China Approves Two Sanofi-Licensed Breakthrough Medicines for Rare and Cardiovascular Diseases
China’s National Medical Products Administration (NMPA) has approved two innovative Sanofi-licensed therapies, expanding options for patients with serious unmet medical needs.
The approvals cover Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and Redemplo (plozasiran) for familial chylomicronaemia syndrome.
What Was Approved—and Why It Matters?
Sanofi will bring both medicines to patients across Greater China, reinforcing its long-term innovation strategy in the region.
According to Sanofi, both therapies address complex, underserved conditions with limited treatment options.
Myqorzo (Aficamten): A New Option for oHCM
Myqorzo is a selective cardiac myosin inhibitor designed to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
oHCM is the most common inherited cardiovascular disorder, caused by abnormal thickening of the heart muscle.
This thickening restricts blood flow, reduces exercise capacity, and increases the risk of serious cardiac events.
Clinical Basis for Approval
Approval based on the SEQUOIA-HCM Phase 3 trial
Demonstrated improvement in functional capacity and symptom relief
Targets myocardial hypercontractility at its source
Regulatory Status Highlights
Approved in the US and China
Breakthrough therapy and orphan drug designations in the US
Positive CHMP opinion in the EU, with final decision expected in Q1 2026
Sanofi holds exclusive Greater China rights, acquired through Corxel Pharmaceuticals.
Redemplo is a small-interfering RNA (siRNA) therapy for familial chylomicronaemia syndrome (FCS). FCS is a rare, life-threatening disease marked by triglyceride levels exceeding 880 mg/dL. These extreme levels can cause acute pancreatitis, chronic pain, diabetes, and liver disease.
How Redemplo Works?
Silences production of apoC-III in the liver
Improves triglyceride breakdown and clearance
Delivers sustained triglyceride reduction
Clinical and Regulatory Profile
Approval based on the PALISADE Phase 3 trial
Approved in the US, Canada, and China
EU regulatory review is ongoing
Breakthrough, fast track, and orphan designations across major markets
Sanofi acquired Greater China rights in August 2025 from Visirna Therapeutics.
The Bigger Picture
These approvals strengthen Sanofi’s presence in rare diseases and cardiology within China. They also reflect China’s growing openness to first-in-class and advanced RNA-based therapies.
Sanofi continues positioning itself as an R&D-driven, AI-powered biopharma, focused on high-impact innovation.