纽约时报中文网 - 中英对照版-中英中国药企药明康德成美国国会打击目标

A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity and debilitating illnesses like cystic fibrosis.

由于与中国政府的潜在关系，一家为美国市场生产重磅药物的中国公司成为了国会议员的攻击目标。这家公司生产的药物被认为在癌症、肥胖症以及囊性纤维化等严重损伤身体的疾病方面取得了重大进展。

WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them.

立法者已经认定多家公司对美国人的个人基因信息和美国知识产权构成潜在的安全威胁，药明康德便是其中之一。参议院的一个委员会在今年3月通过了一项议案，助手们称该议案的目的是推动美国企业停止与这些中国公司做生意。

But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope work WuXi does for the U.S. biotech and pharmaceutical industries — and patients. A New York Times review of hundreds of pages of records worldwide shows that WuXi is heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and H.I.V.

但在参议院和众议院的听证会上讨论该议案时，议员们几乎只字不提药明康德为美国生物技术和制药行业（以及患者）所做的广泛工作。《纽约时报》查看了来自世界各地的数以百计页数的记录，这些文件显示，美国人用的许多药都离不开药明康德，这家公司为美国市场上销售额高达数十亿美元的药物生产部分或全部主要成分，包括广泛用于某些类型的白血病和淋巴瘤等癌症，以及肥胖症和艾滋病毒的治疗药物。

The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high. Some biotech executives have pushed back, trying to impress on Congress that a sudden decoupling could take some drugs out of the pipeline for years.

美国国会对药明康德的关注让制药行业感到不安，该行业已经面临广泛的药品短缺问题，目前处于20年来的最严重程度。生物技术行业的一些高管已表示反对这项议案，他们试图让国会意识到，突然脱钩可能会导致一些药物的研发出现数年延迟。

WuXi AppTec and an affiliated company, WuXi Biologics grew rapidly, offering services to major U.S. drugmakers that were seeking to shed costs and had shifted most manufacturing overseas in the last several decades.

药明康德及其一家子公司药明生物的快速发展源自为美国的主要制药商提供服务。为了削减成本，美国制药商已在过去几十年里将大部分生产转移到海外。

WuXi companies developed a reputation for low-cost and reliable work by thousands of chemists who could create new molecules and operate complex equipment to make them in bulk. By one estimate, WuXi has been involved in developing one-fourth of the drugs used in the United States. WuXi AppTec reported earning about $3.6 billion in revenue for its U.S. work.

药明系有成本低、产品可靠的声誉，并雇佣了数以千计的化学家，他们能开发新分子并操作批量生产它们的复杂设备。据估计，药明康德参与了美国四分之一药物的研发。药明康德的财报称，公司的美国业务带来36亿美元左右的收入。

“They have become a one-stop shop to a biotech,” said Kevin Lustig, founder of Scientist.com, a clearinghouse that matches drug companies seeking research help with contractors like WuXi.

“它们已成为生物技术领域的全方位供应商，”凯文·卢斯蒂格说，他创建了为寻求研发帮助的制药公司与药明康德等承包商牵线搭桥的信息交换所Scientist.com。

WuXi AppTec and WuXi Biologics have also received millions of dollars in tax incentives to build sprawling research and manufacturing sites in Massachusetts and Delaware that local government officials have welcomed as job and revenue generators. One WuXi site in Philadelphia was working alongside a U.S. biotech firm to give patients a cutting-edge therapy that would turbocharge their immune cells to treat advanced skin cancers.

药明康德和药明生物还获得了数以百万计美元的税收优惠，在马萨诸塞州和特拉华州建立了大型研发和生产基地，由于能创造就业和收入，这些基地受到了当地政府官员的欢迎。药明康德设在费城的一个部门正在与一家美国生物技术公司合作，为晚期皮肤癌患者提供增强免疫细胞抗癌能力的尖端疗法。

The tension has grown since February, when four lawmakers asked the Commerce, Defense and Treasury Departments to investigate WuXi AppTec and affiliated companies, calling WuXi a “giant that threatens U.S. intellectual property and national security.”

紧张状况自今年2月以来已在加剧。四名国会议员曾在当月要求美国商务部、国防部和财政部调查药明系企业，他们把药明康德称为“威胁美国知识产权和国家安全的巨型企业”。

A House bill called the Biosecure Act linked the company to the People’s Liberation Army, the military arm of the Chinese Communist Party. The bill claims WuXi AppTec sponsored military-civil events and received military-civil fusion funding.

众议院的《生物安全法案》将药明康德与中共军事机构中国人民解放军联系起来，声称药明康德赞助过军民活动，得到过军民融合资金。

Richard Connell, the chief operating officer of WuXi AppTec in the United States and Europe, said the company participates in community events, which do not “imply any association with or endorsement of a government institution, political party or policy such as military-civil fusion.” He also said shareholders do not have control over the company or access to nonpublic information.

药明康德的美国和欧洲首席运营官理查德·康奈尔说，公司参与社区活动并不“意味着与政府机构、政党或军民融合等政策有任何联系，或对政府机构、政党或军民融合等政策表示认可”。他还说，股东对公司没有控制，也不获取公司的非公开信息。

Last month, after a classified briefing with intelligence staff, the Senate homeland security committee advanced a bill by a vote of 11 to 1: It would bar the U.S. government from contracting with companies that work with WuXi. Government contracts with drugmakers are generally limited, though they were worth billions of dollars in revenue to companies that responded to the Covid-19 pandemic.

上个月，参议院国土安全委员会闭门听取了情报人员的情况介绍，之后以11票支持、一票反对通过了一项议案：禁止美国政府与与药明康德合作的公司签订合同。虽然政府与制药商签的合同通常涉及的数额有限，但它们曾为对新冠病毒大流行做出响应的公司带来了数十亿美元的收入。

Mr. Connell defended the company’s record, saying the proposed legislation “relies on misleading allegations and inaccurate assertions against our company.”

康奈尔为药明康德的过往记录做辩护说，拟议的立法“基于的是针对我们公司的误导性指控和不准确认定”。

WuXi operates in a highly regulated environment by “multiple U.S. federal agencies — none of which has placed our company on any sanctions list or designated it as posing a national security risk,” Mr. Connell said. WuXi Biologics did not respond to requests for comment.

药明康德在一个受“多个美国联邦机构高度监管”的环境中运营，康奈尔说，“没有一个机构将我们公司列入任何制裁名单，或将其认定为构成国家安全风险”。药明生物没有回复记者的置评请求。

Smaller biotech companies, which tend to rely on government grants and have fewer reserves, are among the most alarmed. Dr. Jonathan Kil, the chief executive of Seattle-based Sound Pharmaceuticals, said WuXi has worked alongside the company for 16 years to develop a treatment for hearing loss and tinnitus, or ringing in the ear. Finding another contractor to make the drug could set the company back two years, he said.

对国会的关注最担心的是规模更小的生物技术公司，它们往往依赖政府拨款，而且资金储备更少。总部位于西雅图的Sound Pharmaceuticals的首席执行官乔纳森·基尔博士说，公司已在研发治疗听力损失和耳鸣的药物上与药明康德进行了16年的合作。寻找另一家承包商来生产这种药物可能会将公司的生产推迟两年，他说。

“What I don’t want to see is that we get very anti-Chinese to the point where we’re not thinking correctly,” Dr. Kil said.

“我不希望看到我们如此反对中国，以至于不能正确地思考，”基尔说。

It is unclear whether a bill targeting WuXi will advance at all this year. The Senate version has been amended to protect existing contracts and limit supply disruptions. Still, the scrutiny has prompted some drug and biotechnology companies to begin making backup plans.

目前尚不清楚针对药明康德的议案今年是否会推进。为了保护现有合同并限制供应方面受到的中断，参议院版本的议案已经过修改。尽管如此，这种审查还是促使一些制药和生物技术公司开始制定后备计划。

Peter Kolchinsky, managing partner of RA Capital Management, estimated that half of the 200 biotech companies in his firm’s investment portfolio work with WuXi.

RA资本的执行合伙人彼得·科尔钦斯基估计，其公司投资组合中的200家生物科技公司中有一半与药明康德存在合作关系。

“Everyone is likely considering moving away from Wuxi and China more broadly,” he said in an email. “Even though the current versions of the bill don’t create that imperative clearly, no one wants to be caught flat-footed in China if the pullback from China accelerates.”

“每个人都可能在考虑从药明康德和中国撤离，”他在一封电子邮件中表示。“尽管该议案目前的版本并未明确提出这一要求，但如果从中国的撤出速度加快，没有人愿意被打个措手不及。”

The chill toward China extends beyond drugmakers. U.S. companies are receiving billions of dollars in funding under the CHIPS Act, a federal law aimed at bringing semiconductor manufacturing stateside.

针对中国的寒意不仅限于药企。根据《芯片法案》，美国企业正在获得数十亿美元的资金。这是一项联邦法律，旨在将半导体制造转移到美国本土。

For the last several years, U.S. intelligence agencies have been warning about Chinese biotech companies in general and WuXi in particular. The National Counterintelligence and Security Center, the arm of the intelligence community charged with warning companies about national security issues, raised alarms about WuXi’s acquisition of NextCODE, an American genomic data company.

过去几年，美国情报机构一直就中国生物科技公司（特别是药明康德）发出警告。负责就国家安全问题向企业发出警告的情报机构——国家反情报与安全中心对药明康德收购美国基因组数据公司NextCODE提出了担忧。

Though WuXi later spun off that company, a U.S. official said the government remains skeptical of WuXi’s corporate structure, noting that some independent entities have overlapping management and that there were other signs of the Chinese government’s continuing control or influence over WuXi.

尽管药明康德后来剥离了该公司，但一名美国官员表示，政府仍然对药明康德的公司架构持怀疑态度，并指出一些独立实体的管理存在重叠，而且还有其他迹象表明，中国政府继续控制或对药明康德施加影响。

Aides from the Senate homeland security committee said their core concerns are about the misuse of Americans’ genomic data, an issue that’s been more closely tied to other companies named in the bill.

参议院国土安全委员会的助手表示，他们的核心担忧是美国人的基因组数据遭到滥用，这一问题与该法案中点名的其他公司更为密切相关。

Aides said the effort to discourage companies from working with WuXi and others was influenced by the U.S. government’s experience with Huawei, a Chinese telecommunications giant. By the time Congress acted on concerns about Huawei’s access to Americans’ private information, taxpayers had to pay billions of dollars to tear Huawei’s telecommunication equipment out of the ground.

这些助手表示，阻止企业与药明康德等公司合作的努力受到了美国政府在中国电信巨头华为一事上经验的影响。在国会就华为获取美国人私人信息的担忧采取行动时，纳税人不得不支付数十亿美元拆除华为的电信设备。

Yet WuXi has far deeper involvement in American health care than has been discussed in Congress. Supply chain analytics firms QYOBO and Pharm3r, and some public records, show that WuXi and its affiliates have made the active ingredients for critical drugs.

然而，药明康德在美国医疗保健领域的参与程度之深，远超国会的讨论。供应链分析公司QYOBO和Pharm3r以及一些公开记录显示，药明康德及其附属公司一直在生产关键药物的活性成分。

They include Imbruvica, a leukemia treatment sold by Janssen Biotech and AbbVie that brought in $5.9 billion in worldwide revenue in 2023. WuXi subsidiary factories in Shanghai and Changzhou were listed in government records as makers of the drug’s core ingredient, ibrutinib.

这些药物包括由杨森生物技术公司和艾伯维公司销售的一种白血病治疗药物Imbruvica，该药2023年在全球销售额达59亿美元。药明康德位于上海和常州的子公司工厂被列为该药物核心成分伊布替尼的生产商。

Dr. Mikkael A. Sekeres, chief of hematology at the University of Miami Health System, called that treatment for chronic lymphocytic leukemia “truly revolutionary” for replacing highly toxic drugs and extending patients’ lives.

迈阿密大学卫生系统血液学主任米凯尔·希格斯表示，对于替代毒性极大的药物和延长患者生命来说，这种药物对慢性淋巴细胞白血病的治疗是“真正革命性的”。

Janssen Biotech and AbbVie, partners in selling the drug, declined to comment.

该药物的销售合作伙伴杨森和艾伯维拒绝发表评论。

WuXi Biologics also manufactures Jemperli, a GSK treatment approved by the Food and Drug Administration last year for some endometrial cancers. In combination with standard therapies, the drug improves survival in patients with advanced disease, said Dr. Amanda Nickles Fader, president of the Society of Gynecologic Oncology.

药明生物还生产Jemperli，该药用于治疗某些子宫内膜癌，由葛兰素史克研发，去年得到了FDA批准。妇科肿瘤学会主席阿曼达·尼克尔斯·法德表示，与标准疗法结合使用，该药物可以提高晚期疾病患者的生存率。

“This is particularly important because while most cancers are plateauing or decreasing in incidence and mortality, endometrial cancer is one of the only cancers globally” increasing in both, Dr. Fader said.

“这一点尤其重要，因为虽然大多数癌症的发病率和死亡率都趋于稳定或下降，但子宫内膜癌是全球少数”在这两个方面“都在增加的癌症之一”，法德说。

GSK declined to comment.

葛兰素史克拒绝置评。

The drug that possibly captures WuXi’s most significant impact is Trikafta, manufactured by an affiliate in Shanghai and Changzhou to treat cystic fibrosis, a deadly disease that clogs the lungs with debilitating, thick mucus. The treatment is credited with clearing the lungs and extending by decades the life expectancy of about 40,000 U.S. residents. It also had manufacturers in Italy, Portugal and Spain.

药明康德影响最大的药物恐怕要属Trikafta了，它是由上海和常州的一家子公司生产的，用于治疗囊性纤维化，这种致命疾病会用令人日渐衰弱的浓稠粘液堵塞肺部。该治疗据信可以让肺部畅通，并将大约4万名美国居民的预期寿命延长数十年。该药物还在意大利、葡萄牙和西班牙生产。

The treatment has been so effective that the Make-A-Wish Foundation stopped uniformly granting wishes to children with cystic fibrosis. Trikafta costs about $320,000 a year per patient and has been a boon for Boston-based Vertex Pharmaceuticals and its shareholders, with worldwide revenue rising to $8.9 billion last year from $5.7 billion in 2021, according to a securities filing.

这种疗法非常有效，以至于“许愿基金会”不再统一为患有囊性纤维化的儿童实现愿望。根据一份证券备案文件，每年每位患者使用Trikafta费用约为32万美元，令总部位于波士顿的福泰制药公司及其股东大为受益，其全球收入从2021年的57亿美元增至去年的89亿美元。

Trikafta “completely transformed cystic fibrosis and did it very quickly,” said Dr. Meghan McGarry, a University of California San Francisco pulmonologist who treats children with the condition. “People came off oxygen and from being hospitalized all the time to not being hospitalized and being able to get a job, go to school and start a family.”

Trikafta“以非常快的速度彻底改变了囊性纤维化”，加州大学旧金山分校的肺科医生梅格汉·麦克格雷说，他负责治疗患有这种疾病的儿童。“人们不再需要吸氧，不再需要一直住院，而是能够找到工作、上学并组建家庭。”

Vertex declined to comment.

福泰制药拒绝发表评论。

Two industry sources said WuXi plays a role in making Eli Lilly’s popular obesity drugs. Eli Lilly did not respond to requests for comment. WuXi companies also make an infusion for treatment-resistant H.I.V., a drug for advanced ovarian cancer and a therapy for adults with a rare disorder called Pompe disease.

两位行业消息人士称，药明康德参与了礼来公司广受欢迎的肥胖症药物的生产。礼来公司没有回应置评请求。药明康德还生产一种治疗耐药性艾滋病的输液药物、一种治疗晚期卵巢癌的药物，以及一种治疗得了罕见庞贝氏症的成年人的药物。

WuXi is known for helping biotech firms from the idea stage to mass production, Dr. Kolchinsky said. For example, a start-up could hypothesize that a molecule that sticks to a certain protein might cure a disease. The company would then hire WuXi chemists to create or find the molecule and test it in petri dishes and animals to see whether the idea works — and whether it’s safe enough for humans.

科尔钦斯基说，药明康德以帮助生物技术公司从创意阶段走向量产而闻名。例如，一家初创公司可能会设想一种能粘附在某种蛋白质上的分子能够治愈某种疾病。然后，这家公司会聘请药明康德的化学家来创造或寻找这种分子，并在培养皿和动物身上进行测试，看看这个想法是否有效，以及对人类是否足够安全。

“Your U.S. company has the idea and raises the money and owns the rights to the drug,” Dr. Kolchinsky said. “But they may count on WuXi or similar contractors for almost every step of the process.”

“美国的公司有想法，筹集资金，并拥有药物的专利，”科尔钦斯基说。“但它们可能会依赖药明康德或类似的承包商来完成几乎每一个环节。”

WuXi operates large bioreactors and manufactures complex peptide, immunotherapy and antibody drugs at sprawling plants in China.

药明康德在中国拥有大型生物反应器，并在规模庞大的工厂生产复杂的多肽、免疫疗法和抗体药物。

WuXi AppTec said it has about 1,900 U.S. employees. Officials in Delaware gave the company $19 million in tax funds in 2021 to build a research and drug manufacturing site that is expected to employ about 1,000 people when fully operational next year, public records and company reports show.

药明康德表示，该公司在美国拥有约1900名员工。公共记录和公司报告显示，特拉华州官员在2021年向该公司提供了1900万美元的税收资金，用于建设一个研究和药物生产基地，预计明年全面投入运营后将雇用约1000名员工。

Mayor Kenneth L. Branner Jr. of Middletown, Del., called it “one of those once-in-a-lifetime opportunities to land a company like this,” according to a news report when the deal was approved.

根据交易获得批准时的新闻报道，得克萨斯州米德尔敦市市长肯尼思·布兰纳称这是“一次能吸引这样一家公司千载难逢的机会”。

In 2022, the lieutenant governor of Massachusetts expressed a similar sentiment when workers placed the final steel beam on a WuXi Biologics research and manufacturing plant in Worcester. Government officials had approved roughly $11.5 million in tax breaks to support the project. The company announced this year that it would double the site’s planned manufacturing capacity in response to customer demand.

2022年，当工人们为位于伍斯特的药明康德研究与生产工厂安放最后一根钢梁时，马萨诸塞州副州长也表达了类似的想法。政府官员批准了约1150万美元的税收减免，以支持该项目。该公司今年宣布，为满足客户需求，将把该基地的计划生产能力提高一倍。

And in Philadelphia, a WuXi Advanced Therapies site next to Iovance Biotherapeutics was approved by regulators to help process individualized cell therapies for skin cancer patients. Iovance has said it is capable of meeting demand for the therapies independently.

在费城，与Iovance Biotherapeutics公司相邻的药明康德先进疗法基地已获监管机构批准，帮助处理皮肤癌患者的个体化细胞疗法。Iovance公司表示，它有能力独立满足这种疗法的需求。

By revenue, WuXi Biologics is one of the top five drug development and manufacturing companies worldwide, according to Statista, a data analytics company. A WuXi AppTec annual report showed that two-thirds of its revenue came from U.S. work.

据数据分析公司Statista统计，按收入计算，药明康德是全球五大药物研发和生产公司之一。药明康德的年度报告显示，其三分之二的收入来自美国。

Stepping away from WuXi could cause a “substantial slowdown” in drug development for a majority of the 105 biotech companies surveyed by BioCentury, a trade publication. Just over half said it would be “extremely difficult” to replace China-based drug manufacturers.

在接受行业刊物《生物世纪》调查的105家生物技术公司中，大多数公司认为，脱离药明康德可能会导致药物开发“大幅放缓”。超过半数的公司表示，要取代在中国的药品生产商“极其困难”。

BIO, a trade group for the biotechnology industry, is also surveying its members about the impact of disconnecting from WuXi companies. John F. Crowley, BIO’s president, said the effects would be most difficult for companies that rely on WuXi to manufacture complex drugs at commercial scale. Moving such an operation could take five to seven years.

生物技术行业的贸易团体BIO也在调查其成员与药明康德脱离关系的影响。BIO总裁约翰·克劳利说，对于依赖药明康德以商业规模生产复杂药物的公司来说，这种影响可能最为严重。这种业务的转移可能需要五到七年的时间。

“We have to be very thoughtful about this so that we first do no harm to patients,” Mr. Crowley said. “And that we don’t slow or unnecessarily interfere with the advancement of biomedical research.”

“我们必须非常慎重地对待这个问题，以确保首先不会伤害病人的利益，”克劳利说。“而且可以让我们不减缓或不必要干扰生物医学研究的进展。”