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  1. Home
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  3. China Approves Two Sanofi Licensed Breakthrough Medicines For Rare And Cardiovascular Diseases
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  • 19 Jan 2026
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  • News Article

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 (Plozasiran): Targeting Extreme Triglycerides

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.

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