Fentanyl Citrate

在医药行业全球化纵深发展、地缘政治博弈加剧及监管环境日趋复杂的背景下，中国生物医药企业积极拓展海外市场、寻求跨境合作已成为寻求突破与可持续发展的关键路径之一。 然而，伴随美国近期在生物安全、敏感个人数据出境监管、外商投资审查及关税政策等领域密集出台一系列针对中国企业的法律法规，中美间生物医药领域的跨境BD(Business Development)交易正面临前所未有的系统性挑战与合规压力。这些政策深刻影响着BD交易结构设计、交易文件条款草拟和审阅、项目的估值谈判、供应链布局乃至资金流动等核心环节。 考虑到美国上述政策的多维度、深层次影响对中美跨境BD交易构成显著制约并增加不确定性，为助力中国生物医药企业有效识别风险、把握机遇、实现合作合规，本文将首先对美国近期关键生物医药政策(包括《生物安全法案》立法动态、敏感个人数据出境新规、美国食品药品监督管理局(“FDA”)特定临床试验禁令、美国外商投资限制及关税政策)的核心内容与监管要点进行系统梳理与总结。 在此基础上，聚焦于跨境BD交易全流程，结合具体业务场景，在对应政策下，分别为中国生物医药企业提供具有实操性的合规应对策略与建议，以期为企业跨越政策壁垒、实现稳健的国际合作提供参考。 美国近期生物医药相关政策 对中美跨境BD交易的影响及合规建议 01 美国生物安全法案 1、美国生物安全法案监管概况 截至目前1，美国《生物安全法案》的草案已通过美国参议院、众议院两院批准，其中，美国参议院批准的版本为S.3558号法案“Prohibiting Foreign Access to American Genetic Information Act of 2024”2(“参议院版本”)，众议院批准的版本为H.R.8333号法案“BIOSECURE Act”3(“众议院版本”)，参议院版本与众议院版本在实质内容上没有重大差异。 此前预计《生物安全法案》将通过纳入2024年年底审议的2025财年国防授权法案“National Defense Authorization Act for Fiscal Year 2025”(“2025 NDAA”)的方式，通过国防立法快捷通道生效，但是该快速立法的计划没有实际实施。因此，目前《生物安全法案》尚未生效。 尽管如此，《生物安全法案》成为生效法律的威胁仍旧存在，其仍可能通过单独立法的方式推进，且鉴于初稿已分别通过参议院、众议院的审核，对中国生物医药企业进行限制已成为美国政界的共识，《生物安全法案》最终生效的可能性较大。 由此，对于相关企业而言，需注意《生物安全法案》拟建立的监管框架，密切关注其立法进展动态，以及评估其生效对于现有业务及其连续性等方面可能带来的影响。 2、美国生物安全法案监管要点 就最新《生物安全法案》的监管框架设计，参议院版本与众议院版本均明确禁止美国行政机构(executive agencies)采购或获取由“受关注生物技术公司(a biotechnology company of concern)”制造或提供的生物技术设备或服务(biotechnology equipment or service)，并延伸禁止签订、续订任何涉及使用该等设备或服务的合同。同时，《生物安全法案》切断了联邦资金链，其规定美国行政机构不得将贷款或拨款资金用于相关交易，接受联邦资金的主体亦不得与受关注生物技术公司开展相关交易。 由此可见，在判断某项行为或者活动是否需要受到《生物医药法案》的调整，主要有两大考量因素：其一，相关主体是否被认定为受关注生物技术公司，其二，是否涉及或者归类为该法案所定义的禁止性行为。需要特别注意的是，目前《生物医药法案》已明确列举的受关注生物技术公司包括药明康德(WuXi AppTec)、华大基因(BGI)、华大智造(MGI)、Complete Genomics(华大智造子公司)、WuXi Biologics(药明生物)及其关联实体。 此外，该《生物医药法案》还授权美国行政管理预算局(The Office of Management and Budget，OMB)联合相关部门，动态制定受关注生物技术公司的实体清单。因此，受关注生物技术公司将会根据OMB更新的实体清单动态调整。 (1)受关注生物技术公司的认定标准 就受关注生物技术公司的范围4，除了上述明确列举的药明康德、华大基因等主体外，还包括美国政府新增认定同时满足如下要件的实体： (a)受外国对手(包括中国、俄罗斯、伊朗和朝鲜)管辖、控制或代其行事；值得关注的是，参议院和众议院两院的法案版本中，对前述要件中“管辖”的法律表述存在差异：参议院版本采用“jurisdiction”的表述，而众议院版本采用“administrative governance structure”，前者可能涵盖更广泛的政府关联形式，如存在国有资本控制或接受政府指令等，即使从政府机构组织架构而言没有从属关系； (b)该实体在任何程度上参与生物技术设备或服务的制造、分销、提供或采购活动； (c）该实体行为须基于特定活动威胁美国国家安全，前述特定活动具体包括三类情形：(i)与外国对手的军事力量、内部安全部队或情报机构进行联合研究或存在支持或关联关系；(ii)将通过生物技术设备或服务获取的人类多组学数据提供给外国政府；或(iii)在未获得明确知情同意的情况下通过生物技术设备或服务收集人类多组学数据。 (2)禁止性行为的法律边界 《生物安全法案》5拟构建如下三层禁止性行为体系： 第一层为直接采购禁令，规定美国行政机构不得获取或采购受关注生物技术公司生产或提供的生物技术设备或服务； 第二层为间接合作禁令，禁止美国行政机构签订、续订任何涉及使用，或有合理理由认为将会使用，受关注生物技术公司生产或提供的生物技术设备或服务的合同； 第三层为资金链限制，禁止美国行政机构或接受联邦资金的机构，使用联邦贷款或拨款资金获取或采购受关注生物技术公司生产或提供的生物技术设备或服务，或签订、续订涉及前述交易的任何合同。 值得注意的是，上述三层禁止性行为体系中提及的“生物技术设备或服务”，其范围6非常广泛，具体包括： (a)设备，包括基因测序仪、质谱仪、聚合酶链式反应机器或任何其他仪器、设备、机器或装置，包括其组件和配件，设计用于生物材料的研究、开发、生产或分析，以及任何专门设计用于此类设备操作所需的软件、固件或其他数字组件； (b)任何用于与生物材料相关的研究、开发、生产、分析、检测或信息提供的服务，包括数据存储和传输服务，其中包括：(i)关于使用或实施(a)项所述仪器、设备、机器或装置的建议、咨询或支持服务；及(ii)疾病检测、家族遗传信息及相关服务；以及 (c)由相关政府部门负责人为保护国家安全之目的协商后认为适当的任何其他服务、仪器、设备、机器、组件、配件、装置、软件或固件。 3、美国生物安全法案合规建议 (1)供应商风险审查 虽然美国《生物安全法案》对中美跨境BD没有直接的影响，但考虑到《生物安全法案》限制的生物技术设备或服务范围非常广泛，包括CRO等医药研发过程中的核心服务。因此，如相关供应商被认定为受关注生物技术公司，则可能会对医药研发产生重大负面影响，进而影响中国生物医药企业的管线价值。基于此，笔者倾向于建议生物医药企业开展如下供应商风险审查： 第一，确认目前生物技术设备或服务供应商是否属于“受关注生物技术公司”。除被美国《生物安全法案》明确列入名单的实体及其关联实体外，也应当谨慎审查具有国资背景的中国供应商。 第二，确认本公司业务与美国联邦政府的关联度，包括公司是否直接/间接为美国联邦政府提供服务，是否直接/间接接受美国联邦政府补贴或者资金资助。 第三，如存在生物技术设备或服务供应商被认定为“受关注生物技术公司”的风险，则公司应当积极寻找替代供应商，并评估替代供应商的切换周期。 此外，笔者倾向于建议企业持续关注美国《生物安全法案》以及相关实施细则的出台，并及时做出应对。 (2)供应商合同重要条款评估 美国《生物安全法案》的发布(尽管没有生效)预示着医药行业供应链的稳定性将越来越受到国际政治博弈的影响。因此，笔者倾向于建议生物医药企业重点审查供应商合同中如下重要条款： 第一，终止权条款：审查供应商合同中是否有政府禁令触发无条件解约的条款，以及相关条款的可执行性； 第二，技术移交保障：要求供应商在解约时免费移交完整的研究成果、实验数据、资料等，并确保公司对此享有完整的知识产权。 02 美国敏感个人数据出境 1、美国敏感个人数据出境监管概况 2024年2月28日，拜登政府签发第14117号行政命令 “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern”(“14117号行政命令”）7，认定中国、俄罗斯等受关注国家及受监管主体通过获取美国公民敏感个人数据(Sensitive Personal Data)已构成国家安全威胁，要求美国司法部制定配套实施规则限制受关注国家(Countries of Concern)及受监管主体(Covered Person)获取美国公民批量敏感个人数据(Bulk U.S. Sensitive Personal Data)。 2025年4月8日，美国司法部相应制定的14117号行政命令的配套实施细则“Preventing Access to U.S. Sensitive Personal Data and Government-Related Data By Countries of Concern or Covered Persons”(“《最终规则》”)8生效。 2、美国敏感个人数据出境监管要点 (1)敏感个人数据的定义以及批量数据的标准 “敏感个人数据”涵盖受监管个人标识符(Covered Personal Identifiers)、精确地理位置数据(Precise Geolocation Data)、生物识别符(Biometric Identifiers)、人类“组学数据”(Human 'Omic Data)、个人健康数据(Personal Health Data)等六类信息及其组合9。 “批量”(Bulk)的认定标准10指在过去的12个月内，任何敏感个人数据的数量达到或超过一定阈值，无论是通过单次受监管数据交易，还是通过涉及同一美国个人与同一外国主体或受监管主体的多次数据交易。 关于敏感个人数据的具体定义及对应类型数据达到“批量”标准的阈值总结如下： 此外，以下数据不属于敏感个人数据的范畴12： (a)与个人无关的公共或非公共数据，包括商业秘密、专有信息； (b)在交易时，通过联邦、州或地方政府记录(例如法院记录)或广泛传播的媒体合法公开可用的数据； (c)个人通信；以及  (d)信息或信息材料以及通常相关的元数据，或为实现此类信息或信息材料的传输或传播合理必要的元数据。 (2)受关注国家及受监管主体 “受关注国家”包括中国(含香港、澳门特别行政区)、古巴、伊朗、朝鲜、俄罗斯、委内瑞拉13。 “受监管主体”包括14： (a)在受关注国家成立/或主要经营地址在受关注国家的公司，以及受关注国家和本条(b)项所列主体直接/间接、单独/共同控股50%以上的境外主体； (b)本条(a)、(c)、(d)、(e)项所列主体直接/间接、单独/共同控股50%以上的境外主体； (c）本条(a)、(b)、(e)项所列主体的雇员/合同工； (d）主要居住在受关注国家辖区内的境外个人；以及 (e）美国司法部官员认定可能为受关注国家/受监管主体控制，或为其行事的主体。 (3)具体监管措施 除非获得许可或豁免，禁止或限制美国主体与受关注国家或受监管主体进行受监管数据交易(covered data transaction)；受监管数据交易是指涉及受关注国家或受监管主体访问任何批量美国敏感个人数据，并且包括以下之一的任何交易：(a)数据经纪；(b)供应商协议；(c)雇佣协议；或(d)投资协议15。 3、美国敏感个人数据出境合规建议 (1)辨别项目涉及的数据的类型 笔者倾向于建议生物医药企业在开展多中心临床试验或跨境技术交易等项目前，辨别该项目涉及的数据类型以及是否属于受到监管的数据，以更好遵守监管要求。 若跨境技术交易的内容为临床前阶段的化学药技术，则一般仅涉及临床前研究数据，例如药理毒理研究数据、动物试验研究数据等，因此受到对应监管的可能性也较小。相反，若跨境技术交易的内容已处于临床试验阶段或拟开展包括美国在内的多中心临床试验，由于临床试验是以人体(患者或健康受试者)为对象的试验16，笔者倾向于认为，其有很大可能涉及敏感个人信息，因而受到美国个人敏感数据出境的监管。 (2)项目开展前明确所涉数据是否涉及出境 在确定项目所涉及的数据类型后，笔者倾向于建议各生物医药企业进一步明确所欲开展的项目是否涉及从美国出境到中国。如若涉及，则笔者倾向于建议对应了解此种数据类型在美国的跨境传输监管要求，确认是否符合豁免的情形，以办理相应审批、备案手续或履行安全评估等行政程序，建立相应的数据安全体系以及采取必要数据安全措施等。 (3)在项目交易文件中明确数据跨境传输的合规要求及各方需履行的义务 笔者倾向于建议各生物医药企业建立内部数据跨境传输合规管理制度和管理机制，以及完善内部数据安全体系建设；如涉及跨境技术交易项目的，则在交易文件中明确交易所涉数据跨境传输的具体合规要求，并以此进一步明确交易各方所需履行的义务内容，从而保证交易的整体合规性。否则，生物医药企业将可能面临不同程度的法律风险，乃至面临数据被销毁等制裁和/或处罚措施。 以国内生物医药企业引进美国的医药技术为例，若涉及大量敏感个人数据的，一方面，笔者倾向于建议Licensee在交易文件中明确要求Licensor履行美国对于敏感个人信息出境到中国的监管要求，包括行政程序和内部数据安全体系建设，保证交易不存在数据跨境传输方面的障碍。另一方面，笔者倾向于建议要求Licensor应对取得数据权利主体的知情同意，以及通过伦理审查等作出相应的陈述与保证。 (4)持续关注中美数据跨境传输的监管动态和监管新规 近年来，美国对于美国公民个人数据跨境传输至中国的监管力度不断加大，相关新规的出台较为频繁。为减少因数据跨境传输问题导致项目开展受到阻碍或失败，笔者倾向于建议国内生物医药企业持续关注中美数据跨境传输领域的监管动态以及执法动态，对应完善自身及项目所涉的政府监管程序和/或审批、备案手续，调整商业模式和策略，以保证项目的顺利开展和合规长效执行。 03 FDA叫停将美国公民的细胞出口到中国实验室以进行基因工程研究的临床试验 1、FDA临床试验禁令监管概览和要点 2025年6月18日，FDA宣布立即暂停所有涉及将美国公民活体细胞转运至中国等敌对国家进行基因工程研究，并后续回输至美国患者的新临床试验17(“FDA临床试验禁令”)。 此项禁令发布的背景系FDA发现部分相关临床试验未能告知临床试验受试者其生物材料将涉及跨境传输及人为操纵的情况，并可能导致美国公民的敏感基因数据面临被外国政府(尤其是敌对国家)不当使用的风险。FDA认为，前述违规行为的产生系源于《最终规则》中的一项豁免规定：虽然向受关注国家转移敏感数据的行为总体上受到限制，但美国公司被允许将临床试验受试者的生物样本(包括DNA)转移到海外进行处理，并作为 FDA监管的临床试验的一部分；该豁免在实践中存在被滥用的情况，甚至实际适用于涉及中国共产党部分拥有或控制公司的临床试验。 基于此，FDA正在积极审查适用上述豁免的所有相关临床试验，并且要求相关公司证明完全透明、伦理同意以及敏感生物材料的境内处理。无法符合前述标准的新申请临床试验将不会被推进。同时，FDA也在与美国国家卫生研究院(NIH)建立联合审查机制，以保证没有联邦资金支持的研究包含FDA临床试验禁令所禁止的行为。后续将出台更多实施细则。 2、FDA临床试验禁令应对合规建议 (1)涉美临床试验项目核查 笔者倾向于建议生物医药企业全面核查涉美在研临床试验项目(如开展国际多中心临床试验、与美国实体在CGT领域合作开发等)的生物样本跨境传输路径，重点识别是否涉及将美国公民的活体细胞转运至中国进行基因工程研究，并后续回输至美国患者的情况。若存在相关情形，相关临床试验可能会面临被FDA叫停的风险。 对于其他涉及将美国公民的生物样本(包括DNA)转移到中国处理的临床试验，笔者倾向于建议企业重点核查知情同意文件是否完整签署，确保美国受试者明确授权其生物样本跨境传输及基因编辑操作(如CAR-T细胞境外改造)，可以在知情同意文件中补充跨境风险专项告知条款等。 (2)FDA临床试验禁令的应对措施 第一，生物样本处理本地化 笔者倾向于建议，生物医药企业避免将美国公民活体细胞跨境转运至中国，并将基因编辑、测序等核心环节转移至美国境内FDA认可的机构，以不会影响和阻碍临床试验和药物研发注册进度。 第二，合同中明确合规要求及各方义务 对于涉及利用美国公民生物样本进行临床试验的项目，笔者倾向于建议生物医药企业重点关注如下合同条款，明确合规要求： (a)要求相关方承诺美国公民的敏感生物材料不在中国境内处理，明确可代替方案和执行要求，如果违约将触发另一方的合同终止权并有权要求惩罚性赔偿； (b)要求相关方对临床试验通过伦理审批、完整取得美国受试者的知情同意作出陈述与保证，并须提供经伦理委员会批准的知情同意文件模板，并保存美国受试者实际签署的知情同意文件备查。 04 验美国外商投资限制 1、美国外商投资监管概览 自2018年美国总统特朗普上台后，美国持续加强投资领域对中国资本的限制，相关已生效法律法规汇总如下： 除了以上已经生效的法律法规，2025年2月21日，美国总统特朗普签署了《美国优先投资政策》(America First Investment Policy)备忘录(“备忘录”)22，旨在进一步限制中国等敌对国家对美国企业和关键技术(包括生物医药领域)的投资，加强相关投资审查。尽管备忘录本身不直接设立新的法规，但指示相关行政机关启动立法程序以落实备忘录提出的监管原则。 2、美国外商投资监管重点 (1)受监管投资(covered investment) CFIUS有权审查满足如下标准的受监管投资(covered investment)23：外国投资者对从事TID(关键技术、关键基础设施、敏感个人数据)业务的美国企业的投资，且通过该等投资获得下述任何一项权利：有权获得美国企业掌握的“重大非公开技术信息”(material nonpublic technical information)；有权提名美国企业的董事或董事会观察员；可通过行使投票权以外的方式参与美国企业的“实质性决策”(substantive decision-making)。 对于上述受监管投资，除以下投资需要进行强制申报(mandatory declaration)，其余的为自愿申报(voluntary declaration)24： (a)外国投资者取得从事TID业务的美国企业的实质性权益(25%或以上投票权)，且政府实体在该外国投资者中拥有实质性权益(49%或以上投票权)25； (b)涉及从事关键技术(T)业务的美国企业，且该等关键技术出口或转让给特定的外国投资者需要美国监管机构授权(主要是出口管制)，以及在该等外国投资者中拥有25%或以上投票权的外国主体也需要进行强制申报26。  (2)美国外商投资监管发展趋势 就中国对美国的投资，美国政府将使用各种法律手段(包括CFIUS)强化对来自中国等“外国对手”在美投资的审查，特别是在医疗健康等战略性领域27。尤其值得关注的是，CFIUS的权限将进一步扩大，其审查范围不仅涵盖传统的并购交易，也可能延伸至“绿地投资(greenfield)”，以达到限制外国对手获取美国在敏感技术领域的人才和运营资源的目的，并将扩大CFIUS可审查的“新兴和基础(emerging and foundational)”技术范围。 就美国对中国的投资，美国政府也计划在对外投资方面对中国采取更严格的限制28，重点针对生物技术等与中国“军民融合”战略相关的产业。这些限制可能适用于私募股权、风险投资、绿地投资、公司扩张、上市证券投资等多种投资形式，涵盖对象包括养老金、大学捐赠基金等机构投资者。 3、美国外商投资政策的影响及合规建议 当前，美国在生物医药等关键领域投资对中国的限制措施持续强化，中国资本投资美国生物技术企业面临的不确定性陡增，审查趋严一定程度上已成定局；与此同时，美国资本进入中国相关领域也遭遇更多阻碍。这种双向收紧态势，无疑对中美技术合作、交易活动及资金流动构成深远挑战。 鉴于此，笔者倾向于建议中国生物医药企业采取如下积极主动的应对策略，尤其对于涉及股权交易的NewCo交易模式： 第一，系统性地评估和管控美国外商投资限制风险。任何涉及美国资产、技术或业务的投资计划，尤其是与美国主体合作设立NewCo的项目，均需在早期阶段引入专业的法律顾问，深入分析交易结构潜在触发CFIUS审查的可能性，并预先制定详尽的应对预案，包括准备申报材料、评估强制申报必要性等。 第二，加速推进融资渠道的多元化战略。中国生物医药企业可着力开拓非美国资金来源，积极寻求欧洲、亚洲及其他地区国际资本市场的机会，同时大力挖掘和深化国内资本市场的潜力，分散对单一市场(尤其是美国)融资的依赖，以有效缓解美国政策突变带来的冲击。 最后，在有效生存和发展的基础上，积极探索其他非美国主导的国际合作与投资机会。在战略布局上，中国生物医药企业可考虑将研发、生产的重心适度向政策环境更为友好或稳定的区域调整，构建更具韧性的全球布局。 05 美国关税限制 1、美国关税政策概览 2025年4月2日，美国政府依据14257号总统行政令29，对中国出口至美国的商品加征34%的“对等关税(Reciprocal Tariff)”，14257号总统行政令附件II对大部分药品、生物制品实施关税豁免，范围包括化药制剂、疫苗、抗体等，但对医疗器械与耗材，如注射器、针头、医用手套等商品，仍保留完全征税不在关税豁免的范围内。 2025年4月8日，美国政府依据14259号总统行政令30对中国出口至美国的商品加征追加50%关税，使综合税率升至104%。 2025年4月9日，美国政府依据14266号总统行政令31宣布关税上调至125%并即时生效(叠加2025年2-3月芬太尼20%附加关税后达145%)。 2025年5月12日，中美双方发布《中美日内瓦经贸会谈联合声明》32，其中美国达成阶段性妥协如下：将(一)修改2025年4月2日第14257号行政令中规定的对中国商品加征的从价关税，其中，24%的关税在初始的90天内暂停实施，同时保留按该行政令的规定对这些商品加征剩余10%的关税；(二)取消根据2025年4月8日第14259号行政令和2025年4月9日第14266号行政令对这些商品的加征关税。 2、美国关税政策对跨境BD交易的影响 美国关税政策系针对实体商品流通环节设计，而大多数生物医药跨境BD交易的本质为知识产权许可交易而非实物商品贸易，其核心标的为专利、专有技术等无形资产，其许可费支付及技术文档传输目前不受关税机制约束。 因此，当前美国关税政策对生物医药跨境BD交易影响有限。但是，不排除美国政府后续会出台相应针对相关技术跨境BD交易的相关限制政策。 3、美国关税限制应对建议 虽然当前美国关税政策对生物医药跨境BD交易本身的影响相对有限，但是这并不意味着相关企业可以忽视关税环境变化带来的间接冲击与战略挑战。 笔者倾向于认为，关税政策波动可能对License-out交易中的财务条款(尤其是首付款与里程碑支付)产生间接影响。其传导逻辑在于：关税增加抬高了未来创新药实体贸易的成本，促使美国授权方(Licensee)在谈判中更为审慎地评估交易价值。例如，中国药企将创新药技术授权给美国合作方时，后者可能因预期到未来因关税导致的药品生产成本和销售价格上升、潜在市场需求受压，而要求降低首付款金额，或在里程碑条款中设定更高的销售目标门槛、降低支付金额，以对冲其成本上升和市场风险。这种基于关税成本传导的议价压力，可能间接影响中国生物医药企业的短期现金流入和长期收益预期。 笔者倾向于认为，更深远的影响体现在全球供应链布局与市场战略层面。为降低对单一美国市场的依赖及规避关税风险，笔者倾向于建议中国生物医药企业考虑积极调整产业布局，加速供应链多元化： 对于已有美国业务的企业，可考虑利用其美国实体进行战略性的产品储备；同时，应当积极在低关税国家或区域投资设立符合当地严格监管要求的生产基地，并通过当地的GMP认证。尽管这一过程涉及高昂的初期投入(包括建厂、认证、应对海外运营成本上升)，并带来短期成本增加与产能调整的挑战，但从长远看，实现多地域生产能有效分散地缘政治风险，显著增强供应链韧性与市场响应能力，其战略必要性毋庸置疑。 在有效兼顾生存和发展的基础上，主动拓展非美国市场，提升在欧洲、日本等市场的影响力，并积极开拓新兴市场，以多元化市场结构稀释美国关税政策的负面影响。笔者相信，更具韧性的全球产业布局也将提高中国生物医药企业管线在跨境BD交易中的价值。 最后，笔者倾向于建议生物医药企业建立动态的关税政策监测与应对机制。密切关注美国及相关国家关税政策的调整动向，及时评估其对货物贸易供应链成本和BD交易环境的潜在影响，以便快速调整供应链策略和商业谈判策略。 — 总结和展望 —   面对美国近期密集出台且持续演变的生物医药领域监管政策，中国生物医药企业在中美跨境BD交易中正经历前所未有的合规风险挑战。 本文系统梳理了生物安全法案立法动态、敏感个人数据出境新规、FDA特定临床试验禁令、外商投资审查及关税政策等关键政策的核心要点及中国生物医药企业的合规应对策略。然而，合规风险的边界远不止于此，中国生物医药企业也应当关注其他关键风险领域的合规要求，如：跨境税务合规、生物制品进出口监管、出口管制与经济制裁等。 从长远发展的视野看，合规是跨境BD交易得以顺利完成和推进后续落地执行的重要基石。中国生物医药企业唯有树立全局性、前瞻性的合规意识，构建覆盖全链条、多领域的动态风险管理体系，方能在中美政策博弈的复杂环境中有效识别风险、把握机遇、稳健前行。 笔者倾向于建议，在中国生物医药企业商业可行的情形下，设立专职合规人员或者指定专门岗位，持续跟踪中美及目标市场的最新法规动态与执法案例；在跨境BD交易的早期阶段即引入法律、税务、政府监管事务专家，进行全面的合规尽职调查与项目风险评估；在跨境BD交易过程中，将合规要求深度嵌入BD交易模式设计、交易文件谈判及日常运营，确保业务拓展的可持续性。 笔者也将持续关注中美相关监管政策的出台及执法口径的变化，以期为中国生物医药企业的出海和国际化发展保驾护航。 本文作者：刘婷婷 黄冠鸿 张妍 作者简介 刘婷婷 （上下滑动查看更多） 刘婷婷律师是上海市锦天城律师事务所合伙人律师，现为中国生物医药产业链创新与转化联合体(CBIITA联合体)商务拓展专委会副主委等。刘律师被知名法律评级机构LEGALBAND评为2023年度中国律界俊杰三十强，刘律师还被国际权威法律评级机构《The Legal 500》评为2024年中国大陆生命科学与大健康领域重点推荐律师。 刘婷婷律师自执业以来精耕于生命科学和医药健康领域，主要为跨国药械企业(包括但不限于阿斯利康、雅培、西门子医疗、默沙东、勃林格殷格翰、罗氏、百济神州、爱施健、美纳里尼、石药集团、天境生物、康哲药业、贝达药业、万泰生物、英派药业、鞍石生物等)、医疗机构(包括但不限于国内首家外资三甲综合性医院和顶级公立三甲医院)、医疗(生)集团、互联网医疗健康企业、保险公司以及专投医疗药械项目的专业基金公司等企业机构提供境内外投融资并购、跨境药械技术交易和合作、监管合规、争议解决及公司日常等法律服务，包括协助国内外多家知名药企开展多个跨境License in/out技术交易和合作开发项目等。 刘婷婷律师毕业于华东政法大学，在中国医药报、上海律协、威科先行、LexisNexis、E药经理人等专业法律和医药行业平台发表医药健康领域法律实务总结文章和报告近百篇，包括但不限于：《医药企业技术交易实务系列文章(合辑)》(中英文版本，2023年，联合E药经理人发布)；《医疗机构新设并购及合规管理实务手册》(2023年，联合威科先行法律数据库发布)；《医药行业行政处罚风险提示与防范解析报告》(2020年，联合威科先行法律数据库发布)；《医疗AI法律及监管报告》行业发展与现状和医疗AI产品责任章节(2019年，联合腾讯健康发布，国内首份医疗AI法律研究报告)等。 联系电话：15216738527（同微信） 联系邮箱：tinaliu@allbrightlaw.com 黄冠鸿 （上下滑动查看更多） 黄冠鸿律师是上海市锦天城律师事务所资深律师、国际公认反洗钱师(CAMS)，企业合规师(高级)。 黄冠鸿律师自执业以来，专注在金融监管、风险与内控管理、生命大健康等领域的法律服务。在医疗药械常法、合规融资交易业务领域，黄律师曾服务的客户包括但不限于罗氏诊断、美纳里尼、石药集团、康哲药业、贝达药业、万泰生物、英派药业、嘉和美康、鞍石生物、祥耀生物、思勤医疗、勤浩医药、逻晟生物、帝奇医药、子瞻生物、纽安津生物、迈诺威医药、霖鼎光学、森世海亚集团、阳光医疗集团、哈特瑞姆心脏医疗集团、上海联影集团等医疗药械企业，为他们提供的法律服务范围涵盖企业日常事务、研发及临床、运营和数据合规、境内外投资、股权融资及跨境BD交易等方面的法律服务。 黄冠鸿律师毕业于华东政法大学，同时获得法学学士、经济学(金融方向)学士学位。 联系电话：18817836896（同微信） 联系邮箱：hgh@allbrightlaw.com 张妍 张妍律师是上海市锦天城律师事务所律师助理。张妍律师毕业于华东政法大学, 获得法学学士及法学硕士学位；并于美国纽约大学法学院获得法学硕士学位。张妍律师曾在知名国际律所及国内律所投融资并购团队长期实习和工作。张妍律师主要就医疗健康和医药、投融资、M&A及公司合规提供法律服务。 参考文献：（上下滑动查看更多） 1. 2025年7月22日。2. https://www.congress.gov/bill/118th-congress/senate-bill/3558/text。  3. https://www.congress.gov/bill/118th-congress/house-bill/8333/all-actions。 4 .参议院版本以及众议院版本第2条(f)项。 5. 参议院版本以及众议院版本第2条。 6. 参议院版本以及众议院版本第2条(k)(2)项。 7. https://www.federalregister.gov/documents/2024/03/01/2024-04573/preventing-access-to-americans-bulk-sensitive-personal-data-and-united-states-government-related。  8. https://www.federalregister.gov/documents/2025/01/08/2024-31486/preventing-access-to-us-sensitive-personal-data-and-government-related-data-by-countries-of-concern。 9. 《最终规则》§202.249条。 10. 《最终规则》§202.205条。 11. listed identifier，指政府身份证明或账户号码、与金融机构相关的财务账户号码或个人识别号码、基于设备或硬件的标识符、人口统计或联系数据、广告标识符、账户认证数据、基于网络的标识符、通话详情数据。 12. 《最终规则》§ 202.249条。 13. 《最终规则》§202.601条。 14. 《最终规则》§ 202.211条。 15. 《最终规则》第C、D部分。 16. 《药物临床试验质量管理规范》第11条。 17. https://www.fda.gov/news-events/press-announcements/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic。  18. https://home.treasury.gov/sites/default/files/2018-08/The-Foreign-Investment-Risk-Review-Modernization-Act-of-2018-FIRRMA_0.pdf。 19. https://home.treasury.gov/system/files/206/Part-800-Final-Rule-Jan-17-2020.pdf。  20. https://home.treasury.gov/system/files/206/Part-802-Final-Rule-Jan-17-2020.pdf。  21. https://www.govinfo.gov/content/pkg/FR-2022-09-20/pdf/2022-20450.pdf。  22. https://www.whitehouse.gov/presidential-actions/2025/02/america-first-investment-policy/。 23. 31 C.F.R Part 800第211条。 24. 31 C.F.R Part 800第402条。 25. 31 C.F.R Part 800第401(b)条。 26. 31 C.F.R Part 800 第401(c)条。 27. 备忘录第2(f)条。 28. 备忘录第2(j)条。 29. https://public-inspection.federalregister.gov/2025-06063.pdf。 30. https://www.whitehouse.gov/presidential-actions/2025/04/amendment-to-recipricol-tariffs-and-updated-duties-as-applied-to-low-value-imports-from-the-peoples-republic-of-china/。 31. https://www.whitehouse.gov/presidential-actions/2025/04/modifying-reciprocal-tariff-rates-to-reflect-trading-partner-retaliation-and-alignment/。  32. https://www.gov.cn/yaowen/liebiao/202505/content_7023399.htm。 英译版（上下滑动查看更多) Impacts of Recent U.S. Pharmaceutical Policies on China-U.S. Cross-Border BD Transactions and Compliance Recommendations TONACEA 01 Introduction Under the background of deepening globalization in the pharmaceutical industry, intensifying geopolitical tensions, and an increasingly complex regulatory environment, Chinese pharmaceutical companies are actively expanding into overseas markets and seeking cross-border collaborations as a key pathway to breakthroughs and sustainable development. However, with the recent proliferation of U.S. laws and regulations specifically targeting Chinese enterprises—across areas such as biosecurity, outbound transfers of sensitive personal data, foreign investment restriction, and tariff policy—cross-border business development (BD) transactions in the pharmaceutical sector between China and the United States are now facing unprecedented systemic challenges and mounting compliance pressures. These policies are having a profound impact on key aspects of BD transactions, including deal structuring, drafting and review of transaction documents, valuation negotiations, supply chain arrangements, and even capital flows. In light of the multi-dimensional and deep-rooted impacts of these U.S. policies, which significantly constrain and increase the uncertainty surrounding China-U.S. cross-border BD transactions, this article aims to assist Chinese pharmaceutical companies in effectively identifying risks, seizing opportunities, and achieving compliant cooperation. To this end, this article first provides a systematic overview and summary of key recent U.S. pharmaceutical policy developments—including legislative updates on the BIOSECURE Act, new regulations on outbound transfers of sensitive personal data, specific clinical trial bans issued by the U.S. Food and Drug Administration (“FDA”), foreign investment restrictions, and tariff measures. On that basis, this article further examines the entire lifecycle of cross-border BD transactions, and, drawing from real-world business scenarios, provides practical compliance strategies and recommendations tailored to each policy domain, with the aim of helping pharmaceutical companies to overcome policy barriers and establish stable and compliant international partnerships. TONACEA 02 Impacts of Recent U.S. Pharmaceutical Policies on China-U.S. Cross-Border BD Transactions and Compliance Recommendations 01 The U.S. BIOSECURE Act 1.Overview of the Regulatory Framework of the U.S. BIOSECURE Act To date1, draft versions of the U.S. BIOSECURE Act have been approved by both the U.S. Senate and House of Representatives. The Senate-approved version is S.3558, titled the “Prohibiting Foreign Access to American Genetic Information Act of 2024” (“Senate Version”)2, and the House-approved version is H.R.8333, titled the “BIOSECURE Act” (“House Version”)3. Substantively, there are no major differences between the two versions.  Initially, it was anticipated that the BIOSECURE Act would undergo fast track legislation process via inclusion in the National Defense Authorization Act for Fiscal Year 2025 (“2025 NDAA”) by the end of 2024. However, this expedited legislative strategy was not exercised in practice. As a result, the BIOSECURE Act has not yet taken effect. Nevertheless, the possibility of the BIOSECURE Act becoming law remains significant. It may still proceed through standalone legislation. Given that both the Senate and the House have passed initial drafts, and there has been a bipartisan consensus to impose restrictions on Chinese pharmaceutical companies, it suggests a high likelihood of final enactment of the BIOSECURE Act.  Consequently, relevant enterprises should pay close attention to the regulatory framework proposed by the BIOSECURE Act closely monitor its legislative progress and assess the potential impacts of its enactment on existing business operations and continuity. 2.Key Takeaways of the BIOSECURE Act Both the Senate Version and the House Version of the BIOSECURE Act prohibit U.S. executive agencies from procuring or obtaining biotechnology equipment or services from a “biotechnology company of concern.” They also prohibit entering into or renewing contracts involving the use of such equipment or services. Additionally, they prohibit the use of federal funds (grants or loans) for such transactions and bar recipients of federal funds from engaging in these transactions.  Therefore, there are two main factors in determining whether a certain behavior or activity needs to be regulated by the BIOSECURE Act: first, whether the relevant entity is identified as a biotechnology company of concern; second, whether it involves or is classified as prohibited behavior defined in the BIOSECURE Act. Currently, the biotechnology companies of concern clearly listed by the BIOSECURE Act include WuXi AppTec, BGI, MGI, Complete Genomics (a subsidiary of MGI), WuXi Biologics, and their affiliated entities.  The BIOSECURE Act also authorizes the Office of Management and Budget (OMB), in conjunction with relevant departments, to dynamically maintain and update the list of the biotechnology companies of concern. (1)Criteria for Designating a Biotechnology Company of Concern As for the scope of the biotechnology company of concern4, in addition to the specifically listed entities such as WuXi AppTec and BGI, the BIOSECURE Act also allows the U.S. government to designate any entity meeting the following conditions as a biotechnology company of concern: (a)The entity that is subject to the jurisdiction, control, or acts on behalf of a foreign adversary (including China, Russia, Iran, and North Korea). Please note that the Senate and House Versions differ in their legal terminology regarding “jurisdiction”: the Senate version uses “jurisdiction,” whereas the House version uses “administrative governance structure”; the former may encompass broader forms of government influence such as state capital control or following government directives, even without formal organizational subordination. (b)The entity that is involved to any extent in the manufacture, distribution, provision, or procurement of biotechnology equipment or services. (c)The entity that is engaged in activities deemed to pose a national security threat to the United States. The aforementioned activities include: (i) joint research or having support or affiliation relationship with foreign adversary military, security, or intelligence agencies; (ii) provision of human multi-omics data obtained through biotechnology equipment or services to foreign governments; (iii) collection of such data without clear informed consent. (2)Prohibited Conduct The BIOSECURE Act proposes to outline the following three tiers of prohibitions5: First tier is the direct procurement ban: U.S. executive agencies shall not procure or obtain biotechnology equipment or services produced or provided by a biotechnology company of concern; Second tier is the indirect collaboration ban: U.S. executive agencies shall not enter into or renew contracts that involve or are reasonably expected to involve the use of biotechnology equipment or services produced or provided by a biotechnology company of concern; Third tier is the funding restrictions: U.S. executive agencies and federal fund recipients shall not use federal grants or loans to procure or obtain biotechnology equipment or services produced or provided by a biotechnology company of concern and shall not enter into or renew contracts that involve such transactions. The scope of biotechnology equipment or services in the aforementioned three-tier prohibition system has a very broad scope6, specifically including: (a)equipment, including genetic sequencers, mass spectrometers, polymerase chain reaction machines, or any other instrument, apparatus, machine, or device, including components and accessories thereof, that is designed for use in the research, development, production, or analysis of biological materials as well as any software, firmware, or other digital components that are specifically designed for use in, and necessary for the operation of, such equipment; (b)any service for the research, development, production, analysis, detection, or provision of information, including data storage and transmission related to biological materials, including—(i) advising, consulting, or support services with respect to the use or implementation of an instrument, apparatus, machine, or device described in subparagraph (a); and(ii) disease detection, genealogical information, and related services; and (c)any other service, instrument, apparatus, machine, component, accessory, device, software, or firmware that the relevant government agencies determine appropriate after consultation for the purpose of protection national security. 3.Compliance Recommendations regarding BIOSECURE Act  (1)Supplier Risk Assessment Although the BIOSECURE Act does not directly influence the China-U.S. cross-border BD transactions, its broad definition of biotechnology equipment/services—potentially including core CRO services—could significantly disrupt R&D process and pipeline valuation of Chinese pharmaceutical companies if relevant suppliers are deemed as a biotechnology company of concern under the BIOSECURE Act. Therefore, we tend to recommend Chinese pharmaceutical companies to take the following steps to conduct supplier risk assessment: First, identify if current suppliers of biotechnology equipment or services， and their affiliated entities, fall within the designated list of biotechnology companies of concern under the BIOSECURE Act, and state-owned Chinese firms should also be carefully reviewed. Second, assess the extent of the company’s connection with the U.S. federal government, including whether the company directly or indirectly provides services to the U.S. federal government, or directly or indirectly receives subsidies or funding from the federal government. Third, if risk exposure of suppliers of biotechnology equipment or services being designated as biotechnology companies of concern exists, proactively seek alternative suppliers and evaluate the timeline for transition. Furthermore, we tend to suggest that Chinese pharmaceutical companies continuously monitor the latest enactment of BIOSECURE Act and its related implementing regulations and respond promptly. (2)Review of Key Clause of Suppliers Contract The BIOSECURE Act—though not yet effective—signals growing geopolitical risk impacting the stability of supply chains in the pharmaceutical sector. Therefore, we tend to suggest that Chinese pharmaceutical companies focus on reviewing the following key clauses in the supplier’s contract: First, termination rights: Check whether contracts allow unconditional termination in the event of a government ban and assess the enforceability of such clause; Second, ensuring smooth technology transfer: require suppliers to transfer complete research results, research data and deliverables at termination free of charge, and make sure that the company retains complete IP ownership of such data and materials. 02 Outbound Transfers of U.S. Sensitive Personal Data 1.Overview of U.S. Regulations on Outbound Transfers of Sensitive Personal Data On February 28, 2024, the Biden Administration issued Executive Order 14117, titled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (“Executive Order 14117”)7, which determines that countries of concern such as China and Russia and covered persons pose a national security threat through access to U.S. citizens’ sensitive personal data. The Order directed the U.S. Department of Justice to develop implementing rules to restrict access of countries of concern and covered person to bulk sensitive personal data of U.S. citizens.  On April 8, 2025, the U.S. Department of Justice's corresponding implementing rule of Executive Order 14117, titled “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons” (the “Final Rule”)8, came into effect. 2.Key Takeaways of U.S. Regulation on Outbound Transfers of Sensitive Personal Data (1)Definition of Sensitive Personal Data and Threshold for Bulk Data “Sensitive Personal Data” covers the following six categories of information and their combinations: Covered Personal Identifiers, Precise Geolocation Data, Biometric Identifiers, Human 'Omic Data, Personal Health Data, etc9. The standard for determining “Bulk”10 is if the quantity of any sensitive personal data meets or exceeds specific thresholds within the past 12 months, whether through a single covered data transaction or multiple data transactions involving the same U.S. individual and the same foreign entity or covered person. A summary of the definition of the six types of sensitive personal data and their corresponding thresholds for reaching the “bulk” criterion is as follows: Furthermore, the following types of data are not classified as sensitive personal data12: (a)Public or non-public data unrelated to individuals, including trade secrets and proprietary information; (b)Data lawfully made available at the time of transaction through federal, state, or local government records (e.g., court records) or widely distributed media; (c)Personal communications; and (d)Information or informational materials and ordinarily associated metadata or metadata reasonably necessary to enable the transmission or dissemination of such information or informational materials. (2)Countries of Concern and Covered Persons “Countries of Concern” include China (including Hong Kong and Macao), Cuba, Iran, North Korea, Russia, and Venezuela13. “Covered Persons” include14： (a)Entities established in or with a principal place of business in a country of concern, or foreign entities directly or indirectly, solely or jointly, owned 50% or more by countries of concern or entities listed in (b); (b)Foreign entities directly or indirectly, solely or jointly, owned 50% or more by entities listed in (a), (c), (d), or (e); (c)Employees or contractors of entities listed in (a), (b), or (e); (d)Foreign individuals primarily residing within the jurisdiction of a country of concern; and (e)Any person deemed by the U.S. Department of Justice to be controlled by or acting on behalf of a country of concern or a covered person. (3)Regulatory Measures Unless permitted or exempted, covered data transactions between U.S. persons and countries of concern or covered persons are prohibited or restricted. A “covered data transaction” refers to any transaction that allows a country of concern or a covered person to access bulk U.S. sensitive personal data, including:(a) Data brokerage agreements;(b) Vendor contracts;(c) Employment agreements; or(d) Investment agreements15. 3.Compliance Recommendations for Outbound Transfers of U.S. Sensitive Personal Data (1) Identify the Type of Data Involved in the Project We tend to suggest that pharmaceutical companies, prior to initiating multi-center clinical trials or cross-border technology transactions, identify the types of data involved in the project and determine whether such data falls under regulated categories, in order to better comply with regulatory requirements. For example, if a cross-border technology transfer involves preclinical-stage chemical drug technology, it typically only includes preclinical research data such as pharmacology, toxicology, and animal study data—making it less likely to be regulated. Conversely, if the project is in the clinical stage or involves multinational clinical trials (including in the U.S.), we tend to believe that it will likely involve sensitive personal data because clinical trials involve testing on human subjects (patients or healthy volunteers)16, and therefore be subject to U.S. regulations on the outbound transfer of sensitive personal data. (2)Clarify Whether Cross-Border Data Transfers are Involved before Initiating the Project Once the data types involved in the project are identified, we tend to suggest that pharmaceutical companies should further determine whether the project involves transferring data from the U.S. to China. If so, we tend to suggest that pharmaceutical companies should learn about the U.S. cross-border data transfer rules regarding the specific transferred data type, assess whether any exemptions apply, proceed with the necessary approvals, filings, security assessments and other administrative proceedings, implement the corresponding data security system, and take necessary data security measures. (3)Specify Compliance Requirements and Obligations of the Parties regarding Cross-Border Data Transfer in Transaction Documents We tend to suggest that pharmaceutical companies should establish internal compliance management protocols and systems regarding data cross-border transfer and improve internal data security systems. For cross-border transactions, we tend to suggest that pharmaceutical companies should explicitly specify the specific compliance obligations of data cross-border transfer and should further specify the corresponding responsibilities of the parties in the transaction documents, in order to ensure regulatory compliance of the transaction. Failure to do so may result in legal risk of different extent, including the destruction of data or other sanctions/regulatory penalties. For example, in a licensing deal where a Chinese company acquires U.S. pharmaceutical technology involving large volumes of sensitive personal data. On one hand, we tend to suggest that the Licensee require the Licensor to ensure compliance with regulations on U.S. sensitive personal data transferring to China—covering administrative procedures and internal data security system establishment—in order to prevent obstacles related to data cross-border transfer in the transaction. On the other hand, we tend to suggest that the Licensor should also obtain informed consent from data subjects and provide representations and warranties regarding ethical approvals. (4)Continuously Monitor Regulatory Developments on Cross-Border Data Transfers between China and the U.S. Recently, there were increasingly stringent and frequently updated U.S. regulations on cross-border transfers of U.S. citizens’ personal data to China. To minimize the risk of project delays or failures caused by cross-border data transfer issues, we tend to suggest that pharmaceutical companies should closely monitor regulatory developments and enforcement trends in the area of China–U.S. cross-border data transfers, and should accordingly improve their internal and project-related regulatory procedures and/or approvals and filings, and adjust their business models and strategies, in order to ensure smooth project implementation and long-term compliance. 03 FDA Suspension of Clinical Trials Involving Export of U.S. Citizens' Cells to Chinese Laboratories for Genetic Engineering Research 1.Overview and Key Takeaways of the FDA Clinical Trial Ban On June 18, 2025, FDA announced the immediate suspension of all newly initiated clinical trials involving the export of U.S. citizens’ cells to China or other adversarial countries for genetic engineering research, with subsequent reinfusion into U.S. patients (“FDA Clinical Trial Ban”)17. This ban was issued in response to the FDA's discovery that certain relevant clinical trials failed to inform participants that their biological materials would be subject to cross-border transfer and human manipulation, which could result in the sensitive genetic data of U.S. citizens being improperly used by foreign governments—particularly those of adversarial nations. The FDA attributed these compliance failures to a loophole in the Final Rule: while the transfer of sensitive data to countries of concern is generally restricted, U.S. companies were permitted to export biological samples (including DNA) from clinical trial participants abroad for processing, as part of FDA-regulated clinical trials. However, this exemption was found to be abused in practice, including in clinical trials involving companies partially owned or controlled by the Chinese Communist Party. As a result, the FDA is actively reviewing all clinical trials relying on this exemption and now requires relevant companies to demonstrate full transparency, ethical consent, and domestic processing of sensitive biological materials. New clinical trial applications that fail to meet these standards will not be accepted. Additionally, the FDA is collaborating with the U.S. National Institutes of Health (NIH) to establish a joint review mechanism to ensure that no federal funded research would include conduct prohibited under the FDA Clinical Trial Ban. More implementation details are forthcoming. 2.Compliance Recommendations in Response to the FDA Clinical Trial Ban (1)Review of U.S.-Involved Clinical Trial Projects We tend to suggest that pharmaceutical companies conduct a comprehensive review of all clinical trial projects involving the U.S. entity—such as international multi-center trials or collaborations with U.S. entities in the CGT area. The review should focus on identifying whether any projects involve transporting live cells from U.S. citizens to China for genetic engineering, followed by reinfusion into U.S. patients. If such cases exist, the trials may be subject to suspension by the FDA. For other clinical trials involving the transfer of U.S. citizens’ biological samples (including DNA) to China for processing, we tend to suggest that companies could closely examine whether informed consent documents are fully signed, and ensure that U.S. participants have explicitly authorized the cross-border transfer and genetic editing of their biological samples (e.g., CAR-T cell modification abroad); additional clauses addressing cross-border risks may be included in the informed consent documentation. (2)Response Measures to the FDA Clinical Trial Ban First, localize the processing of biological samples. We tend to suggest that pharmaceutical companies should avoid transporting live cells of U.S. citizens to China and instead relocate genetic editing, sequencing, and other core procedures to FDA-approved institutions within the United States, thereby preventing disruption to clinical trial timelines and drug R&D regulatory submissions. Second, include clear compliance requirements and parties’ responsibilities in the contracts. For clinical trial projects involving U.S. citizens’ biological samples, we tend to suggest that pharmaceutical companies should focus on the following key contractual provisions to ensure compliance requirements: (a)require the relevant party to commit that sensitive biological materials from U.S. citizens will not be processed in China, specify alternative solutions and execution requirements, and provide that breach of this clause should trigger the other party’s right to terminate the contract and seek punitive damages; (b)require the relevant party to represent and warrant that the clinical trial has obtained ethical approval, and that informed consent from U.S. participants has been properly obtained; to provide informed consent templates approved by ethics committees; and to retain signed consent forms from U.S. participants for audit purposes. 04 U.S. Foreign Investment Restrictions 1.Overview of U.S. Foreign Investment Regulation Since President Trump took office in 2018, the United States has continuously strengthened restrictions on Chinese capital in the investment sector. A summary of the relevant laws and regulations currently in effect is as follows: In addition to the above, on February 21, 2025, President Trump signed the “America First Investment Policy” memorandum (“Memorandum”)22, aimed at further restricting investments from adversarial countries such as China in U.S. enterprises and critical technologies (including pharmaceuticals), and at enhancing relevant investment review. While the Memorandum itself does not directly establish new laws or regulations, it instructs relevant administrative agencies to initiate corresponding rulemaking procedures to implement the principles stated in the Memorandum. 2.Key Takeaways of U.S. Foreign Investment Regulation (1)Covered Investments CFIUS has authority to review “covered investments” meeting the following criteria23 investments by foreign investors in U.S. businesses engaged in TID (Technologies, Infrastructure, or Sensitive Personal Data) activities; and such investments result in the foreign investor obtaining any of the following rights: access to “material nonpublic technical information” held by the U.S. business, the right to nominate a board member or board observer, the ability to participate in “substantive decision-making” of the U.S. business beyond mere voting rights. Among these, the following transactions require mandatory declaration, while others are subject to voluntary declaration24. (a)A foreign investor obtains a “substantial interest” (25% or more of voting rights) in a U.S. enterprise conducting TID business, and a government entity holds a “substantial interest” (49% or more) in the foreign investor25. (b)Involving U.S. enterprises engaged in critical technologies (T) business, and the export or transfer of such technologies to certain foreign investor requires U.S. regulatory authorization (mainly under export controls), and if a foreign entity holds 25% or more of the voting rights in the foreign investor, a mandatory declaration is also required26. (2)Trends in U.S. Foreign Investment Regulation Regarding Chinese investment in the U.S., the U.S. government is expected to utilize a range of legal tools—including CFIUS—to intensify scrutiny of investments from “foreign adversaries” such as China, particularly in strategic sectors like healthcare27. Notably, CFIUS’ authority is likely to expand beyond traditional M&A to also cover greenfield investments, in order to prevent foreign adversaries from accessing U.S. talent and operational resources in sensitive technology sectors, and the scope of “emerging and foundational technologies” subject to CFIUS’ review will also be expanded. On outbound U.S. investment in China, the U.S. government also plans to adopt stricter restrictions to Chinese entities28, with a focus on industries associated with China’s “military-civil fusion” strategy, such as biotechnology. These restrictions may apply to a range of investment forms, including private equity, venture capital, greenfield investments, corporate expansions, and public market securities. Affected parties may include institutional investors such as pension funds and university endowments. (3)Impact and Compliance Recommendations regarding U.S. Foreign Investment Policy At present, U.S. is steadily tightening restrictions on China in key investment sectors such as pharmaceuticals, and the uncertainty faced by Chinese capital seeking to invest in U.S. biotech firms has increased sharply, and heightened scrutiny appears to be a definitive trend. Meanwhile, U.S. capital entering relevant sectors in China is also encountering increasing barriers. This two-way tightening trend undoubtedly poses long-term challenges to China–U.S. technology cooperation, business transactions, and capital flows. Given these dynamics, we tend to suggest that Chinese pharmaceutical companies adopt the following proactive strategies—particularly under NewCo deal structures involving equity transactions: First, systematically assess and manage U.S. foreign investment regulatory risks. For any investment plan involving U.S. assets, technology, or operations—especially when cooperating with a U.S. partner in NewCo projects—professional legal advisors should be engaged early to analyze whether the transaction structure may trigger CFIUS review, and a detailed response plan should be prepared in advance, including declaration materials and evaluation of the need for mandatory declarations. Second, accelerate the diversification strategy of financing channels. Chinese pharmaceutical companies could actively explore funding sources outside the U.S., actively seek international capital market opportunities in Europe, Asia, and other regions, and further unlock the potential of the domestic capital market. This will reduce dependence on financing from a single (especially U.S.) market and mitigate the impact of sudden U.S. policy shifts. Finally, on the basis of maintaining survival and development, proactively explore international cooperation and investment opportunities outside of U.S.-dominated channels. Strategically, Chinese pharmaceutical companies may consider shifting R&D and manufacturing center to jurisdictions with more favorable or stable policy environments, to build a more resilient global footprint. 05 U.S. Tariff Restrictions 1.Overview of U.S. Tariff Policy On April 2, 2025, based on Executive Order No. 1425729, the U.S. government imposed a 34% “Reciprocal Tariff” on goods exported from China to the U.S. Annex II of Executive Order No. 14257 grants exemptions to most pharmaceuticals and biological products, including chemical drug preparations, vaccines, and antibodies. However, it retains full tariffs on medical devices and consumables such as syringes, needles, and medical gloves, which are not included in the tariff exemption scope. On April 8, 2025, pursuant to Executive Order No. 1425930, the U.S. government imposed an additional 50% tariff on goods exported from China to the U.S., raising the total tariff rate to 104%. On April 9, 2025, based on Executive Order No. 1426631, the U.S. government announced an immediate increase of the tariff rate to 125% (combining the additional 20% fentanyl-related tariff imposed in February–March 2025, the total tariff rate reaches 145%). On May 12, 2025, China and the United States jointly issued the “Joint Statement on U.S.-China Economic and Trade Meeting in Geneva”32, in which the U.S. made the following interim concessions: (1) modify the application of the additional ad valorem rate of duty on articles of China set forth in Executive Order 14257 of April 2, 2025, by suspending 24 percentage points of that rate for an initial period of 90 days, while retaining the remaining ad valorem rate of 10 percent on those articles pursuant to the terms of said Order; and (2) removing the modified additional ad valorem rates of duty on those articles imposed by Executive Order 14259 of April 8, 2025 and Executive Order 14266 of April 9, 2025. 2.Impact of U.S. Tariff Policy on Cross-Border BD Transactions U.S. tariff policies are designed to target the circulation of tangible goods. In contrast, most cross-border BD transactions in the pharmaceutical industry essentially involve the licensing transaction of intellectual property rather than trade in physical goods. The core subject matter in BD transactions includes patents, proprietary technologies, and other intangible assets, with payments for royalties and transfers of technical documents currently not subject to tariff mechanisms. Therefore, the current U.S. tariff policy has a limited direct impact on pharmaceutical cross-border BD transactions. However, it is not ruled out that the U.S. government may introduce restrictions related to technology-based BD transactions in the future. 3.Compliance Recommendations for U.S. Tariff Restrictions Although U.S. tariff policy currently has limited direct impact on pharmaceutical cross-border BD transactions, this does not mean that relevant enterprises can overlook the indirect consequences and strategic challenges resulting from changes in the tariff policy. We tend to believe that tariff policy fluctuations may indirectly affect the financial terms of License-out transactions, particularly the upfront payments and milestone payments. The transmission mechanism lies in the fact that tariff increases raise the cost of future innovative drug trade, leading U.S. licensees to take a more cautious approach in evaluating transaction value during negotiations. For example, when a Chinese pharmaceutical company licenses an innovative drug technology to a U.S. partner, the latter may, anticipating higher production costs and sales prices due to tariffs and the resulting suppressed market demand, seek to reduce upfront payments or impose higher sales performance thresholds and lower milestone payments to hedge against cost increases and market risks. This type of pricing pressure, derived from tariff-related cost transmission, may indirectly impact the short-term cash inflows and long-term revenue expectations of Chinese pharmaceutical enterprises. We tend to believe that the more profound impact lies in global supply chain layout and market strategy. To reduce dependence on the single U.S. market and mitigate tariff risks, we tend to suggest that Chinese pharmaceutical companies should actively consider adjusting their industrial footprint to accelerate supply chain diversification: (1)For companies already operating in the U.S., it may be strategic to use their U.S.-based entities for strategic product stockpiling; at the same time, companies should actively invest in low-tariff countries or regions to establish manufacturing facilities that meet strict local regulatory requirements and obtain local GMP certifications. Although this process involves high preliminary investments (e.g., plant construction, certifications, and coping with rising overseas operational costs) and brings short-term cost increases and capacity adjustment challenges. From a long-term perspective, achieving multi-regional production can effectively disperse geopolitical risks, significantly enhance supply chain resilience, and improve market responsiveness. Its strategic necessity is self-evident.  (2)On the basis of effectively balancing survival and development, proactively expand into markets other than the U.S., enhancing their presence in Europe, Japan, and other key regions, while also actively exploring emerging markets. A diversified market structure will help offset the negative impacts of U.S. tariff policies. We believe that a more resilient global industrial footprint will also enhance the value of Chinese pharmaceutical companies’ pipelines in cross-border BD transactions. Finally, we tend to suggest that pharmaceutical enterprises should establish a dynamic tariff policy monitoring and response mechanism. Enterprises should closely monitor adjustments in U.S. and other relevant countries’ tariff policies, promptly assess their potential impact on supply chains and the BD transaction environment, in order to quickly adapt supply chain strategies and commercial negotiation approaches. TONACEA 03 Conclusion and Prospect In the face of the recent surge and ongoing evolution of regulatory policies in the U.S. pharmaceutical sector, Chinese pharmaceutical companies are experiencing unprecedented compliance risks and challenges in China–U.S. cross-border business development (BD) transactions.  This article has systematically outlined the core elements of key policies—including the legislative developments of the BIOSECURE Act, the new regulations on outbound transfers of sensitive personal data, the FDA’s ban on specific clinical trials, foreign investment review, and tariff measures—as well as corresponding compliance strategies for Chinese pharmaceutical enterprises. However, the scope of compliance risks extends far beyond these areas. Chinese pharmaceutical companies should also pay close attention to compliance requirements in other critical risk domains, such as cross-border tax compliance, regulatory oversight of the import and export of biologics, export controls, and economic sanctions, etc. From a long-term development perspective, compliance serves as a critical cornerstone for the successful completion of cross-border BD transactions and the subsequent implementation. Only by fostering a comprehensive and forward-looking compliance mindset and establishing a dynamic risk management system that spans the entire value chain and multiple regulatory domains can Chinese pharmaceutical companies effectively identify risks, seize opportunities, and navigate steadily in the complex environment shaped by China–U.S. policy tensions. We tend to suggest that: where commercially feasible, Chinese pharmaceutical companies could appoint dedicated compliance personnel or specialized positions to continuously track the latest regulatory developments and enforcement trends in both China, the U.S., and other target markets; legal, tax, and government affairs experts should be brought into the transaction at an early stage to conduct comprehensive compliance due diligence and risk assessment. Dring the cross-border transaction, compliance requirements should be deeply embedded in the BD deal structure, contractual negotiations, and day-to-day operations to ensure the sustainability of business expansion. We will also continue to closely monitor the introduction of new China–U.S. regulatory policies and shifts in enforcement approaches, with the goal of supporting the internationalization and global expansion of Chinese pharmaceutical companies. Author: Tina Liu, Daniel Huang, Yan Zhang Author Team Profile Tina Liu （上下滑动查看更多） Tina Liu is a partner lawyer at AllBright Law Offices in Shanghai Office and is currently the deputy chair of the Business Development Committee of the China Biomedical Industry Chain Innovation and Transformation Alliance (CBIITA Alliance). Ms. Liu ranked among the Top 30 Outstanding Lawyers in the Chinese legal field for the year 2023 by the well-known legal rating agency LEGALBAND, and key recommended lawyer in the field of life sciences and healthcare in the 2024 edition of “The Legal 500”. Ms. Liu’s practice is focused in the areas of Life Science and Healthcare. Ms. Liu has represented well-known foreign pharmaceutical and medical device companies (including but not limited to AstraZeneca, Abbott, Siemens Healthineers, MSD, Boehringer Ingelheim, Roche, BeiGene, Aspen, Menarini, CSPC, I-Mab, China Medical System, Betta Pharmaceuticals, Wantai BioPharm, IMPACT Therapeutics, Avistone, etc.), medical institutions (including but not limited to the first foreign-funded grade A tertiary hospital and top public grade A tertiary hospital in China), medical (health) group, Internet medical and health enterprises, insurance companies and professional fund companies specializing in medical and pharmaceutical equipment projects for domestic and foreign investment and acquisition, cross-border pharmaceutical technology transactions and cooperation, regulatory compliance, dispute resolution, etc. , which assisted domestic and foreign well-known pharmaceutical companies to carry out cross-border License in/out technology transactions and cooperative development projects. Ms. Liu graduated from East China University of Political Science and Law. Ms. Liu has published over a hundred articles in the field of life sciences and healthcare law. Some representative research works include: A Series of Articles on Pharmaceutical Technology Transactions Practices for Pharmaceutical Companies (Chinese and English versions, 2023, published jointly with Healthcare Executive); Practical Manual for the Establishment, Merger, and Compliance Management of Medical Institutions (2023, jointly published with Wolters Kluwer Legal Database); Analysis Report on Medical Industry Administrative Penalty Risks and Prevention (2020, jointly published with Wolters Kluwer Legal Database); Legal and Regulatory Report on Medical AI- the chapter of Industry Development and Status, Medical AI Product Liability (2019, jointly published with Tencent Health, the first AI legal research report in China). TEL：15216738527 E-mail：tinaliu@allbrightlaw.com Daniel Huang （上下滑动查看更多） Mr. Huang is a Senior Associate at AllBright Law Offices in Shanghai Office and a Certified Anti-Money Laundering Specialist (CAMS).  Mr. Huang mainly practices legal services in the fields of Health & Life Science, Banking Compliance, Financial Crime Legal and Compliance area. Mr. Huang has represented well known foreign pharmaceutical and medical device companies (including but not limited to Roche, Menarini, CSPC Pharmaceutical Group, Jingxin, China Medical System, Betta Pharmaceuticals, Wantai BioPharm, IMPACT Therapeutics, Goodwill, Innoforce, Avistone, Symraybio, SeekIn, Genhouse, Neologics, DiQi Pharmaceuticals, Biocasting, Neoantigen, Minovapharma, Leading-optics, SynthAsiaChina, Sunshine Medical Technology. Heartrhythm, United-imaging, etc.) for legal service covered Daily business, R&D and clinical, operational and data compliance, overseas investment, equity financing, and cross-border BD transactions. Mr. Huang graduated from East China University of Political Science and Law with a bachelor’s degree in law and a bachelor’s degree in economics (Finance). TEL：18817836896 E-mail：hgh@allbrightlaw.com Yan Zhang Yan Zhang is a Paralegal at AllBright Law Offices in Shanghai Office. Ms. Zhang received her LLB & LLM degrees from East China University of Political Science and Law, and her LLM degree from New York University School of Law. Ms. Zhang has interned and worked for well-known international law firms and PRC law firms in PE/VC and M&A teams for a long time. Ms. Zhang focuses on healthcare and pharmaceuticals, PE/VC, M&A, and corporate compliance. Reference: (Swipe up and down to see more) 1.July 22, 2025. 2.https://www.congress.gov/bill/118th-congress/senate-bill/3558/text. 3.https://www.congress.gov/bill/118th-congress/house-bill/8333/all-actions. 4.Article 2(f) of the Senate Version and the House Version. 5.Article 2 of the Senate Version and the House Version. 6.Article2(k)(2) of the Senate Version and the House Version. 7.https://www.federalregister.gov/documents/2024/03/01/2024-04573/preventing-access-to-americans-bulk-sensitive-personal-data-and-united-states-government-related. 8.https://www.federalregister.gov/documents/2025/01/08/2024-31486/preventing-access-to-us-sensitive-personal-data-and-government-related-data-by-countries-of-concern.  9.§202.249 of Final Rule. 10.§202.205 of Final Rule. 11.“Listed identifier” refers to full or truncated government identification or account number, full financial account numbers or personal identification numbers associated with a financial institution or financial-services company, device-based or hardware-based identifiers, demographic or contact data, advertising identifiers, account-authentication data, network-based identifiers, and call-detail data. 12.§202.249 of Final Rule. 13.§202.601 of Final Rule. 14.§202.211 of Final Rule. 15.Subpart C, D of Final Rule. 16.Article 11 of Good Clinical Practice in China. 17.https://www.fda.gov/news-events/press-announcements/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic. 18.https://home.treasury.gov/sites/default/files/2018-08/The-Foreign-Investment-Risk-Review-Modernization-Act-of-2018-FIRRMA_0.pdf.  19.https://home.treasury.gov/system/files/206/Part-800-Final-Rule-Jan-17-2020.pdf. 20.https://home.treasury.gov/system/files/206/Part-802-Final-Rule-Jan-17-2020.pdf. 21.https://www.govinfo.gov/content/pkg/FR-2022-09-20/pdf/2022-20450.pdf. 22.https://www.whitehouse.gov/presidential-actions/2025/02/america-first-investment-policy/. 23.Article 401(c) of 31 C.F.R Part 800. 24.Article 2(f) of the Memorandum. 25.Article 2(j) of the Memorandum. 26.Article 401(c) of 31 C.F.R Part 800. 27.Article 2(f) of the Memorandum. 28.Article 2(j) of the Memorandum. 29.https://public-inspection.federalregister.gov/2025-06063.pdf. 30.https://www.whitehouse.gov/presidential-actions/2025/04/amendment-to-recipricol-tariffs-and-updated-duties-as-applied-to-low-value-imports-from-the-peoples-republic-of-china/. 31.https://www.whitehouse.gov/presidential-actions/2025/04/modifying-reciprocal-tariff-rates-to-reflect-trading-partner-retaliation-and-alignment/. 32.https://www.whitehouse.gov/briefings-statements/2025/05/joint-statement-on-u-s-china-economic-and-trade-meeting-in-geneva/.