{"id":"8e918d40-f528-4c29-93a0-7e1ab01412ca","feedVisibility":"normal","congress":119,"billType":"hr","billNumber":7693,"title":"Leo’s Law","displayTitle":"利奥法","abstract":"利奥法 本法案将在COVID-19紧急状态期间提交申请的罕见疾病或病症药物（即孤儿药）的相关市场独占期延长180天。","displaySummary":"<p><strong>YVN Summary</strong></p>\n\n<p>开发罕见病治疗方案本已风险高、成本大，而新冠疫情更是雪上加霜——打乱了临床试验进程，延缓了研究时间表。这项名为利奥法（Leo's Law）的法案将给予孤儿药开发商（即研发罕见病治疗方案的企业）额外180天的市场独占期，以弥补因疫情造成的延误损失。这意味着仿制药或生物类似药竞争者进入市场的时间将推迟，有望激励业界持续投入往往只服务于极少数患者群体的罕见病治疗研发。</p>","status":"COMMITTEE_CONSIDERATION","topics":["HEALTHCARE"],"introducedAt":"2026-02-25T00:00:00+00:00","latestActionAt":"2026-02-25T00:00:00+00:00","congressGovUrl":"https://www.congress.gov/bill/119th-congress/house-bill/7693","accountabilityFlags":{"corporate_benefits":["↑ 孤儿药市场专营权 — 对在COVID-19紧急期间开发的药物延长180天","↑ 生物类似药专营期 — 涵盖孤儿生物制品的12年和4年窗口期延长180天","↑ 专利相关审批延迟期 — 相应的30个月及相关搁置期延长180天"],"average_household_impact":["↓ 仿制药和生物类似药上市时间表 — 涵盖罕见病药物推迟180天"]},"tldr":"为罕见病药物研发企业额外提供180天的市场独占期，以弥补疫情导致的临床试验延误。","summaryStandard":null,"flagExplainers":{},"flagValence":{},"needsResummary":false,"displaySummaryHtml":null,"rawStatusText":"Referred to the House Committee on Energy and Commerce.","chamber":"HOUSE","policyArea":"Health","legislativeSubjects":[],"lawStatus":null,"lawNumber":null,"latestActionText":"Referred to the House Committee on Energy and Commerce.","latestTextVersion":"Introduced in House","textVersionUsed":"Introduced in House","dateAdded":"2026-04-06T00:00:00+00:00","summarizedAt":"2026-04-06T00:00:00+00:00","recordId":"8e918d40-f528-4c29-93a0-7e1ab01412ca","feedIdentityKey":"119/hr/7693","websiteBillId":"HR-7693","yourvoiceSummary":"开发罕见病治疗方案本已风险高、成本大，而新冠疫情更是雪上加霜——打乱了临床试验进程，延缓了研究时间表。这项名为利奥法（Leo's Law）的法案将给予孤儿药开发商（即研发罕见病治疗方案的企业）额外180天的市场独占期，以弥补因疫情造成的延误损失。这意味着仿制药或生物类似药竞争者进入市场的时间将推迟，有望激励业界持续投入往往只服务于极少数患者群体的罕见病治疗研发。","updatedAt":"2026-10-25T02:22:02.450313+00:00"}