Sanofi is handing over $130 million upfront for the China rights to Arrowhead Pharmaceuticals’ rare metabolic disease treatment that is currently being considered for approval by Chinese regulators.
The RNA interference (RNAi) therapeutic, called plozasiran, already aced a phase 3 trial last year, which tied 25-mg and 50-mg doses of the drug to 80% and 78% reductions, respectively, in triglycerides at 10 months for patients with familial chylomicronemia syndrome (FCS).
Since then, Arrowhead’s China-focused subsidiary Visirna Therapeutics has submitted an approval request to Chinese regulators.
Now, Sanofi wants in—paying Visirna $130 million upfront with the potential for $265 million in milestones to follow should plozasiran score Chinese approvals in FCS and various other indications. For its part, Arrowhead will be in line for royalties on sales from the greater China region as part of its licensing arrangement with Visirna.
Plozasiran is designed to lower the production of apolipoprotein C-III (APOC3), a part of triglyceride-rich lipoproteins and a regulator of triglyceride metabolism. Treatment with the drug aims to reduce APOC3 levels, therefore reducing triglycerides and restoring lipids to normal levels.
In the U.S., Arrowhead had already been beaten in a tight race to market by Ionis Pharmaceuticals’ antisense candidate Tryngolza, which secured FDA approval in FCS at the end of 2024. However, Ionis has yet to push for approval in China.
“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,” Arrowhead CEO Christopher Anzalone, Ph.D., said in an Aug. 1 release.
“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,” Anzalone added. “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.”
Sanofi ended last year scooping up the China rights to Cytokinetics’ hypertrophic cardiomyopathy drug aficamten, which is still awaiting a decision by Chinese regulators. That deal followed a move by the French pharma to establish a $1 billion manufacturing site in the country, marking the company’s largest investment in China to date.
Wayne Shi, president of Sanofi Greater China, put this morning’s deal in the context of the company’s “strong presence in China’s cardiometabolic field.”
“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,” Shi said.
“Plozasiran has shown considerable potential in studies across diverse patient populations where serious illness is caused by elevated triglycerides,” he added.