Visirna Therapeutics Enters into $395M Deal with Sanofi for Greater China Rights to Plozasiran, a First-in-Class RNAi Therapy Targeting APOC3

Aug 04, 2025 12:08 CST Updated 12:08

Visirna

siRNA Drug Developer

Sanofi

Pharmaceutical Manufacturer

On August 1 (local time), Arrowhead Pharmaceuticals announced that its holding subsidiaryVisirna Therapeutics (Weierzhen) Reaches Purchase Agreement with Sanofi, Sanofi will acquire VisirnaTargeted Apolipoprotein C-III (APOC3) RNAi TherapeuticsVSA001 (Plozasiran, Polusilan Sodium Injection, formerly known as ARO-APOC3)Greater China Development and Commercialization Rights.

According to the agreement, Visirna will receive from Sanofi, the press release said.$130 Million Upfront Payment, has the right to obtain after NMPA approves the relevant indicationsUp to $265 Million in Milestone Payments，Total USD 395 million (Current exchange rate: RMB 2.849 billion). At the same timeAs part of the Arrowhead-Visirna agreement,Arrowhead has the right to share the sales revenue in the Greater China region.

VSA001 (Plozasiran, Polasiran Sodium Injection, formerly known as ARO-APOC3)VSA001 is a first-in-class RNA interference (RNAi) therapeutic drug designed to reduce the production of apolipoprotein C-III (APOC3). APOC3 is a component of triglyceride-rich lipoproteins (TRLs) and a key regulator of triglyceride metabolism. APOC3 increases blood triglyceride levels by inhibiting the breakdown of TRLs by lipoprotein lipase and the uptake of TRL remnants by liver receptors. VSA001 reduces triglycerides and normalizes lipid levels by lowering APOC3.

In January, its New Drug Application (NDA) (acceptance number: JXHS2500018) was officially accepted by China's NMPA.Used to treat familial chylomicronemia syndrome (FCS).

In March, Visirna announced the topline results of its Phase 3 clinical study in Chinese FCS patients:

	Time Point	25mg Group	50mg Group
Percentage decrease in fasting serum triglycerides from baseline (%)	October	86	89
	December	72	79
Percentage decrease in serum apolipoprotein C3 (APOC3) from baseline (%)	October	93	92

In the VSA001 (25mg) group, 90% of patients had fasting serum triglyceride levels decrease to below 500mg/dL by the 10th month.

VSA001 also met all key secondary endpoints, including the percentage change in serum fasting triglycerides from baseline at Month 10 and Month 12, as well as the percentage change in APOC3 levels from baseline at Month 10 and Month 12.

VSA001 Demonstrates Good Safety in FCS Patients. The number of patients experiencing treatment-related adverse events (TEAEs) was similar between the VSA001 treatment group and the placebo group, while the incidence of serious adverse events was lower in the VSA001 treatment group compared to the placebo group.

In addition to FCS indications, VSA001 injection has been approved for two clinical trials in adult patients with severe hypertriglyceridemia (SHTG, TG≥500mg/dL) to reduce TG levels/prevent acute pancreatitis.

Three Phase 3 clinical trials have been conducted simultaneously in patients with severe hypertriglyceridemia:December Safety & Efficacy Clinical Study；24-Month Long-Term Safety Study；December Acute Pancreatitis (AP) Research。

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