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生物技术投资成为美中贸易战的新前线Biotech investment is the new front in the U.S.-China trade fight

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美国财政部周四提出新规,旨在限制美国对中国生物技术领域的投资——正值美国制药商越来越多地转向这个蓬勃发展的行业,以开发其下一代重磅产品。

The Treasury Department proposed new rules Thursday to curb U.S. investment in Chinese biotechnology – just as American drugmakers have been increasingly turning to the booming sector to develop their next blockbuster products.

该提案若最终确定,将成为针对制药行业外国投资的首项限制措施,禁止涉及“某些生物衍生化合物或材料”、生物制造设备和设施,以及与生物设计和测序相关的技术的交易。它还禁止对用于“自动化科学发现或实验”的软件或设备进行投资。脑机接口和生物信息学工具也将受到投资禁令约束。

The proposal, which if finalized would be the first restrictions on foreign investment in the pharmaceutical industry, prohibits transactions covering “certain bio-derived compounds or materials,” biomanufacturing equipment and facilities, and technology related to biological design and sequencing. It also bans investment in software or equipment for “automated scientific discovery or experimentation.”Brain-computer interfaces and bioinformatics tools would also be subject to the investment prohibition.

主要制药商的游说团体美国药研制造商协会(PhRMA)一直主张不应限制对华投资和交易,理由是这不会减缓北京生物技术行业的发展。

PhRMA, the lobbying group for major drugmakers, has advocated against limits on investment and dealmaking in China, arguing they won’t slow down Beijing’s biotech sector.

“美国患者希望尽快获得最前沿的治疗,而当前的生态系统包含大量来自中国的有前景的科学成果,”PhRMA政策与研究副总裁乔斯林·乌尔里希(Jocelyn Ulrich)对《政治报》(POLITICO)表示。

“American patients want to have access to the most cutting-edge treatments as quickly as possible, and the ecosystem includes a lot of promising science from China right now,” Jocelyn Ulrich, PhRMA’s vice president for policy and research, told POLITICO.

去年12月通过的立法扩大了对位于“关注国家”(包括中国)的敏感技术和行业的美国投资限制。财政部有酌情权将生物技术列入清单,规定某些投资交易要么被禁止,要么须向该部门报告。

Legislation passed in December expanded limits on U.S. investment into sensitive technologies and industries located in “countries of concern,” including China. Treasury has the discretion to add biotech to the list of sectors for which certain investment transactions are either prohibited or required to be reported to the department.

一些议员和对华强硬派一直在推动特朗普政府遏制美国资本涌向东方,理由是北京明确提出到2030年主导全球生物技术的目标。全球在研新药中有三分之一源自中国。

Some lawmakers and China hawks have been pushing the Trump administration to clamp down on American capital surging eastward given Beijing’s stated goal of dominating global biotech by 2030. A third of new drugs under development globally originate in China.

财政部的提议是在制药行业针对严格的投资限制进行了数月的游说推动后提出的。制药巨头和生物技术投资者越来越多地转向中国药企开发商,以补充产品管线并为有前景的早期分子提供资金,辉瑞、百时美施贵宝和罗氏等公司今年已与中国企业达成了数十亿美元的许可交易。

Treasury's proposal comes after a months-long lobbying push by the drug industry against stringent investment restrictions. Pharma giants and biotech investors have increasingly turned to Chinese drug developers to replenish product pipelines and to finance promising early-stage molecules, with companies like Pfizer, Bristol Myers Squibb and Roche striking multibillion-dollar licensing deals this year with Chinese firms.

一些协议包含条款,允许跨国公司和中国企业共同开发和商业化药物候选物 —— 这些药物开发领域对北京在全球生物技术领域占据主导地位的目标至关重要。

Some agreements include terms allowing the multinational companies and the Chinese firms to develop and commercialize the drug candidates together — areas of drug development that are crucial to Beijing’s goal of dominating the biotech sector globally.

一位财政部官员周四告诉记者,该规则不涉及许可交易。该官员拒绝澄清该规则是否以及如何适用于共同开发和共同营销协议。

The rule doesn’t address licensing deals, a Treasury official told reporters Thursday. The official declined to clarify whether or how it would apply to co-development and co-marketing agreements.

根据法律,财政部的这项举措必须在3月前最终确定,此举也紧随中国政府收紧生物制药技术出口监管框架的举措之后,旨在最大化中国相对于外国竞争对手的竞争优势。

The Treasury initiative, which by law must be finalized by March, also follows moves by the Chinese government to tighten its export regulatory framework for biopharma technologies to maximize China’s competitive edge against foreign rivals.

中国商务部上周在一份声明中表示,北京提议禁止向外国买家出售生物制药创新成果,包括国内细胞和基因疗法技术。声明称,拟议规则将把外国获取途径限制在许可协议上,这些协议镜像了其他主要经济体的限制,但不会妨碍“正常国际科技交流合作”。

Beijing has proposed a ban on the sale to foreign buyers of biopharma innovations, including domestic cell-and-gene therapy technologies, China’s Ministry of Commerce said in a statement last week. The proposed rules will instead limit foreign access to licensing agreements that mirror restrictions by other major economies but won’t hamper “normal international technological exchange cooperation,” the statement said.

一位获准匿名以便坦率发言的美国制药行业游说人士表示,中国的提议似乎给了北京“一些筹码……以便在必要时进行报复”,如果华盛顿针对生物技术交易实施更严格的限制。

A U.S. drug industry lobbyist, granted anonymity to speak candidly, said China’s proposal appeared to give Beijing “some levers … so that they are then ready to retaliate if they need to,” if Washington targeted biotech deals for greater restrictions.

美国和中国的监管举措凸显了北京和华盛顿如何将跨境生物制药投资视为对药品等基本材料和产品供应链稳定性的潜在威胁。

The U.S. and Chinese regulatory moves underscore how Beijing and Washington view cross-border biopharma investment as a potential threat to the stability of supply chains for essential materials and products like medicines.

特朗普政府希望避免制造新的供应链脆弱性,因为它正争分夺秒地减少对中国关键矿产全球垄断的依赖,而北京去年在美中贸易战中将其武器化。中国领导人习近平于2022年发起了一场运动,旨在让中国摆脱对外国技术和进口产品的依赖,因为这些可能成为未来贸易争端中的压力点。

The Trump administration wants to avoid creating new supply chain vulnerabilities as it scrambles to reduce its dependence on China’s global monopoly of critical minerals, which Beijing weaponized in the U.S.-China trade war last year. China’s leader, Xi Jinping, launched a campaign in 2022to wean the country from dependence on foreign tech and imports that could become pressure points in future trade disputes.

北京提出的生物技术出口限制是一揽子新限制措施的一部分,该措施还涉及对一些人工智能和光伏技术的外销进行限制,这些技术对太阳能电池板至关重要。这些举措凸显了北京决心通过限制潜在外国竞争对手获取国内创新成果,来主导快速发展的生物制药行业。

Beijing’s proposed biotech export curbs were part of a package of new restrictions on the foreign sale of some artificial intelligence and photovoltaic technologies essential to solar panels. And they underscore Beijing’s determination to dominate the rapidly developing biopharma sector by limiting access to domestic innovations to potential foreign competitors.

“这符合近期在工业和技术安全大旗下,收紧技术出口、对外投资和数据管控,以及人员——人才和资本外流限制——的更广泛模式,”外交关系协会中国卫生政治专家黄严忠表示。

“It fits a broader recent pattern of tightening controls over technology exports, outbound investment and data, and people — talent and capital exit restrictions — all under the banner of industrial and technological security,” said Yanzhong Huang, an expert on Chinese health politics at the Council on Foreign Relations.

这与北京的目标一致——该目标载于上月发布的中国医药工业新“五年规划”中——即将其生物制药行业培育成为与半导体、电池和机器人齐名的“国家支柱产业”。习近平已将包括生物制药在内的“未来产业发展”确立为其政府超越美国和欧盟等传统外国技术竞争对手的核心驱动力。

That aligns with Beijing’s objective — spelled out in a new five-year plan for China’s pharmaceutical industry released last month — to groom its biopharma sector into becoming a “national pillar industry” along with semiconductors, electrical batteries and robotics. Jinping has made “the development of industries of the future” including biopharma a centerpiece of his government’s drive to outpace traditional foreign tech rivals including the U.S. and the European Union.

“主导逻辑是战略性地保留核心能力,”黄说。禁止外资持股“防止基础知识产权的‘连根拔起’式转移,同时仍允许企业将其货币化。”两党议员今年都推动立法,将生物技术纳入12月法律(即《COINS法案》)覆盖的行业。密歇根州共和党众议员、众议院中国问题特别委员会主席约翰·莫伦纳尔曾敦促财政部长斯科特·贝森特将生物技术列为禁止技术,并审查许可和商业化交易等交易。

“The dominant logic is strategic retention of core capabilities,” said Huang. Barring foreign ownership “prevents ‘uprooting’ transfers of foundational intellectual property while still allowing firms to monetize them.”Members of both parties have pushed legislation this year to make biotech a sector covered by the December law, known as the COINS Act. Michigan Republican John Moolenaar, chair of the House’s select committee on China, has urged Treasury Secretary Scott Bessent to make biotech a prohibited technology and to scrutinize licensing and commercialization deals, among other transactions.

美国制药研究和制造商协会的乌尔里希表示,迄今为止的大多数交易仍是许可安排,即美国公司控制分子,而中国公司保留为中国患者开发药物的权利。

Ulrich at PhRMA said most deals to date remain licensing arrangements in which the American company controls the molecule while the Chinese firm retains the rights to develop the drug for patients in China.

“只要美国公司能够在美国开发、进行临床试验,并通过FDA流程将其推向市场,我们就不认为这存在国家安全担忧,”乌尔里希说。

“As long as U.S. companies are able to develop, run clinical trials in America, and bring it through the FDA process, we don't see that there is a national security concern with that,” Ulrich said.

该行业反而敦促政府采取更多措施,使美国行业更具竞争力,例如加快国内早期临床试验启动的流程。卫生与公众服务部于6月宣布了此类努力,称为“Operation Trialblazer”(试验先锋行动)。

The industry has instead urged the administration to do more to make the U.S. sector more competitive, such as speeding up the process for launching early-stage clinical trials domestically. The Department of Health and Human Services announced such an effort, dubbed “Operation Trialblazer,” in June.

生物技术创新组织首席执行官约翰·克劳利5月对记者谈到投资限制时说:“我只觉得这太简单化了。我认为,试图限制资本外流或技术内流,其效果可能不像人们想象的那么显著。”“如果中国实验室研发出治疗罕见儿童癌症的药物,我们怎么能告诉美国公民、美国公司,你们不能碰那个?”他补充道。财政部将就该提案征求公众意见,截止日期为12月7日。

“I just think it's too simplistic,” John Crowley, CEO of the Biotechnology Innovation Organization, told reporters in May of investment limits. “I think the effectiveness may not be as significant as people think by trying to restrict outbound flows of capital or inbound flows of technology.”“If a Chinese lab comes up with a cure to a rare pediatric cancer, how in the world do we tell American citizens, American companies, you can't touch that?” he added. Treasury will take public comment on the proposal until Dec. 7.

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