REBECCA ROBBINS, GINA KOLATA2026年6月1日For decades, an annual gathering of oncologists has featured drug trials that were run mainly at American and European hospitals.几十年来，一年一度的肿瘤学家盛会一直以主要在美国和欧洲医院进行的药物临床试验为主导。But at this year’s meeting, which is being held in Chicago this weekend, the signs are everywhere of China’s ascendance as a powerhouse in drug development — and of the threat that many believe it poses to American biotechnology.但在这一周于芝加哥举行的年会上，到处都释放出中国作为药物研发强国正在崛起的信号——以及许多人认为其对美国生物技术构成的威胁。The clearest sign: In what appears to be a first, one of the conference’s five coveted headliners will be a presentation of a clinical trial conducted only in China.最清晰的信号：该会议的五大重磅主旨报告之一将是一场仅在中国进行的临床试验报告的演示，这似乎是有史以来的第一次。That milestone at the meeting of the American Society of Clinical Oncology, or ASCO, reflects the dizzying growth of China’s biotechnology sector. In just a few years, it has transformed from a sleepy industry into a juggernaut rapidly inventing and testing cutting-edge medicines.美国临床肿瘤学会(ASCO)年会上的这一里程碑反映了中国生物技术领域令人眩晕的增长速度。在短短几年内，它已从一个沉寂的行业转型为一个迅速发明和测试前沿药物的巨无霸。“This tells us that the Chinese biotech industry has arrived,” said Dr. Otis Brawley, a professor at Johns Hopkins who has attended the ASCO meeting every year since 1989.自1989年以来每年都参加ASCO年会的约翰斯·霍普金斯大学教授奥蒂斯·布劳利博士说：“这告诉我们，中国的生物技术产业已经登堂入室。”But a growing contingent of U.S. officials, executives and doctors worry that the shift in drug innovation to China poses dangerous risks for research, American patients and biotech workers. They raise concerns about losing control over new medicines and about ceding America’s longstanding dominance in the field.但越来越多由美国官员、企业高管和医生组成的群体担心，药物创新向中国的转移会给科学研究、美国患者和生物技术从业者带来风险。他们担心失去对新药物的控制，以及让渡美国在该领域长期享有的主导地位。With Chinese companies churning out patents, papers in medical journals and new clinical trials, U.S. biotech start-ups say they are struggling to keep up and are facing deep disadvantages.随着中国企业不断产出专利、医学期刊论文和新临床试验，美国生物科技初创公司表示，它们难以跟上步伐，处于明显劣势。“I think the concerns are valid and very real,” said Dr. Robert Califf, a former commissioner of the Food and Drug Administration. “The U.S. is being seriously threatened.”“我认为这些担忧是合理的，也是非常真实的，”前食品和药品监督管理局局长罗伯特·卡利夫博士说。“美国正受到严重威胁。”As tensions between Washington and Beijing have escalated, Democrats and Republicans have sounded the alarm about America’s reliance on China for generic drugs and raw materials.随着华盛顿与北京之间的紧张局势升级，民主党和共和党都对美国依赖中国的仿制药和原料的问题发出了警报。Taking particular aim at China, President Trump signed legislation that barred government agencies from contracting with certain foreign biotech service providers in adversarial countries. China’s surge into cutting-edge drug development introduces a new dimension of risk, critics say.特朗普总统特别针对中国签署了法案，禁止政府机构与被列为敌对国家的特定外国生物技术服务提供商签订合同。批评人士称，中国进军前沿药物研发带来了新的风险维度。There is another worry. Will drugs work as well in American patients as they do in Chinese patients?还有一个担忧。这些药物对美国患者的疗效能否与中国患者一样好？For reasons that researchers do not fully understand, Asian patients with lung cancer tend to live longer and respond better to immunotherapies than people of other ethnicities, according to some studies.据一些研究显示，由于一些研究人员尚不完全清楚的原因，亚裔肺癌患者往往比其他族裔生存期更长，且对免疫疗法的反应更好。Yet China has a very high rate of smoking, and former smokers tend to fare worse when they get lung cancer. Further complicating the picture is differences in treatment — the cancer drugs typically used in China are often not the same as in the United States.然而，中国吸烟率非常高，而有吸烟史的肺癌患者预后往往更差。治疗差异进一步增加了复杂性——中国常用的抗癌药通常与美国并不相同。“In general, things look better in China,” said Dr. Peter Marks, who was a longtime F.D.A. official before resigning last year. “It’s a fraught area right now. I think many of us have real concerns.”“总的来说在中国看起来更好，”去年辞职的前FDA资深官员彼得·马克斯博士说。“这现在是一个充满隐患的领域。我想我们很多人都有切实的担忧。”Dr. Marks, who has since joined Eli Lilly as an executive overseeing its work on infectious diseases, stressed that he was not speaking for Lilly.马克斯现已成为礼来公司高管，负责传染病相关工作，他强调自己并非代表礼来发言。On the other side of the debate are those who warn that throttling competition from China would deprive Americans of new medicines. Ultimately, they say, the best data, no matter where it comes from, should win out.辩论的另一方则警告，扼杀来自中国的竞争将使美国人失去新药。他们说，归根结底，无论数据来自哪里，最好的数据理应胜出。In clinical trials, “patients either do well or they don’t, at the end of the day,” said Bob Duggan, a co-chief executive of Summit Therapeutics, based in Miami.在临床试验中，“归根结底，对患者要么有效，要么无效，”总部位于迈阿密的Summit Therapeutics联席首席执行官鲍勃·达根说。Summit bought the rights to the experimental drug from China, ivonescimab, that will get top billing at ASCO. The company is testing the drug in separate studies in American patients, and is seeking to bring it to market in the United States and other parts of the world. The Chinese company that invented the drug, Akeso Biopharma, already sells it in China.Summit从康方生物引进了名为依沃西单抗(ivonescimab）的实验性药物，这款药将成为ASCO年会上的头号明星。该公司正在美国患者中开展独立研究，并寻求在美国及其他地区上市。发明该药的中国公司康方生物已在中国销售该药。China’s rising influence中国影响力上升In the last few years, the world’s biggest pharmaceutical companies have been filling their pipelines by turning to China, where prices are low, regulatory hurdles are fewer, and development timelines are quick.过去几年，全球最大的制药公司纷纷转向中国充实研发管线，因为那里成本低、监管障碍少、开发周期快。So far this year, about half of such major deals involved a drug from China, up from next to nothing in the 2010s, according to DealForma, which tracks drug industry transactions.据追踪医药交易的DealForma统计，今年迄今为止，约一半的重大交易涉及中国药物，而在2010年代这一占比几乎为零。That trend will be on vivid display at ASCO. Beyond ivonescimab, other presentations feature experimental cancer drugs invented and tested in China that have been scooped up by big drugmakers like Pfizer, Merck and Bristol Myers Squibb.这一趋势将在ASCO上鲜明展现。除了依沃西单抗，其他报告还展示了由中国发明和测试、已被辉瑞、默克和百时美施贵宝等巨头收购的实验性抗癌药。In particular, the drug bought by Merck impressed the field with results, announced earlier this month, showing it slowed tumor progression in Chinese patients with advanced lung cancer.特别是默克收购的药物，本月早些时候公布的结果显示，其在延缓中国晚期肺癌患者肿瘤进展方面表现出色，令业界印象深刻。A Chinese company typically retains the rights to sell its drug in China. The big drugmakers buy the U.S. rights, spurning offerings from American start-ups that are developing similar medicines.中国公司通常保留在中国的销售权。大型制药商购买在美国销售的权益，拒绝了正在开发类似药物的美国初创公司的报价。Critics of China also point to an increasingly worrisome pattern. Chinese drug developers race to essentially copy U.S. inventions. As protection, some U.S. biotech start-ups have imposed new measures to maintain secrecy, like refusing to publish papers or present posters at conferences.对中国持批评态度者还指出了一种日益令人担忧的模式。中国药物开发者竞相“跟风”复制美国的发明。作为保护，一些美国初创公司采取了新的保密措施，如拒绝发表论文或在会议上展示海报。As Robert F. Kennedy Jr., the U.S. health secretary, put it to lawmakers at a hearing in April: “China is eating our lunch.”正如美国卫生部长小罗伯特·F·肯尼迪在4月的一次听证会上对议员们所说：“中国正在吃掉我们的午餐。”In March, Chris Klomp, one of Mr. Kennedy’s top lieutenants, described the current climate to those attending the Conservative Political Action Conference. “It’s not one of missiles and tanks,” he said. “It’s of laboratories and lifesaving medications. It’s a war right now with China on American innovation and biotechnology.”3月，肯尼迪的高级助手克里斯·克隆普在对保守派政治行动会议与会者描述当前局势时说：“这不是导弹和坦克的战争，而是实验室和救命药的战争。这是一场美中之间关于美国创新和生物技术的战争。”For now, big multinational pharmaceutical companies are developing most drugs invented in China for introduction to the U.S. market. But some fear that if more Chinese companies assume a direct role, American patients could become dangerously reliant on the Chinese government for access to vital brand-name drugs.目前，大型跨国药企正在开发大多数中国发明的药物以引入美国市场。但有人担心，如果更多中国公司直接介入，美国患者可能会对中国政府的救命专利药形成危险依赖。There is a risk, Dr. Marks said, of “creating a new Strait of Hormuz.”马克斯说，这存在“制造一个新的霍尔木兹海峡”的风险。Representative John Moolenaar, a Republican from Michigan, has called for prohibiting the F.D.A. from reviewing data from China and curbing the deal making between major U.S. drugmakers and Chinese companies. But his proposals have not gained much traction.密歇根州共和党众议员约翰·穆莱纳尔呼吁禁止FDA审评来自中国的数据，并限制美国大药企与中国公司的交易。但他的提议并未获得太多支持。Dr. Richard Pazdur, who was the F.D.A.’s longtime top cancer drug regulator and briefly led its broader drug division late last year, was well-known for refusing to approve cancer drugs based on data collected only in China.理查德·帕兹杜尔博士曾长期担任FDA首席癌症药物监管人，去年底短暂领导更广泛的药品部门。他以拒绝仅凭中国数据批准抗癌药而闻名。Now, “regulators must prepare for an environment in which some therapies with substantial patient benefit may be studied primarily, or even exclusively, in China,” Dr. Pazdur warned in an opinion piece in JAMA that he co-wrote in March.现在，“监管机构必须为一个环境做好准备：某些具有显著患者获益的疗法可能主要甚至完全在中国进行研究，”帕兹杜尔在今年3月共同撰写的一篇JAMA评论文章中警告说。Emily Hilliard, a spokeswoman for the Department of Health and Human Services, said the F.D.A. evaluates whether trials are “adequate and well-controlled, reliable and applicable to the U.S. patient population the drug is intended to address.”美国卫生与公众服务部发言人艾米丽·希利亚德表示，FDA评估临床试验是否“充分且对照良好、可靠，并适用于该药物拟治疗的美国患者人群”。ASCO’s global cloutASCO的全球影响力Seven oncologists founded ASCO in the United States in 1964, and as the field has grown globally, so has the organization.1964年，七位肿瘤学家在美国创立了ASCO，随着该领域的全球发展，该组织也随之壮大。In the world of cancer research, there are few greater honors than winning one of four or five top-billed presentation slots at the annual conference. Oncologists around the world identify and select the most important, practice-shifting science.在癌症研究领域，能在每年年会四到五个领衔报告中占据一席之地是无上的荣誉。全球肿瘤学家甄别并选出最重要、最能改变临床实践的科学成果。ASCO’s chief executive, Dr. Clifford Hudis, said this was the first time the group could recall one of those spots going to a study that enrolled patients only in China. The closest precedent was in 2021, when one headliner involved a trial of an immunotherapy drug that was conducted mostly in China, with a few sites in Taiwan and Singapore.ASCO首席执行官克利福德·胡迪斯博士表示，这是该组织记忆中首次有这样一个席位授予一项仅在中国入组患者的研究。最接近的前例是在2021年，当时一个领衔报告涉及一项免疫疗法药物试验，其研究主要在中国进行，仅有少数地点在台湾和新加坡。Dr. Hudis said that his organization was “focused on results that can improve outcomes for patients, regardless of where they live.”胡迪斯表示，他的组织“专注于能改善患者预后的结果，无论他们身在何处”。But this year’s unusual selection has been generating buzz in medical circles for weeks. Dr. Christoph Westphal, a biotech venture capital investor, called the top billing at the conference “a coming-of-age moment for China.”但这项不同寻常的选择已在医学界引发数周的热议。生物技术风险投资家克里斯托弗·韦斯特法尔博士称此次大会的领衔报告是“中国的成年礼时刻”。China’s lung cancer drug中国的肺癌药The moment of truth for the China-only study of ivonescimab comes on Sunday, when data will be presented.依沃西单抗这项仅在中国进行的研究的成色将在周日揭晓，届时将公布数据。The drug, given as an IV infusion, combines two attacks on a tumor. It unleashes the immune system with one strategy and deprives the tumor of a blood supply with another.该药通过静脉输注给药，结合了双重抗肿瘤机制：一方面激活免疫系统，另一方面切断肿瘤的血液供应。The study, involving more than 500 patients newly diagnosed with advanced lung cancer, looked at survival rates in a group that received the drug and in a group treated with a different immunotherapy. (Both groups also underwent chemotherapy.)这项研究涉及超过500名新诊断的晚期肺癌患者，比较了接受该药组和接受另一种免疫疗法组的生存率。（两组均接受了化疗。）The drug used in the comparison group, Tevimbra, is not approved for lung cancer in the United States, where patients typically get the blockbuster immunotherapy Keytruda along with chemotherapy.对照组使用的药物替雷利珠单抗(Tevimbra)目前未获FDA批准用于肺癌，美国患者通常用重磅免疫药可瑞达(Keytruda)配合化疗。Because the Chinese trial did not examine whether its drug extended lives longer than Keytruda did, U.S. oncologists will have to try to parse what the results mean for U.S. patients, said Dr. Roy Herbst, the incoming director of the Dartmouth Cancer Center.达特茅斯癌症中心候任主任罗伊·赫布斯特博士说，由于这项中国试验并未直接比较该药是否比可瑞达更能延长生命，美国肿瘤学家将不得不费力解读这些结果对美国患者意味着什么。Akeso, which funded the study, declined an interview request.资助该研究的康方生物拒绝了采访请求。Summit has applied for F.D.A. approval of ivonescimab based on the results of a global study in the United States, Canada and Europe. The F.D.A. said it would decide by November whether to approve the drug.Summit已基于在美国、加拿大和欧洲进行的全球研究结果向FDA提交了依沃西单抗的上市申请。FDA表示将在11月前决定是否批准该药。In April, Summit disclosed early results from another key global study with American patients that sharpened questions about how well ivonescimab will work outside of China. The company said the drug failed to meet a statistical bar that, if successful, might have expedited regulatory approval.4月，Summit披露了另一项针对美国患者的关键全球研究的早期结果，加剧了人们对依沃西单抗在中国境外疗效的质疑。该公司表示，该药未能达到统计学阈值，若成功本可加速审批。The disappointing results sunk Summit’s stock. Now, the company will wait for the study’s final data, expected later this year.这一令人失望的结果导致Summit股价暴跌。目前，公司将等待预计于今年晚些时候公布的该研究最终数据。Rebecca Robbins是《纽约时报》记者，报道制药业。她自2015年以来一直从事健康和医学方面的报道。Gina Kolata报道报道疾病和治疗方法、治疗方法的发现和测试方式以及它们如何影响人们。翻译：纽约时报中文网点击查看本文英文版。获取更多RSS：https://feedx.net https://feedx.site