market
These two authorizations align with the French laboratory's strategy in the Chinese market, according to the group. Olivier Charmeil, Executive Vice President of General Medicine at Sanofi, stated that these drugs represent advancements in treatment options and address unmet medical needs. The approvals underscore the group's long-term commitment to providing innovative medicines to Chinese patients, as reported in the statement. For Myqorzo, the rights were acquired in December 2024 from Corxel Pharmaceuticals to treat both forms of hypertrophic cardiomyopathy in Greater China. For Redemplo, the rights acquisition dates back to August 2025 from Visirna Therapeutics. These transactions enable the group to strengthen its portfolio of innovative drugs in a strategic market. Hypertrophic cardiomyopathy affects about two-thirds of patients in its obstructive form, while familial chylomicronemia syndrome remains a rare pathology requiring specific treatments.
