｜Edited by the Content Team of Zhong肽 Biochemical2026Year1June, Sanofi announcedClass 1 New Drug "Plethran Sodium Injection"Has been approved for marketing in China, and on the basis of dietary control, it is used to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS). Previously, the drug had been included in the priority review and breakthrough therapy designation."After this approval,Pulesran SodiumBecomes the first effective drug for FCS approved in China。Pulselan Sodium（Plozasiran，R&D Code:VSA001）It is a first-in-class liver-targeted small interfering RNA (siRNA) drug., administered once every 3 months, efficiently and durably silences apolipoprotein C-III（APOC3）The mRNA level is to reduce the expression of the APOC3 protein, thereby effectively reducing serum TG and TG-rich lipoproteins and their degradation residue levels.The drug was initially developed by Arrowhead, a leading small nucleic acid company.In April 2022, Arrowhead announced andVivo CapitalEstablishment of the joint venture Visirna Therapeutics to expand the business scope of innovative drugs in Greater China. Visirna has obtained an exclusive license to develop and commercialize four investigational RNAi therapies targeting cardiovascular and metabolic diseases in Greater China, including Pulesiran Sodium.In August 2025, Sanofi acquired the Greater China rights to Praliclan sodium for an upfront payment of $130 million and up to $265 million in additional milestone payments, making it one of Sanofi's key cardiovascular-focused initiatives in China.The approval of Plerixafor Sodium in China is mainly based on includingKey Points in Adult Patients with FCSPhase III Trial(PALISADE Study)Positive results from multiple overseas studies, including those in China, and Phase I trials in China.PALISADE Study（NCT05089084）It is a randomized, double-blind, placebo-controlled Phase III clinical trial. A total of 75 subjects were enrolled in the study.(Distributed across different research centers in 18 countries), randomly assignedPuleslan Sodium 25 mg(26 cases)、50 mg(24 cases)Or placebo(25 cases)Subcutaneous injection treatment for 12 months. Subjects who complete the randomization period are eligible to continue participating in the extension period study.The primary endpoint of the PALISADE study was the median triglyceride level at the 10th month, adjusted for placebo.（TG）Horizontal changes. The results showed,Receive 25 mg or 50 mgPulersilan SodiumPatients treated achieved median triglyceride level reductions of 80% and 78%, respectively.In addition to achieving the primary endpoint, the study also met all key secondary endpoints.
Throughout the study period,Plethran SodiumContinuously Reduce Triglyceride Levels(Median and Mean), with low variability, while demonstrating good safety.
In March 2025, Visirna announced that the Phase III clinical trial (CTR20231418/NCT05902598) of volanesorsen sodium for Chinese FCS patients also achieved positive topline data, successfully meeting the primary efficacy endpoint and all key secondary endpoints.This is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial, with a total of 37 FCS patients randomly assigned to receiveOnce every 3 months, a 12-month treatment with VSA001 25 mg, 50 mg, or placebo subcutaneous injections aims to evaluate the efficacy and safety of VSA001 in Chinese FCS adult patients.The primary endpoint of the study was compared with the placebo group,The median percentage change in fasting serum triglyceride levels from baseline to Month 10.
Data shows,Fasting serum triglyceride levels in FCS patients treated with 25 mg and 50 mg VSA001 at Month 10 compared to baselineThe reductions reached 86% and 89%, respectively.。Fasting serum triglyceride levels in FCS patients treated with 25 mg and 50 mg VSA001 at Month 12 compared to baselineThe reductions reached 72% and 79%, respectively.。
In the VSA001 25 mg treatment group,90% of FCS patients had fasting serum triglyceride levels drop below 500 mg/dL by the 10th month.。Serum from FCS patients treated with 25 mg and 50 mg VSA001 in the 10th monthThe median reduction of APOC3 compared to baseline reached 93% and 92%, respectively.。
FCS is a serious and extremely rare genetic disorder, typicallyCaused by multiple single-geneCaused by loss-of-function mutations.FCS typically leads to extremely elevated fasting TG levels.(Above 880 mg/dL)Severe elevation of TG can lead to various clinical diseases and serious complications, including atherosclerosis, acute pancreatitis, type 2 diabetes, and hepatic steatosis, among others.
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