--- title: "FDA clears IND application for novel anti-fibrotic drug AK3280 by ArkBio, leading to Phase 2 clinical trial for IPF." description: "On February 11, 2026, Shanghai Ark Biopharmaceutical Co., Ltd. revealed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AK3280. This dr" type: "news" locale: "en" url: "https://longbridge.com/en/news/275699696.md" published_at: "2026-02-12T04:20:54.000Z" --- # FDA clears IND application for novel anti-fibrotic drug AK3280 by ArkBio, leading to Phase 2 clinical trial for IPF. > On February 11, 2026, Shanghai Ark Biopharmaceutical Co., Ltd. revealed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AK3280. This drug is a new anti-fibrotic treatment aimed at treating idiopathic conditions. This development signifies a significant step forward in the company's efforts to introduce innovative therapies into the market. On February 11, 2026, Shanghai Ark Biopharmaceutical Co., Ltd. revealed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AK3280. This drug is a new anti-fibrotic treatment aimed at treating idiopathic conditions. This development signifies a significant step forward in the company's efforts to introduce innovative therapies into the market. ### Related Stocks - [21149.HK - 上海爱科百发生物医药技术股份有限公司](https://longbridge.com/en/quote/21149.HK.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | 23:18 ET 新型抗纤维化药物 AK3280 已获 FDA 批准,开始针对 IPF 的 2 期概念验证临床试验 | 上海阿克生物制药有限公司宣布,FDA 已批准其 AK3280 的 IND 申请,这是一种用于特发性肺纤维化(IPF)的新型抗纤维化药物。这使得阿克生物可以在美国开始第二阶段的概念验证临床试验。该试验旨在评估 AK3280 的疗效、安全性和药 | [Link](https://longbridge.com/en/news/275698481.md) | | 王炸变弃子!巨头跑路,CEO 辞职,基因疗法赛道还行不行? | 全球基因疗法行业正经历动荡。BioMarin 宣布撤回 A 型血友病基因疗法 Roctavian,Sarepta CEO Doug Ingram 辞职,反映出行业面临安全性和商业化困境。基因疗法曾是技术革命的先锋,但随着时间推移,行业气氛转 | [Link](https://longbridge.com/en/news/277038592.md) | | 太空制药–商业航天的 “新场景” | 大摩表示,可复用火箭让发射成本暴降 10 倍,医药行业或将率先跑通商业闭环。微重力环境下药物晶体纯度更高、缺陷更少,胰岛素晶体体积可达地球 34 倍。行业先行者 Varda 已完成 HIV 药物太空结晶回收,目前融资 3.28 亿美元,目标 | [Link](https://longbridge.com/en/news/276549524.md) | | Recursion Pharmaceuticals|10-K:2025 财年营收 74.68 百万美元超过预期 | | [Link](https://longbridge.com/en/news/276879117.md) | | ZAWYA-PRESSR:P4ML 成为 OTXL 的创始成员,旨在支持全球更广泛地获取超罕见疾病的治疗方法 | P4ML,一家总部位于阿联酋的 Future100 公司,已成为孤儿治疗加速器(OTXL)的创始成员,提升了对超罕见疾病治疗的获取。这一合作旨在利用 OTXL 在基因组患者识别和先进疗法方面的能力,解决超过 250 亿美元的全球先进治疗药物 | [Link](https://longbridge.com/en/news/276726002.md) | --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.