受到美国国会审查的中国公司生产美国关键药品
【中美创新时报2024 年 4 月 16 日编译讯】（记者温友平编译）一家中国公司因与中国政府存在潜在联系而受到美国国会议员的攻击，该公司为美国市场生产重磅药物，这些药物被誉为在治疗癌症、肥胖症和囊性纤维化等衰弱疾病方面取得了很大进展。《纽约时报》记者克里斯蒂娜·朱伊特（Christina Jewett）对此作了下述报道。
药明康德是立法者认定对美国个人基因信息和美国知识产权安全构成潜在威胁的几家公司之一。参议院委员会三月份批准了一项法案，助手们称该法案旨在阻止美国公司与他们开展业务。
但在参议院和众议院讨论该法案的议员们在听证会上几乎没有提及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》对全球数百页记录的审查显示，药明康德在美国药库中占有重要地位，为价值数十亿美元的疗法生产部分或全部主要成分，这些疗法被广泛用于治疗癌症，包括某些类型的白血病和癌症、淋巴瘤以及肥胖和艾滋病毒。
国会对该公司的关注令制药行业感到不安，该行业已经陷入普遍的药品短缺困境，目前药品短缺程度已达到 20 年来的最高水平。一些生物技术高管进行了反击，试图让国会明白，突然的脱钩可能会导致一些药物在数年内停止研发。
药明康德及其附属公司药明生物发展迅速，为寻求削减成本并在过去几十年将大部分生产转移到海外的美国主要制药商提供服务。
药明康德公司因数千名化学家的低成本和可靠工作而享有盛誉，他们可以创造分子并操作复杂的设备来批量生产分子。据估计，药明康德参与了美国四分之一药物的开发。药明康德报告其美国业务收入约为 36 亿美元。
“它们已经成为生物技术的一站式商店，”科学家网（Scientist.com ）的创始人凯文·勒斯蒂格（Kevin Lustig）说，Scientist.com 是一家信息交换所，为寻求研究帮助的制药公司与药明康德等承包商牵线搭桥。
药明康德和药明生物还获得了数百万美元的税收优惠，用于在马萨诸塞州和特拉华州建立庞大的研究和生产基地，当地政府官员欢迎这些基地作为就业和收入来源。
自二月份以来，紧张局势不断加剧，当时四名议员要求商务部、国防部和财政部调查药明康德及其附属公司，称药明康德是“威胁美国知识产权和国家安全的巨头”。
众议院通过的一项名为《生物安全法案》的法案将该公司与中国共产党的军事部门中国人民解放军联系起来。该法案声称药明康德赞助军民活动并获得军民融合资金。
药明康德美国和欧洲首席运营官理查德·康奈尔表示，该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关联或认可” ”。 他还表示，股东无法控制公司或获取非公开信息。
上个月，在与情报人员进行机密简报后，参议院国土安全委员会以 11 比 1 的投票结果提出了一项法案：禁止美国政府与与药明康德合作的公司签订合同。政府与制药商签订的合同通常很有限，尽管这些合同为应对 COVID-19 大流行的公司带来了数十亿美元的收入。
康奈尔为该公司的记录进行了辩护，称拟议的立法“依赖于针对我们公司的误导性指控和不准确的断言”。
规模较小的生物技术公司往往依赖政府拨款且储备较少，是最令人担忧的。总部位于西雅图的 声音制药公司（Sound Pharmaceuticals ）首席执行官乔纳森·基尔 (Jonathan Kil) 博士表示，药明康德已与该公司合作 16 年，开发治疗听力损失和耳鸣或耳鸣的药物。他说，寻找另一个承包商来生产这种药物可能会让公司倒退两年。
“我不想看到的是，我们变得非常反华，以至于我们无法正确思考，”基尔说。
可能对药明康德影响最大的药物是特里卡夫塔（Trikafta），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，这是一种致命的疾病，会用令人衰弱的浓稠粘液堵塞肺部。这种治疗被认为可以净化肺部，并将大约 40,000 名美国居民的预期寿命延长数十年。它还在意大利、葡萄牙和西班牙设有制造商。
这种治疗非常有效，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，特里卡夫塔每年每位患者的费用约为 32 万美元，这对总部位于波士顿的福泰制药公司（Vertex Pharmaceuticals ）及其股东来说是一个福音，其全球收入从 2021 年的 57 亿美元增至去年的 89 亿美元。
特里卡夫塔（Trikafta）“彻底改变了囊性纤维化，而且速度非常快，”加州大学旧金山分校的肺科医生梅根·麦加里（Meghan McGarry ）博士说，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，而是不再需要住院，而是能够找到工作、上学、组建家庭。”
福泰制药（Vertex ）拒绝置评。
目前尚不清楚针对药明康德的法案今年是否会推进。参议院版本已经过修改，以保护现有合同并限制供应中断。尽管如此，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。
RA资本管理公司（RA Capital Management）管理合伙人彼得·科尔钦斯基（Peter Kolchinsky ）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合作。
他在一封电子邮件中表示：“每个人都可能在考虑从无锡和更广泛的中国撤离。”
本文最初发表于《纽约时报》。
题图：药明康德高管于 2016 年接受 STAT 采访。PAT GREENHOUSE
附原英文报道：
Chinese company under congressional scrutiny makes key US drugs
By Christina Jewett New York Times,Updated April 15, 2024
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 such as cystic fibrosis.
WuXi AppTec is one of several companies lawmakers have identified as potential threats to the security of individual Americans’ genetic information and US intellectual property. A Senate committee approved a bill in March that aides say is intended to push US companies away from doing business with them.
But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope of work WuXi does for the US 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 US medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers including some types of leukemia and lymphoma as well as obesity and HIV.
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.
WuXi AppTec and an affiliated company, WuXi Biologics, grew rapidly, offering services to major US drugmakers that were seeking to shed costs and had shifted most manufacturing overseas in the last several decades.
WuXi companies developed a reputation for low-cost and reliable work by thousands of chemists who could create 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 US work.
“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 such as WuXi.
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.
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 US intellectual property and national security.”
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.
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.
Last month, after a classified briefing with intelligence staff, the Senate Homeland Security Committee advanced a bill by a vote of 11-1: It would bar the US 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.
Connell defended the company’s record, saying the proposed legislation “relies on misleading allegations and inaccurate assertions against our company.”
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.
“What I don’t want to see is that we get very anti-Chinese to the point where we’re not thinking correctly,” Kil said.
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 US residents. It also had manufacturers in Italy, Portugal, and Spain.
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.
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.”
Vertex declined to comment.
It is unclear whether a bill targeting WuXi will advance 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.
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.
“Everyone is likely considering moving away from Wuxi and China more broadly,” he said in an email.
This article originally appeared in The New York Times.
