On June 13, the CDE website showed that Eli Lilly and Company submitted a new drug application for a Class 1 new drug.LY3473329 Tablets Proposed for Inclusion in Breakthrough Therapy Designation, for Use inTreatmentElevated Lp(a) Levels Associated with Confirmed Cardiovascular Disease or Increased Risk of First Cardiovascular EventAdult patients.Screenshot source: CDE official websiteLY3473329(Movabelin,Muvalaplin）Developed by Eli Lilly and CompanyOnce daily orallyOfLp(a) selective inhibitor, which can block the initial non-covalent interaction between Apo(a) and ApoB by binding to KIV7-8 of Apo(a), and inhibit the subsequent formation of disulfide bonds, ultimately preventing the assembly of Lp(a) particles without affecting the expression of Lp(a).In November 2024, Eli Lilly and Company announced the Phase II clinical study（NCT05563246）Results. The data shows,LY3473329(10 mg, 60 mg, and 240 mg)All dose groupsSignificantly reduced Lp(a) concentration, and showed明显的剂量依赖性:
Using complete Lp(a) testing,The decrease was 47.6%, respectively.（10 mg）、81.7%（60 mg）And 85.8%（240 mg）；
Using apolipoprotein(a) testing,The decrease was 40.4%, respectively.（10 mg）、70.0%（60 mg）And 68.9%（240 mg）。
In addition,The 60 mg and 240 mg doses also achieved statistically significant improvements in ApoB reduction., and there is also data showing that:
Using complete Lp(a) testing, at Week 12The percentage of subjects with Lp(a) levels below 125 nmol/L was 64.2%.（10 mg）、95.9%（60 mg）And 96.7%（240 mg）, while the placebo group was 6.0%.
Using apo(a) testing, the percentage of subjects achieving Lp(a) levels below 125 nmol/L was 38.9%.（10 mg）、81.9%（60 mg）And 77.4%（240 mg）, while the placebo group was 3.6%.
ApoB levels decreased at all doses, adjusted for placebo.The reduction rates were 8.9%, respectively.（10 mg）、13.1%（60 mg）And 16.1%（240 mg）。
Screenshot Source：Insight DatabaseLY3473329 As an oral lipid-lowering drug targeting Lp(a),Compared with traditional lipid-lowering drugs,LY3473329 The oral administration method breaks the inconvenience of injectable formulations, greatly improving patient medication adherence and making lipid-lowering treatment more convenient and efficient.。Insight database shows that currently, there are only 3Oral Lipid-Lowering Drug Targeting Lp(a) Enters Clinical Stage(Only active status is counted)，Eli LillyofLY3473329 andHengruiofHRS-5346 has entered the Phase II clinical stage,Jingxin PharmaceuticalofJX2201 is in Phase I clinical trials.'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Screenshot Source：Insight DatabaseIt is worth mentioning that, in March this year,Merck & Co. and HengruiReach an agreement on HRS-5346Exclusive License AgreementAccording to the agreement, Hengrui granted Merck an exclusive license to develop, manufacture, and commercialize HRS-5346 globally, excluding Greater China.In return, Hengrui will receive$200 millionThe initial payment, and is eligible to receive up to a maximum amount based on specific development, registration, and commercialization milestones.$1.77 billionMilestone payments. If HRS-5346 is approved, Hengrui can receive royalties based on its net sales.Cover Source:Company LogoDisclaimer:This article is for information sharing only, and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.PR Article Collaboration: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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