NMPA approves Redemplo (plozasiran) for familial chylomicronemia syndrome in China – Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals, Inc. announced that the Chinese National Medical Products Administration (NMPA) has approved Redemplo (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. Redemplo will be marketed in Greater China by Sanofi under an agreement between Sanofi and Arrowhead. In 2025, Sanofi purchased those rights from Visirna, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead’s investigational cardiometabolic candidates in Greater China.

Approval in China marks the third regulatory approval for Redemplo, following recent approvals by the FDA and Health Canada, as an adjunct to diet to reduce triglycerides in adults with FCS. Redemplo is also in review for marketing authorization by additional global regulatory authorities. Redemplo is the first and only U.S. FDA-approved, Health Canada-approved, and China NMPA-approved siRNA medicine for people living with FCS and can be self-administered at home with a simple subcutaneous injection once every three months.

“NMPA approval of Redemplo for FCS in China is another positive step and continues the strong momentum since launching in the U.S. in November 2025. We look forward to working with Sanofi, an innovative global company with an established presence in China,” said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. “We are happy to report encouraging initial response from physicians and patients following FDA approval and launch in the U.S. last month. We intend to continue building on this rapid progress and anticipate additional commercial launches in 2026, pending regulatory review and approval.”