Wuxi Biologics (Cayman), Inc.

中药“航母”们一股脑地驶向生物药的新大陆。 撰文| Kathy 很少有人会将一款在FDA获批的FIC药物与一家中国的传统中药龙头联系起来，但这种小概率事情实实在在地发生了。 8月7日，Jazz制药宣布FDA加速批准其口服活性小分子DRD2拮抗剂和ClpP激动剂Dordaviprone（多达维普酮）上市，用于治疗年龄≥1岁前线治疗进展的携带H3 K27M突变的弥漫性中线胶质瘤（DMG）患者。Jazz制药称，此为FDA批准的首个且唯一的治疗该适应证的药物。 伴随着获批被推到聚光灯下的，除了这家来自爱尔兰的生物医药公司外，还有一家中国本土的中药龙头——华润三九。拉长时间线就会发现，这款药物在国内的开发、生产和商业化权益，早在2020年12月，就被华润三九拿下了。 熟悉华润三九的人，大多会对它“国民中药品牌”的身份印象深刻，999感冒灵、三九胃泰、999皮炎平……可以不夸张的说，“三九”这个品牌算得上在中国医药消费市场上，中药消费品赛道的中坚代表之一。 这家被外界视作央企中药航母的赛道龙头，在过去一段里，也悄悄发生了一些变化：先是今年6月，其官宣与南京艾尔普合作，一起推进干细胞治疗心衰的细胞药物HiCM-188；一个多月后，今年8月1日，华润三九又出手了，这次更高调，宣布与博瑞医药达成协议，引进GLP-1/GIP双靶点的口服创新药，直接杀入当下最热的代谢赛道。 华润三九做化药、生物药，听起来像天方夜谭。这些与其典型的中药标签几乎不相干的操作背后，是一个中药公司正在向生物药和创新药的试探。 而华润三九不是唯一这样做的中药企业，甚至不是做的最快、最早的。云南白药、康缘药业、片仔癀、白云山、步长制药，中药龙头们几乎都在一股脑地“跨界创新”…… 中药龙头的创新药野望 为数不多的几起创新药BD交易，华润三九的布局几乎都聚焦在高技术壁垒的前沿技术领域。 干细胞疗法是再生医学赛道的最前沿技术之一，至今全球商业化产品仍屈指可数；GLP-1项目则是近年来资本和产业追逐的“顶流”，尤其是双靶点、口服剂型，竞争尤为激烈；而脑瘤FIC新药，则是瞄准了临床未被满足的巨大需求。 虽然所属赛道不同，但这些项目有着相似的特征：研发门槛高，且在临床价值、政策支持、未来市场空间等方面具备“突破性”。相较于传统中药以“证候”与“经验”为核心逻辑的路径，钻到创新药的研发之中也让中药企业的跨界更具有“反转”意味。 以GLP-1项目为例，华润三九合作的是博瑞医药自主开发的口服小分子双受体激动剂BGM0504。根据协议，华润三九获得了一项“可分许可的排他性合作开发实施许可”和一项“可分许可的独占性商业化实施许可”，而博瑞医药保留了全部专利权，全资子公司博瑞制药作为唯一上市许可持有人（MAH），承担药品全生命周期责任。 这是一款在二级市场上掀起过不小水花的减肥药，2023年10月时，博瑞医药董事长袁建栋在投资者电话会议中表示“不到两个月，自己的体重从91kg下降到了76kg。”虽然袁建栋被江苏证监局出具警示函，但并不影响博瑞医药搭上GLP-1概念股顺风车后股价飙涨。直到今年，博瑞医药公布BGM0504的II期临床试验数据：5mg、10mg、15mg组给药24周后，体重较基线平均降幅分别为10.77%、16.21%、19.78%。市场再次为此“买单”，博瑞医药股价直接翻倍。 但资本市场的热捧与真实的销售还是有区别的，BGM0504尚处于临床，待到上市时，市场格局只会比如今更激烈。再加上博瑞医药的现金储备并不宽裕，Q1期末现金及现金等价物余额约8亿元。今年7月博瑞医药还发布了定增预案，打算募资5亿元补充流动资金和偿还银行贷款。 对博瑞医药来说，华润三九的出现并承担博瑞医药一部分研发费用，可以说是一场及时雨。对华润三九来说，未来能灵活组建销售联盟，尤其利于基层市场覆盖。并且费用方面也算是对赌，2.82亿里程碑付款绑定III期临床进度，降低了华润三九在前期研发中的风险。 华润三九选择BGM0504，不仅仅是赌GLP-1未来的消费市场，更是在利用自己在OTC与处方药渠道中长期积累的资源，寻找在消费属性与处方药渠道之间可以融合的产品。 再看HiCM-188，则是用于治疗心衰的iPSC来源心肌细胞药物，是国内首个获得临床默示许可的iPSC干细胞疗法，据GlobalData预测，全球主要国家的心衰药物市场规模将从2018年的37亿美元增长至2028年的221亿美元（约合人民币1590亿元），CAGR高达19.5%。 然而，目前针对心衰的标准治疗方法，只能够在一定程度上控制病情发展，对于逆转心力衰竭进程，尤其针对严重心衰患者，效果十分有限。 再加上心脏移植虽然被视为治疗终末期心脏病的最后手段，但由于供体器官的极度短缺，严重限制了其广泛应用。心肌细胞替代疗法作为一种极具潜力的方案应运而生。华润三九选择双方共同开发这款新一代细胞创新药，透露出既希望“搭上前沿技术班车”，同时又不过于激进的态度。行业预测，如果HiCM-188成功上市，不仅有望为华润三九进一步打开千亿级的心衰药物赛道，更将填补国内空白，创造心衰治疗的新方案，惠及全球患者。 FIC脑瘤药物Dordaviprone的选择则最具象征意义。这款药物是Jazz制药开发的儿童弥漫性中线胶质瘤靶向药，今年8月7日年获得FDA批准，针对的是H3 K27M突变患者，是全球第一个也是唯一一个靶向该突变的药物。华润三九不仅获得其在中国的权益，更是以临床试验申办方身份推动药物本地化开发。 如果说华润三九与博瑞医药、艾尔普再生医学的合作，依托的更多的是华润三九成熟的营销网络和处方药推广经验，那对Dordaviprone的临床研究，是对一家传统以中成药为主业的企业的研发能力的挑战与考验。 从公开信息来看，CDE在2023年批准其复发/进展性H3 K27M突变型弥漫性中线脑胶质瘤临床试验申请。同年11月华润三九在首都医科大学附属北京天坛医院和复旦大学附属华山医院启动1期临床研究（CTR20233492），计划入组58例患者。 三条不同的产品管线、赛道与技术背后，是华润三九在技术逻辑、产品逻辑与市场逻辑上的试水。既不完全以自研为核心驱动，也不单纯依赖资本杠杆进行爆发式收并购，而是渐进地在自身优势能力基础上的外延。  推荐阅读  * 中药业绩“雪崩”，2025靠什么翻盘？ * 中药大逃杀：当龙头也“崩”不住了 中药赚来的钱，做生物药的事 华润三九的跨界有其深层背景。这家年营收超过200亿元的中药巨头，并非遭遇切实的危机才被迫转型。事实上，它的CHC业务依然保持稳定增长，“999”品牌依旧是中国药品零售市场最具辨识度的产品之一。处方药业务虽受中药注射剂管控、新国标实施等因素影响出现结构性下滑，但整体营收盘面仍属稳健。在2024中国医药上市公司竞争力20强中，更是位居榜首。 或许，驱动转型的不在增长，而在结构。 以具体业务板块来看，CHC业务虽然增长良好，但增量主要来自品牌延伸与消费品扩展，缺乏技术性护城河；RX板块则毛利率下滑严重，核心产品中有多款面临医保谈判压价与品种替代。更重要的是，随着国家医保改革深入，传统中药的定价逻辑、市场逻辑正在被彻底改写。“中药吃老本”的时代，正在接近尾声。 同时，从资本市场角度来看，中药企业的估值天花板已经相对固定。华润三九的市盈率常年低于30倍，远低于信达生物、康方生物等创新药企动辄百倍起跳的估值逻辑。虽然华润三九不以估值导向为唯一目的，但在整个医药行业剧烈变化、投资人关注点持续转移的大背景下，寻找新的增长逻辑，成为一种战略上的必要。 于是，“卖中药赚的钱，拿来做创新药的研发”的新逻辑逐渐成型：保留盈利基础，以主业稳定提供“现金牛”，将资金、资源、组织适度注入创新药领域，用小规模的资金切口布局高潜力项目。 这种逻辑也不是个例。除华润三九外，云南白药、天士力、步长制药、白云山、片仔癀、悦康药业等一众中药企业，近年也陆续踏足化药、生物药甚至合成生物学领域。它们的路径不尽相同，有的自建研发中心，有的设立投资平台，有的进行海外并购，也有的深度绑定技术公司。但共通点在于：传统的中药赛道头部企业正集体向“高投入、高风险、高回报”的创新药靠拢。 究其原因不难发现，这些手上有充足的现金流的老牌中药企业，近年来也面临着越来越有限的业绩增长，日渐承压的业绩正把它们推向创新药赛道，以期找到下一个业绩增长密码。 像手握国家级保密配方的百年老字号云南白药，把眼光瞄向了核药。 2022年时，云南白药花费2000万元从北京大学第一医院、北京市肿瘤防治研究所引进了前列腺特异性膜抗原（PSMA）靶向核药相关专利，开启了核药的研发。 到2023年7月，云南白药成立云核医药全资子公司，进一步推动创新核药的研发与商业化。 今年4月，云南白药的核药研发再次迎来关键时刻，其核药管线INR102的临床试验申请获得NMPA批准，同意开展前列腺癌的临床试验。 据云南白药公告，这是其首个创新治疗核药产品，拟用于治疗已经接受过雄激素受体通路抑制剂和紫杉烷类药物化疗的前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）成人患者。同时公告显示，该产品已投入研发费用约2332.5万元。 不同于云南白药通过外部合作与自研将两个产品推入临床阶段，另一中药头部公司康缘药业步子迈得更大。不仅是已经推进多款1类化药、生物药进入临床试验，康缘在2024年中直接豪掷2.7亿元收购中新医药，也“跨界”到了布局GLP-1药物。 据此前公告，彼时中新医药有4个临床阶段的创新药，包括长效GLP-1/GIP/GCG三重受体激动剂ZX-2021，和长效GLP-1/GIP双重受体激动剂ZX-2010两款GLP-1产品。 在2024年被华润三九收入麾下的天士力算得上是国内细胞治疗领域的种子选手。今年3月时，其自主研发的同种异体脂肪间充质基质细胞注射液（NR-20201）获得NMPA批准该药物用于治疗急性缺血性脑卒中，此前NR-20201已在美国获批开展临床试验。 另一款与首都医科大学附属北京神经外科研究所联合开发的‌P134细胞注射液也‌获批IND，拟用于治疗‌复发胶质母细胞瘤（GBM）‌。值得注意的是，这是我国首款针对CD44/CD133双靶点的自体CAR-T疗法。 不难看出，中药龙头们的跨界更加注重协同性。在不打乱既有主业节奏、不强融研发体系，不抛弃传统品牌的基础上，搭建出另一条创新药的平行系统，以此形成可控的“能力升级”，重点发挥自己的市场化能力与品牌资产，既避免技术风险，又保留商业化能力。在原有边界之外不断圈地，尝试“第二增长曲线”的建立。 华润三九们的跨界逻辑，或许也会是未来更多中药企业效仿的解法。 其实万变不离其宗的是，不论是中药企业跨界到创新药，还是创新药进入中药赛道，最终还是要回归到药物能否进入临床、被医生接受、被患者有效使用。对华润三九来说，它拥有渠道与品牌，但在创新药时代，能否建立医学学术能力、临床路径资源、准入支付能力，才是决定这些“新业务”能否成为“新增长”的核心。 对于一家在中药赛道里狂奔数十年的企业而言，跨界不一定意味着换道，但它一定意味着：一个更复杂但也更有机会的未来不远了。 一审| 黄佳 二审| 李芳晨 三审| 李静芝 精彩推荐 大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆 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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/.

外资创新PCSK9抑制剂的提前“退出”，或许只是开始… 撰文| 一票人马 本土创新药“围剿”之下，中国市场，迎来了首个PCSK9降脂药的主动“撤退”。 一则“关于波立达 (阿利西尤单抗注射液)的告知函”在业界传播，主体内容是赛诺菲宣布将终止明星新型降脂药——波立达在中国市场的推广。距离该药在华上市，不过5年左右的时间。 结合赛诺菲告知函内容，此番“撤离”离不开多方因素考量，主要系三点：伴随更多国产PCSK9抑制剂纳入医保，竞争加剧；原料供应形势紧张，产能供不上；内部心血管管线调整，转而聚焦其它心血管新药的上市工作。 PCSK9赛道，目前中国市场已形成“3+4”竞争格局：3款进口药，来自安进、赛诺菲和诺华；4款本土创新药，均于近3年获批，且背后均为中国创新第一梯队的明星药企。 竞争者们，干劲正十足，一边给出更具吸引力的费用方案，另一边提速进军广泛的基层市场。而今年的医保席位争夺，也必将是一出大戏。 急速改变的竞争环境，叠加产能供应紧张等因素，让在其中者打响了“撤离”第一枪。但这一决定，对于诸多产业人士来说，仍旧“快得猝不及防”。 首个PCSK9“撤退” 今年的医保谈判还未拉开帷幕，属于PCSK9的医保擂台赛，赛诺菲选择先“撤”了。 这一决定，是基于医保竞争加剧、市场环境变化及产品长期存在的供应问题等综合考量。 据药融圈数据库，截至2024年，波立达在医院全终端（含基层医疗）的销售额达8.5亿元，市占率第二。安进的依洛尤单抗以13.8亿元的销售额拿下了60.4%的市场占有率。同期，后上市的两款产品——诺华英克司兰与信达托莱西单抗，分别只有2.14%与0.15%的市占率。 这样来看，波立达并非被“压的喘不过气来”。为何在此时选择退出？ 可能要从PCSK9诱人的市场与呼之欲出的“卷生卷死”说起。 《中国心血管健康与疾病报告2022》显示，我国心血管病患者达3.3亿，包括脑卒中1300万、冠心病1139万。其中降低低密度脂蛋白胆固醇（LDL-C）水平在众多可干预的心血管疾病风险因素中，被认为是最重要且有效的手段之一。 在现有降LDL-C的降脂药中，他汀类药物占据主导地位。然而，即便他汀类药物剂量增倍，LDC-C降低效果只增加6%，并且存在潜在的副作用，很多患者对他汀类药物存在不耐受，可能出现肝功能损伤、肌痛、横纹肌溶解等不良反应。有相当比例患者在接受他汀类药物治疗后效果未能达标。因此，对于已进行生活方式干预并且他汀类药物达最大耐受剂量仍无法使 LDL-C 达标的患者，需要选择联合非他汀药物治疗。 PCSK9抑制剂作为一种新型、强效且副作用较小的降脂药物，被认为是“后他汀时代”最强大的降脂新药，联合他汀药物治疗可以使LDL-C比单独使用他汀类药物治疗降低50%-60%。 弗若斯特沙利文报告显示，中国PCSK9药物市场将于2030年达到89亿元，2022到2030年的复合增长率为43.5%。 但PCSK9在国内的竞争格局，堪称“修罗场”，已经聚齐了单抗、siRNA、长效剂型、基因编辑等多种技术路径。 当然，卷技术只是其中之一，产品价格、医保席位和院内外市场的激烈争夺战，也已经开始。 作为全球最早上市的PCSK9单抗，波立达2015年在美获批，2019年被NMPA纳入创新药优先审评名单目录，2020年获得加速批准上市，上市第二年进入到了医保目录。上市之初，波立达定价1982元/支，在2021年进入医保后，降价至306元/支。 2023年之前，PCSK9是属于安进与赛诺菲两厢对决的赛场。两家公司的专利战从波立达上市前就开始了纷争，官司打了近十年，直到2023年才告一段落。 这种“单挑”的日子，没能持续多久。2023年8月，PCSK9界迎来两大新选手：诺华与信达。 外资企业开启“三强争霸战”的同时，信达的托莱西单抗“杀”了出来，成为首个获批上市的国产重组全人源抗 PCSK9 单抗，用于治疗高胆固醇血症或血脂异常患者。 由于安进与赛诺菲的产品早已进入医保目录，所以2024年的医保谈判，市场将目光聚焦于信达与诺华。信达的托莱西单抗进入医保后，降价至每针不到300元，与安进的依洛尤单抗、赛诺菲的波立达开始瓜分市场。 但PCSK9的战事愈发提速，到了2025年，战局又变得大不一样。 除了医保内的安进、赛诺菲、与信达，再加上小核酸药物英克司兰，PCSK9这条路上，一下子又多了三个国内的劲敌：康方的伊努西单抗、君实的昂戈瑞西单抗和恒瑞的瑞卡西单抗。 2025年医保谈判在即，这下，不再是信达单枪匹马挑战MNC了，而颇有多方国产创新药“围剿”的意味。 对于这一次跨国药企创新药的“撤退”，有分析认为“没想到这么快”。在医保目录的快速调整、市场格局剧变以及供应问题的多重夹击下，赛诺菲战略性放弃在中国市场处境将更加艰难的波立达，也无可厚非。  推荐阅读  * 找华润、上药、国药做“外包”，辉瑞、赛诺菲、BI们的盘算与算盘 * AZ登顶，诺华降速，默沙东跌70%！MNC中国区为何猛“刹车”？ “变阵” 值得一提的是，波立达并非赛诺菲在中国市场作出战略调整的首个创新产品。 2023年底，赛诺菲与上药控股达成合作，后者通过全国全渠道CSO服务，为赛诺菲中国多个药品（包括但不限于心血管疾病、中枢神经系统疾病、肿瘤等领域产品）推进本土商业化，但在赛诺菲心血管管线中，还有一款在中国上市不久的复方降脂药物——瑞舒伐他汀依折麦布片（旨立达）。 波立达与旨立达两款产品的“撤退”，背后反映的是赛诺菲在中国市场不得不直面的现实：2025年上半年，尽管全球销售额同比增长8.3%，达到198.9亿欧元，中国市场收入却仅为13.88亿欧元，增幅仅0.1%。 这意味着，如果说在全球市场，度普利尤单抗仍能独撑大局，那么在中国市场，这一支点已接近极限。 赛诺菲对这一困境早有预判。自2019年其心血管核心产品波立维（氯吡格雷）在“4+7”带量采购扩围中以17.81元/盒的价格中标后，公司便开始通过引进新产品，尝试构建新的增长支撑点。 2019年，波立达获NMPA批准上市；2022年，多立维（氯吡格雷阿司匹林片）作为波立维的“升级版”进入中国市场；2023年，旨立达（瑞舒伐他汀依折麦布片）获批，用于治疗高胆固醇血症及HoFH患者。与此同时，赛诺菲在中国的心血管产品线还包括原研厄贝沙坦、厄贝沙坦氢氯噻嗪以及原研抗凝药依诺肝素钠注射液，几乎覆盖了抗板、降脂、降压及房颤等多个细分领域。 然而，即便拥有如此完整的心血管治疗管线和全球明星产品度普利尤单抗的加持，赛诺菲在中国的业绩增速自2023年起却持续低迷，甚至跌破1%。 来源：企业财报 更值得关注的是，旨立达虽在2023年才获批上市，但其仿制药2024年便已提交上市申请。2025年4月，北京福元医药的国内首仿产品正式获批，赛诺菲在该产品的独占期迅速受到挑战。 面对增长乏力与产品竞争加剧的双重压力，赛诺菲其实早已难以复制当年原研氯吡格雷、原研厄贝沙坦氢氯噻嗪等逆势中标集采的策略。 这也意味着，赛诺菲必须重新审视自身的产品组合策略——不仅要持续引进高质量创新药，还需在开拓新增量与逐渐边缘化的存量品种之间果断取舍。 因此，2024年底，赛诺菲CV事业部停止推广波立达与旨立达；2025年，旨立达转交上药推广，波立达则正式退出中国市场。 与此同时，赛诺菲也开启了一轮密集的外部合作： 2024年12月，赛诺菲与箕星药业达成协议，收购其在大中华区用于治疗症状性非梗阻性肥厚型心肌病（nHCM）产品aficamten的开发与商业化权益； 此后，又与Arrowhead旗下维亚臻签署合作协议，获得在中国市场开发与商业化plozasiran（VSA001）的独家权利。这是一款靶向APOC3的siRNA疗法，被寄望于治疗家族性乳糜微粒血症（FCS）与重度高甘油三酯血症（SHTG），具备“first-in-class”潜力。 在组织层面，赛诺菲的调整也同步推进。自2020年起，公司为与全球架构对齐，重组中国区业务为特药、普药和疫苗三大业务单元，并调整负责人；随后又在2025年推动医学团队整合，将大中华区的普药与特药医学团队合并，统一向全球普药事业部医学部汇报。 但现实仍然严峻。在传统产品峰值已至、新产品放量缓慢，以及中国心血管市场竞争全面加剧的内外部压力下，赛诺菲在中国的下一步——如何突破增长瓶颈、能否重拾业绩弹性——仍悬而未决。 或许，赛诺菲心血管业务与“变阵”的故事，才刚刚开始。 一审| 黄佳 二审| 李芳晨 三审| 李静芝 精彩推荐 大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆 大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药 创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹 跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳 供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星 启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册