Press Release: Myqorzo and Redemplo approved in China

Core Insights - Sanofi has received approval from the National Medical Products Administration in China for two innovative medicines: Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for familial chylomicronaemia syndrome (FCS) [1][2][9] Myqorzo (aficamten) - Myqorzo is a selective, small-molecule cardiac myosin inhibitor designed to improve functional capacity and relieve symptoms in patients with oHCM, the most common monogenic inherited cardiovascular disorder [2][7] - The approval was based on the positive results from the pivotal SEQUOIA-HCM phase 3 study (clinical study identifier: NCT05186818) [2] - Myqorzo has been designated as breakthrough therapy and orphan drug in the US, and breakthrough therapy in China, with a positive opinion for marketing authorization in the EU expected in Q1 2026 [8] Redemplo (plozasiran) - Redemplo is a small-interfering RNA (siRNA) medicine that suppresses the production of apoC-III, targeting triglyceride reduction in patients with FCS, a severe and rare disease characterized by extremely high triglyceride levels [3][11] - The approval was based on the positive results from the pivotal PALISADE phase 3 study (clinical study identifier: NCT05089084) [3] - Redemplo has received multiple designations including breakthrough therapy and orphan drug in the US, and is also approved in Canada and China for treating FCS patients [11][12] Hypertrophic Cardiomyopathy (HCM) - HCM is characterized by abnormal thickening of the heart muscle, leading to impaired heart function and various symptoms such as chest pain and shortness of breath [4][5] - It has two forms: obstructive HCM (oHCM) affecting two-thirds of patients and non-obstructive HCM affecting one-third [5] - Serious complications from HCM include atrial fibrillation, stroke, and it is a leading cause of sudden cardiac death in young people [6] Familial Chylomicronaemia Syndrome (FCS) - FCS is a rare disease leading to triglyceride levels exceeding 880 mg/dL (9.94 mmol/L), which can result in severe complications such as pancreatitis and diabetes [10] - The approval of Redemplo addresses a significant unmet medical need for patients suffering from this condition [3][11] Sanofi's Commitment - The approvals of Myqorzo and Redemplo highlight Sanofi's long-term commitment to providing innovative medicines to patients in China, particularly in areas with large unmet medical needs [2][9]