China NMPA approves Sanofi’s Myqorzo for oHCM and Redemplo for FCS
The National Medical Products Administration approved Sanofi’s Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and Redemplo (plozasiran) for familial chylomicronaemia syndrome in adult patients. Approvals follow positive SEQUOIA-HCM and PALISADE phase III trials and grant Sanofi exclusive Greater China commercialization rights, bolstering its rare disease portfolio.
1. Strategic Expansion into Greater China
On January 15, 2026, China’s National Medical Products Administration granted marketing authorization for two Sanofi-licensed therapies—Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for familial chylomicronemia syndrome (FCS). These approvals mark Sanofi’s third and fourth innovative product launches in Greater China over the past 18 months, reinforcing its commitment to address rare and serious diseases in a market projected to exceed $70 billion in specialty pharmaceuticals by 2030. Sanofi obtained exclusive Greater China rights for Myqorzo in December 2024 from Corxel Pharmaceuticals and for Redemplo in August 2025 from Visirna Therapeutics, underscoring its M&A-driven growth strategy in the region.
2. Myqorzo Delivers Targeted Therapy for oHCM
Myqorzo, a selective small-molecule cardiac myosin inhibitor, demonstrated a 44% reduction in clinical event risk versus placebo in the SEQUOIA-HCM Phase 3 trial (NCT05186818) involving 350 symptomatic oHCM patients. By modulating actin-myosin cross bridge formation, the therapy improved peak oxygen uptake by an average of 2.8 mL/kg/min and reduced NYHA class III–IV symptoms by 60% at 30 weeks. Following breakthrough therapy and orphan drug designations in the US and China, Myqorzo’s launch is expected to address a patient population of approximately 130,000 adults with oHCM in Greater China, where two-thirds exhibit left ventricular outflow tract obstruction.
3. Redemplo Targets Rare FCS with siRNA Innovation
Redemplo employs RNA interference to silence apolipoprotein C-III production, achieving mean triglyceride reductions of 75% at 24 weeks in the PALISADE Phase 3 study (NCT05089084) of 120 genetically confirmed or clinically diagnosed FCS patients. FCS affects fewer than 10,000 individuals in China but carries acute pancreatitis risk exceeding 30% annually and chronic complications such as hepatic steatosis and cognitive impairment. With prior approvals in the US and Canada and breakthrough, fast track, and orphan designations across major regulators, Redemplo’s entry into China expands Sanofi’s rare disease franchise and anticipates generating peak annual revenues exceeding $400 million in the next five years.