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  <title>李一青医药产业观点</title>
  <id>https://stevenyiqingli.com/zh/insights/</id>
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  <updated>2026-07-20T00:00:00Z</updated>
  <entry>
    <title>在东南亚建立可持续医药合作</title>
    <id>https://stevenyiqingli.com/zh/insights/sustainable-pharma-partnerships-southeast-asia.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/sustainable-pharma-partnerships-southeast-asia.html" />
    <published>2026-07-19T00:00:00Z</published>
    <updated>2026-07-19T00:00:00Z</updated>
    <summary>从市场、注册、技术、质量与商务五个维度，构建东南亚医药合作的阶段闸门框架。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>以技术转移推动本地化生产</title>
    <id>https://stevenyiqingli.com/zh/insights/technology-transfer-localized-manufacturing.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/technology-transfer-localized-manufacturing.html" />
    <published>2026-07-19T00:00:00Z</published>
    <updated>2026-07-19T00:00:00Z</updated>
    <summary>以全生命周期方法推进制药技术转移、工艺放大、验证与接收方能力建设。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>以质量体系筑牢跨境医药合作基础</title>
    <id>https://stevenyiqingli.com/zh/insights/quality-systems-cross-border-partnerships.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/quality-systems-cross-border-partnerships.html" />
    <published>2026-07-19T00:00:00Z</published>
    <updated>2026-07-19T00:00:00Z</updated>
    <summary>以清晰的质量治理、证据体系和变更控制支持可持续的跨境医药合作。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>无菌注射剂CMO/CDMO项目评估</title>
    <id>https://stevenyiqingli.com/zh/insights/sterile-injectable-cmo-cdmo-project-evaluation.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/sterile-injectable-cmo-cdmo-project-evaluation.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>从非保密适配筛选到技术转移、验证与商业化准备的阶段化项目路径。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>CMO、CDMO还是技术转移？医药合作模式选择框架</title>
    <id>https://stevenyiqingli.com/zh/insights/cmo-cdmo-technology-transfer-selection.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/cmo-cdmo-technology-transfer-selection.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>根据产品成熟度、证据缺口、注册责任和项目终态，选择CMO、CDMO或技术转移合作模式。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>药品委托生产质量协议应明确哪些责任？</title>
    <id>https://stevenyiqingli.com/zh/insights/pharmaceutical-quality-agreement-responsibilities.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/pharmaceutical-quality-agreement-responsibilities.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>将质量治理、放行、变更、调查、记录、审计和全生命周期管理转化为可执行责任矩阵。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>CMO/CDMO项目初评需要准备哪些非保密资料？</title>
    <id>https://stevenyiqingli.com/zh/insights/cmo-cdmo-preliminary-assessment-nonconfidential-information.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/cmo-cdmo-preliminary-assessment-nonconfidential-information.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>在披露敏感技术信息前，用一页非保密事实安全判断项目适配度。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>如何评估无菌制剂受托生产企业？</title>
    <id>https://stevenyiqingli.com/zh/insights/evaluating-sterile-pharmaceutical-contract-manufacturer.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/evaluating-sterile-pharmaceutical-contract-manufacturer.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>围绕无菌保证、场地适配、质量体系、证据和供应韧性的现场尽调框架。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
  <entry>
    <title>海外药企选择中国制药合作伙伴的尽调清单</title>
    <id>https://stevenyiqingli.com/zh/insights/due-diligence-chinese-pharmaceutical-manufacturing-partner.html</id>
    <link href="https://stevenyiqingli.com/zh/insights/due-diligence-chinese-pharmaceutical-manufacturing-partner.html" />
    <published>2026-07-20T00:00:00Z</published>
    <updated>2026-07-20T00:00:00Z</updated>
    <summary>从公开记录到现场审查，分阶段核验中国制药合作主体、场地、产品和市场适配。</summary>
    <author><name>Steven Li (李一青)</name></author>
  </entry>
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