China’s National Medical Products Administration (NMPA) has approved two Sanofi-licensed innovative medicines, Myqorzo (aficamten) and Redemplo (plozasiran), expanding advanced treatment options for patients with complex and rare diseases in Greater China.
Myqorzo has been approved for the treatment of adults with obstructive Hypertrophic Cardiomyopathy (oHCM), while Redemplo has received approval to reduce triglyceride levels in adult patients with Familial Chylomicronaemia Syndrome (FCS) who are managed through dietary control.
Commenting on the approvals, Olivier Charmeil, Executive Vice President, General Medicines at Sanofi, said, “The launches reflect our company’s long-term commitment to addressing unmet medical needs in China. Both therapies represent important advances for patients living with serious and complex conditions.”
Myqorzo is a selective, small-molecule cardiac myosin inhibitor designed to improve functional capacity and relieve symptoms in patients with oHCM, the most common inherited cardiovascular disorder. The condition is characterised by abnormal thickening of the heart muscle, which restricts blood flow and limits the heart’s ability to pump efficiently. The NMPA approval was supported by positive results from the pivotal Phase III Sequoia-HCM trial.
Hypertrophic cardiomyopathy affects heart function and exercise capacity, with symptoms including chest pain, shortness of breath, dizziness and fainting during physical activity. Approximately two-thirds of patients have the obstructive form of the disease, which can lead to serious complications such as atrial fibrillation, stroke, heart failure and sudden cardiac death.
Myqorzo works by reducing myocardial hypercontractility through selective inhibition of cardiac myosin, limiting force producing actin-myosin interactions. The therapy has been granted breakthrough therapy and orphan drug designations in the US and breakthrough therapy status in China. It is already approved in the US and China, with a positive opinion from the European Medicines Agency’s CHMP issued in December 2025 and a final EU decision expected in early 2026. Sanofi secured exclusive rights to develop and commercialise Myqorzo in Greater China in December 2024.
Redemplo is a small-interfering RNA (siRNA) therapy that targets apolipoprotein C-III (apoC-III), a key regulator of triglyceride metabolism. By suppressing apoC-III production, Redemplo significantly lowers triglyceride levels in patients with FCS, a rare and severe genetic disorder characterised by extremely high triglycerides that can lead to acute pancreatitis, chronic abdominal pain, diabetes, liver disease and neurological complications.
The approval of Redemplo was based on positive results from the Phase III Palisade study in patients with genetically confirmed or clinically diagnosed FCS. The therapy has received multiple regulatory designations, including breakthrough therapy, fast track and orphan drug status in the US, orphan designation in the EU, and breakthrough therapy designation in China. Redemplo is approved in the US, Canada, and China, with regulatory review ongoing in the EU.
In August 2025, Sanofi acquired the rights to develop and commercialise Redemplo in Greater China from Visirna Therapeutics, a majority-owned subsidiary of Arrowhead Pharmaceuticals.
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