# United Therapeutics (UTHR) 宣布美國 FDA 已核准其源自具有 10 處基因編輯豬隻的實驗性 UHeart 進行臨床研究。

*biotech · news · 2026-05-15 · Markets Insider*

## Key points

- FDA 核准 United Therapeutics 開始其基因改造豬心臟 UHeart 的臨床試驗。
- UHeart 具有 10 處特定基因編輯，以實現人體移植。
- EXPRESS 研究將初步招募最多兩名參與者進行 UHeart 異種移植。
- FDA 對初步安全性與有效性數據的審查將決定試驗是否能進一步擴大。

United Therapeutics (UTHR) announced that the U.S. FDA has granted clearance under the company’s Investigational New Drug application to proceed with a clinical study of its investigational UHeart derived from a pig with 10 gene edits. The study, known as EXPRESS, will enroll an initial cohort of up to two participants. United Therapeutics will provide the FDA with safety and efficacy data from the first UHeart xenotransplant recipient in the study before enrolling a second participant. Following FDA review of available safety and efficacy data from the initial two transplants, the study may then be further expanded, with the intent to support a Biologics License Application with the FDA. Claim 55% Off TipRanks

**Countries:** United States

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