--- title: "FDA 批准了 ArkBio 公司新型抗纖維化藥物 AK3280 的 IND 申請，這將推動用於特發性肺纖維化（IPF）的二期臨牀試驗" description: "2026 年 2 月 11 日，上海阿克生物製藥有限公司透露，美國食品和藥物管理局（FDA）已批准其針對 AK3280 的臨牀試驗新藥（IND）申請。這種藥物是一種新的抗纖維化治療，旨在治療特發性疾病。這一進展標誌着公司在將創新療法推向市場方面邁出了重要一步" type: "news" locale: "zh-HK" url: "https://longbridge.com/zh-HK/news/275699696.md" published_at: "2026-02-12T04:20:54.000Z" --- # FDA 批准了 ArkBio 公司新型抗纖維化藥物 AK3280 的 IND 申請，這將推動用於特發性肺纖維化（IPF）的二期臨牀試驗 > 2026 年 2 月 11 日，上海阿克生物製藥有限公司透露，美國食品和藥物管理局（FDA）已批准其針對 AK3280 的臨牀試驗新藥（IND）申請。這種藥物是一種新的抗纖維化治療，旨在治療特發性疾病。這一進展標誌着公司在將創新療法推向市場方面邁出了重要一步 2026 年 2 月 11 日，上海阿克生物製藥有限公司透露，美國食品藥品監督管理局（FDA）已批准其針對 AK3280 的臨牀試驗新藥（IND）申請。這種藥物是一種新的抗纖維化治療，旨在治療特發性疾病。這一進展標誌着公司在將創新療法推向市場方面邁出了重要一步。 ### Related Stocks - [21149.HK - 上海愛科百發生物醫藥技術股份有限公司](https://longbridge.com/zh-HK/quote/21149.HK.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | 23:18 ETNovel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF | Shanghai Ark Biopharmaceutical Co., Ltd. announced that the FDA has cleared its IND application for AK3280, a novel anti | [Link](https://longbridge.com/zh-HK/news/275698481.md) | | FDA Launches Framework For Individualized Therapies For Ultra-Rare Diseases | The FDA has released draft guidance for approving individualized therapies for ultra-rare diseases, focusing on generati | [Link](https://longbridge.com/zh-HK/news/276727140.md) | | ZAWYA-PRESSR: P4ML becomes founding member of OTXL to support broader global access to ultra-rare disease treatments | P4ML, a UAE-based Future100 company, has become a Founding Member of the Orphan Therapeutics Accelerator (OTXL), enhanci | [Link](https://longbridge.com/zh-HK/news/276726002.md) | | enGene Maps BLA by End-2026, Targets 2027 Launch for Lead NMIBC Therapy at Oppenheimer Conference | enGene's CEO Ron Cooper presented the company's regulatory and clinical plans for its lead therapy, detalimogene vorapla | [Link](https://longbridge.com/zh-HK/news/277262258.md) | | I had serious jaw surgery — and they refused to give me pain meds | The author recounts their experience of undergoing jaw surgery and being denied opioid pain medication due to existing p | [Link](https://longbridge.com/zh-HK/news/277196235.md) | --- > **免責聲明**：本文內容僅供參考，不構成任何投資建議。