China Approves Sanofi’s Myqorzo and Redemplo While U.S. Vaccine Demand Faces Headwinds

SNYSNY

China’s NMPA approved Sanofi’s Myqorzo (aficamten) for obstructive hypertrophic cardiomyopathy and Redemplo (plozasiran) for familial chylomicronaemia syndrome following positive phase 3 SEQUOIA-HCM and PALISADE trials. Meanwhile, CEO Paul Hudson warned of near-term U.S. vaccine demand weakness due to misinformation and heightened regulatory scrutiny.

1. Sanofi Secures Dual Approvals for Myqorzo and Redemplo in China

On January 15, 2026, China’s National Medical Products Administration granted approval for Myqorzo (aficamten) to treat obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS). The Myqorzo approval, based on the positive SEQUOIA-HCM phase 3 trial (NCT05186818), addresses oHCM—a condition affecting an estimated 1 in 500 individuals in Greater China—by targeting hypercontractility of the myocardium. Redemplo’s nod stems from the PALISADE phase 3 study (NCT05089084), which demonstrated mean triglyceride reductions exceeding 70% in genetically confirmed or clinically diagnosed FCS patients, a population characterized by baseline levels above 880 mg/dL and at high risk of acute pancreatitis and hepatic steatosis. These approvals follow Sanofi’s December 2024 and August 2025 agreements securing Greater China commercialization rights for Myqorzo and Redemplo, respectively, underscoring the company’s strategy to invest in high-unmet-need cardiovascular and rare lipid disorders within a market exceeding 1.4 billion people.

2. U.S. Vaccine Demand Faces Near-Term Softness, Says CEO

Sanofi Chief Executive Paul Hudson cautioned on Wednesday that U.S. vaccine demand is likely to experience a modest downturn this year, attributing the trend to persistent misinformation campaigns and increased regulatory scrutiny under the current administration. He noted that orders for seasonal influenza and routine immunizations dipped by approximately 5% in the fourth quarter of 2025, compared with the same period in 2024, and forecast a similar or slightly larger decline through mid-2026. Hudson stressed that while this softness will temporarily weigh on quarterly revenue growth in the Vaccines Business Unit, Sanofi’s long-term outlook remains intact, driven by advanced candidate programs and ongoing investments in mRNA and adjuvanted platforms aimed at future pandemic preparedness.

Sources

GR