Sanofi Secures China Rights to RNAi Candidate for Hypertriglyceridemia from Arrowhead
In a major regional licensing agreement, Sanofi has entered into an asset purchase deal with Visirna Therapeutics, a majority-owned subsidiary of Arrowhead Pharmaceuticals, to acquire the rights to the investigational RNAi therapy plozasiran for the Greater China region.
Sanofi-Visirna Deal Worth Up to $395M for Greater China Rights to RNAi Candidate
Under the terms of the agreement, Sanofi will make an upfront payment of $130 million to Visirna and may pay up to $265 million in potential milestone payments linked to regulatory achievements in mainland China. The acquisition grants Sanofi exclusive rights to develop and commercialise plozasiran in the region. This first-in-class RNA interference (RNAi) candidate is being developed to reduce apolipoprotein C-III (APOC3) production, targeting conditions such as familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG).
The asset transfer builds on Visirna’s prior efforts in Greater China, where it has led the clinical development of plozasiran. A Phase 3 clinical trial (CTR20231418/NCT05902598) in Chinese FCS patients met its primary efficacy endpoint and all key secondary endpoints. Following trial success, Visirna submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA), which was officially accepted in January 2025. The therapeutic has also received Breakthrough Therapy Designation and Priority Review Designation from the NMPA.
Christopher Anzalone, Ph.D., Arrowhead’s President and CEO, stated:
“When we founded Visirna in 2022, we believed that Greater China represented an important potential future market for multiple programs in Arrowhead’s pipeline of investigational RNAi-based candidates for cardiometabolic diseases. The team at Visirna understand the intricacies of China’s clinical, regulatory, and commercial environment and have done impressive work moving plozasiran through clinical studies and into the regulatory submission and review process. We now look forward to working with Sanofi and believe they are extremely well positioned as a global company with a strong presence in China.”
Wayne Shi, President, Sanofi Greater China, added:
“We are pleased to have concluded this agreement to enable us to advance plozasiran in Greater China where Sanofi has deep roots and a proud heritage of serving people living with a wide range of diseases. Plozasiran has shown considerable potential in studies across diverse patient populations where serious illness is caused by elevated triglycerides. With our strong presence in China’s cardiometabolic field, we now look forward to bringing it forward to address unmet need.”
In addition to the initial and milestone payments, Arrowhead is eligible to receive royalties on future net sales in Greater China under its licensing agreement with Visirna, which has been partially transferred to Sanofi. The legal advisors on the deal include Gibson, Dunn & Crutcher LLP and Sidley Austin LLP, representing Arrowhead.
About Plozasiran
Plozasiran, formerly known as ARO-APOC3, is a first-in-class investigational RNA interference therapeutic specifically engineered to suppress APOC3, a protein that plays a key role in triglyceride regulation by preventing the breakdown and liver clearance of triglyceride-rich lipoproteins (TRLs). The therapeutic strategy aims to lower APOC3 levels, consequently reducing triglycerides and promoting healthier lipid profiles.
Across multiple clinical trials, plozasiran has demonstrated the ability to lower triglycerides and atherogenic lipoproteins in patients with FCS, SHTG, and mixed hyperlipidemia. The treatment has generally shown good tolerability, with treatment-emergent adverse events reflective of the underlying health conditions in study participants. The most frequently observed adverse events at the proposed 25 mg marketing dose included COVID-19, upper respiratory tract infection, headache, Type 2 diabetes mellitus, and abdominal pain.
Plozasiran is being evaluated in the SUMMIT program, which includes:
PALISADE Phase 3 trial for FCS
SHASTA Phase 2 and 3 studies for SHTG
MUIR Phase 2 and 3 trials for mixed hyperlipidemia
Globally, plozasiran has received Breakthrough Therapy, Orphan Drug, and Fast Track Designations from the U.S. FDA, as well as Orphan Medicinal Product Designation from the European Medicines Agency (EMA). Marketing applications have been filed with multiple regulatory bodies, though the therapy is not yet approved for use in any market.
About Visirna Therapeutics
Founded in 2022, Visirna Therapeutics is a majority-owned subsidiary of Arrowhead Pharmaceuticals, headquartered in China, with a global development vision. Visirna specialises in the development of siRNA therapeutics, with a focus on cardiovascular/metabolic and autoimmune diseases, and currently maintains a pipeline of clinical-stage candidates.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals focuses on the development of gene-silencing therapies to combat severe diseases by leveraging RNA interference (RNAi) technology. Through a range of RNA chemistries and targeted delivery platforms, Arrowhead aims to induce potent, sustained silencing of disease-driving genes. RNAi is a natural cellular mechanism that inhibits gene expression and consequently protein production, making it a powerful approach to therapeutic development.
For more details, visit www.arrowheadpharma.com
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