China’s NMPA has approved two Sanofi-licensed therapies, Myqorzo for obstructive hypertrophic cardiomyopathy and Redemplo for familial chylomicronaemia syndrome, bringing innovative treatment options to patients with rare cardiovascular and metabolic disorders in Greater China.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
China’s National Medical Products Administration (NMPA) has granted marketing approval to two innovative therapies licensed by Sanofi. Myqorzo (Aficamten) has been approved for obstructive hypertrophic cardiomyopathy (oHCM), and Redemplo (Plozasiran) for familial chylomicronaemia syndrome (FCS) in adults managed with dietary control. These approvals address unmet needs in rare disease care and support broader access to novel mechanisms of action in Greater China.
Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy
Myqorzo (Aficamten), is a selective cardiac myosin inhibitor designed to modify the underlying contractile dysfunction in oHCM. This genetic heart disease is characterized by abnormal thickening of the myocardium, which particularly impacts blood flow out of the left ventricle and limits exercise capacity. Patients often experience shortness of breath, chest pain, light-headedness, and in some cases, sudden cardiac death.
The NMPA approval for Myqorzo is based on data from the pivotal SEQUOIA-HCM Phase 3 trial (NCT05186818), which demonstrated improved functional capacity and symptom relief in adults with symptomatic oHCM. The drug works by reducing the number of active actin-myosin cross bridges in the cardiac cycle, lowering excessive contractility and easing obstruction. Myqorzo was previously designated a breakthrough therapy and orphan drug in the United States and received breakthrough designation in China. It is also approved in the US, with regulatory review in the European Union moving forward.
Sanofi obtained exclusive rights to Myqorzo in Greater China through its agreement with Corxel Pharmaceuticals. This approval enhances treatment options in a condition where prior therapies were limited and reinforces efforts to expand innovative cardiovascular care in the region.
Redemplo (Plozasiran) for Familial Chylomicronaemia Syndrome
Redemplo (Plozasiran), is a small interfering RNA (siRNA) therapy targeting apolipoprotein C-III (apoC-III), a regulator of triglyceride metabolism. By silencing apoC-III production in the liver, Redemplo significantly lowers triglyceride levels, a key factor in FCS pathology. FCS is a rare genetic disorder that leads to extremely high triglyceride concentrations, increasing the risk of acute pancreatitis, chronic abdominal pain, fatty liver changes, and other serious complications.
The approval by China’s NMPA was grounded in positive results from the PALISADE Phase 3 trial (NCT05089084), which showed substantial reductions in triglycerides among adult patients with genetically confirmed or clinically diagnosed FCS. Redemplo received multiple designations including breakthrough therapy, fast track, and orphan drug status in the US and breakthrough therapy status in China. It is already approved in the United States and Canada, with ongoing regulatory review in the EU.
Sanofi secured the rights to develop and commercialize Redemplo in Greater China in 2025 through its agreement with Visirna Therapeutics, a majority-owned subsidiary of Arrowhead Pharmaceuticals. This strategic move supports broader availability of a first-in-class siRNA therapy in a region with high need for effective lipid-modulating treatments.
Olivier Charmeil, Executive Vice President, General Medicines, Sanofi welcomed the approvals, noting that both medicines mark meaningful progress for people living with complex, hard-to-treat conditions in the region. The company emphasized that introducing Myqorzo and Redemplo reflects its long-term focus on bringing advanced science to Chinese patients and strengthening access to innovative therapies.
References
Press Release: Myqorzo and Redemplo approved in China, January 15, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-15-06-00-00-3219227
Aficamten vs Placebo in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy (SEQUOIA-HCM) (SEQUOIA-HCM), ClinicalTrials.gov ID NCT05186818, https://clinicaltrials.gov/study/NCT05186818
Study of ARO-APOC3 (Plozasiran) in Adults with Familial Chylomicronemia Syndrome (FCS) (PALISADE), ClinicalTrials.gov ID NCT05089084, https://clinicaltrials.gov/study/NCT05089084