Iptacopan

近日礼邦公开了一篇CFB抑制剂专利WO2025237237A1，对伊普可泮（Iptacopan）进行了专利突破。该公司突破专利的策略是将伊普可泮乙氧基与哌啶环形成螺环，代表性化合物如下。 临床在研CFB抑制剂长啥样？ 星浩澎博的CFB抑制剂XH-S003是如何突破专利的 海思科的CFB抑制剂HSK39297是如何突破专利的 翰森的CFB抑制剂是如何突破专利的 聚焦 AI 药研全流程！“人工智能赋能药物研发全过程创新技术实践” 高级研修班 11月北京（中国科学院专家授课）

Otsuka secured FDA accelerated approval for its antibody drug in a disease that impacts the kidneys’ ability to filter waste. The Japanese drugmaker said late Tuesday the agency greenlit sibeprenlimab for IgA nephropathy (IgAN). The decision was based on data from a Phase 3 trial called VISIONARY in which sibeprenlimab reduced levels of protein in the urine, also known as proteinuria, by just over half versus placebo. Proteinuria is a biomarker of kidney function. Otsuka obtained the rights to sibeprenlimab during its $430 million acquisition of Visterra in 2018. The drug will be marketed as Voyxact. Pricing information wasn’t immediately available. Voyxact is the first drug of its class to clinch an approval in IgAN. It works by blocking a ligand called APRIL which is believed to drive the production of the abnormal IgA protein that builds up in the kidneys. These protein deposits damage the delicate filters that run through the kidneys, causing tissue damage and scarring. “We’re really hoping that in addition to improving symptoms, [Voyxact] will actually improve long-term kidney outcomes and has the potential for disease modification,” Otsuka chief medical officer John Kraus told Endpoints News in an interview prior to the approval. Vera Therapeutics is also advancing an APRIL-directed drug for IgAN called atacicept. The biotech has shared Phase 3 data and filed its drug for accelerated approval. Atacicept also targets a different family of ligands called BAFF. But Voyxact is arguably the more convenient option thanks to its once-monthly injection schedule, compared with atacicept’s once-weekly regimen. Meanwhile, Vertex is also advancing a dual APRIL/BAFF inhibitor called povetacicept that it says has “pipeline-in-a-product” potential. The IgAN market is already highly competitive. Novartis’ factor B inhibitor Fabhalta won accelerated approval for IgAN in August 2024, and cleared a confirmatory trial last month. In April, the Swiss company’s endothelin A receptor antagonist Vanrafia also clinched an accelerated approval for IgAN. Travere Therapeutics’ Filspari and Calliditas Therapeutics’ Tarpeyo have been on the market for some years. All four of the drugs are taken orally, which patients generally tend to prefer over injections. How well Voyxact does commercially could also depend on estimated glomerular filtration rate data from the VISIONARY study, which is expected in early 2026. This is a more robust measure of kidney function compared with proteinuria. The company says that data is intended to support traditional approval.