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| An advisory committee to the Food and Drug Administration overwhelmingly voted on Thursday against recommending agency approval of a lung cancer drug that was tested only in China and sold there. | 周四，美国食品与药品管理局（简称FDA）的一个顾问委员会以压倒性多数投票拒绝建议FDA批准一种肺癌药物，该药物仅在中国进行过试验和销售。 |
| The drug, sintilimab, is a checkpoint inhibitor — a type of immunotherapy drug that unleashes the immune system to attack tumors. It was developed and tested in China by Innovent Biologics, which entered into an agreement with Eli Lilly that would have allowed Lilly to market it in the United States, if it were approved. It was to be used in combination with chemotherapy for patients with metastatic non-small-cell lung cancer. | 该药物名为信迪利单抗(sintilimab)，是检查点抑制剂——一种通过激发免疫系统来攻击肿瘤的免疫疗法。该药由信达生物在中国研发和试验，并与礼来制药公司达成协议，如获批准，将由礼来负责在美国的销售。该药物将和化疗一起被用于转移性非小细胞肺癌患者的治疗。 |
| The F.D.A. panel debated a longstanding issue: What standards should be used in approving drugs? Should a drug tested only in China or another country outside the United States be accepted without domestic trials? | FDA专家组争论的一个长期存在的疑问在于：批准药物时应采用何种标准？是否应该接受缺乏美国国内试验、仅在中国或美国以外的其他国家试验过的药物？ |
| The decision is likely to be closely monitored for clues about whether it further exacerbates tensions between the United States and China, especially given the strains between the two countries over research by Chinese scientists in recent years. Immunotherapy drugs are so expensive in the United States that the potential to bring a cheaper therapy to the market also weighed heavily in the background of the discussion on Thursday. | 尤其考虑到美中近年来在中国科学家的研究成果上的矛盾，这一决定可能会受到密切关注，因其可能暗示两国的紧张关系会否进一步加剧。免疫疗法在美国非常昂贵，因此，将一种更廉价的疗法推向市场的可能性也成为了周四讨论的重要背景。 |
| Dr. Richard Pazdur, the powerful director of the F.D.A.’s oncology unit, explained on Thursday why he had backtracked from a far more welcoming attitude in 2019, when he said the agency might consider a checkpoint inhibitor tested solely in China. | 周四，FDA肿瘤学部门的权威主任专家理查德·帕兹杜尔解释了他为何一改自己在2019年更欢迎此类药物的立场，当时他曾表示，FDA可能会考虑批准仅在中国试验的检查点抑制剂。 |
| “Over the past two or three years, this country has experienced tremendous social change,” he said at the meeting. “We clearly heard from all patient groups that they want faces like theirs.” That, he said, is also important to build confidence in the clinical trials and the drugs being tested. | “在过去的两三年里，这个国家经历了巨大的社会变革，”他在会上表示。“我们明确听到了各类患者群体的声音，那就是想要看到和自己一样的面孔。”他说，这对建立公众对临床试验和被试验药物的信心也很重要。 |
| A drug tested only in China is “a step backward,” he said. | 他说，仅在中国进行试验的药物是“一种倒退”。 |
| The agency has faced considerable pressure to include diverse patient groups, reflecting various ethnic and racial populations, in clinical trials in the United States as well as to address health disparities. | 在美国临床试验中纳入能反映不同族裔和种族的多样化患者群体和解决健康状况差异的问题上，该机构面临着相当大的压力。 |
| Lilly released a statement saying that it was disappointed and that it had “hoped that sintilimab could have played a positive role for patients and the U.S. health care system through an aggressive pricing strategy.” | 礼来发布声明表达了失望，并称公司原本“希望信迪利单抗能依靠有竞争力的定价策略，为患者和美国医疗系统带来积极影响”。 |
| But, the company said that “we acknowledge that the landscape has changed dramatically” and that Lilly “wholeheartedly agrees with the importance of ethics in clinical trial conduct and clinical trial diversity.” | 但该公司表示，“我们承认，形势已经发生了巨大变化，”而礼来“完全认同伦理在临床试验过程和临床试验多样性中的重要性。” |
| The company said it “will be working with FDA on next steps.” | 该公司称“将会配合FDA开展下一步工作”。 |
| Another issue surrounded Lilly’s decision to even submit this drug for U.S. approval. An analysis by the F.D.A.’s staff of the trial results in China was scathing on methodological grounds. It cited a failure to provide patients in the control group with an approved therapy that is standard of care; questioned the competence of some of the investigators who had no previous experience with such trials; noted a patient population that was younger, had more men, and had fewer smokers than U.S. lung cancer patients; and criticized use of an endpoint that is considered not always reliable. | 礼来将该药物提交美方审批的决定也引发了争议。FDA对该药物在中国试验结果的分析报告对于方法的要求非常严苛。报告指出，试验未能向对照组患者提供获得批准的标准疗法；对一些此前没有此类试验经验的调查员的能力表示了怀疑；提到了受试患者群体比美国肺癌患者群体更年轻、男性更多、吸烟者更少；还对一个并不总是可靠的临床试验终点的使用提出了批评。 |
| Lilly had promoted its application by saying that it wanted to use sintilimab as a wedge to break the stratospheric prices of cancer immunotherapy. | 礼来在推广该药物的应用时曾表示，希望信迪利单抗能成为打破癌症免疫治疗天价的利器。 |
| Already on the market are several other checkpoint inhibitors, which make cancers vulnerable by blocking a protein that tumors use as sort of an invisible shield to protect them from an immune system attack. These immunotherapy drugs treat such cancers as colon, breast, liver and lung, and carry list prices that are nearly identical — about $150,000 a year per patient. | 市面上已经有了另外几种检查点抑制剂，这些药物通过阻断蛋白来攻克癌症，肿瘤会利用这种蛋白形成防护，以免受免疫系统的攻击。这类免疫治疗药物可被用于结肠癌、乳腺癌、肝癌和肺癌等癌症，价格几乎一样——每位患者每年平均要花费大约15万美元。 |
| Lilly said it would charge 40 percent less if its drug were approved. Sintilimab costs $6,000 a year in China. | 礼来表示，如果该公司研发的药物获得批准，价格将降低40%。在中国使用信迪利单抗一年的费用为6000美元（约合3.8万人民币）。 |
| The company’s idea of breaking the price lock on such drugs is “a big deal,” Brad Loncar, a biotechnology industry investor, said. | 生物科技行业投资人布拉德·隆卡尔表示，礼来想要打破此类药物价格锁定是“非同小可”的想法。 |
| “I’m not aware of any precedent of a company, especially of Lilly’s size and credibility, announcing that a discounted price like this is how they planned to innovate,” Mr. Loncar said. | “据我所知，没有任何一家公司，尤其是像礼来这种规模和信誉的公司，会宣称这样的折扣价就是他们计划的创新方式，”隆卡尔说道。 |
| Now, he added, the near certainty that the drug application would be rejected “means that a real option for substantially lower drug prices is being closed in the U.S.” (The F.D.A. generally follows the recommendations of its advisory committees.) | 他还表示，现在，该药物的审批基本不会通过“意味着美国拒绝了大幅降低药价的实际选择”。（FDA通常会遵循其顾问委员会的建议。） |
| Others were not persuaded by Lilly’s claim to be a market disrupter. | 其他人则没有被礼来声称自己是市场颠覆者的主张说服。 |
| Dr. Scott Ramsey, a health economist and cancer specialist at Fred Hutchinson Cancer Center in Seattle, was among those who were skeptical of Lilly’s motives. “Yeah, right,” he commented. | 西雅图福瑞德·哈金森癌症中心的健康经济学家和癌症专家斯科特·拉姆齐就是对礼来的动机持怀疑态度的人之一。“得了吧，”他评价道。 |
| “Are they talking about the stranglehold on prices that their current drugs contribute to?” Dr. Ramsey asked. “Maybe they could start by knocking 40 percent off their price” for Cyramza — a stomach cancer drug with a list price of $13,400.32 to $15,075.36 per month — and Verzenio, a breast cancer drug with a similar price. | “他们是在谈论他们目前的药物对价格造成的束缚吗？”拉姆齐问道。“也许他们可以考虑给这些药品降价40%”——标价为每月13400.32美元至15075.36美元的胃癌药物欣锐择(Cyramza)和同价位的乳腺癌药物唯择(Verzenio)。 |
| “I don’t buy it,” Dr. Ramsey said of Lilly’s price disrupter story, and instead chalked it up to a public relations stunt. | 拉姆齐谈到礼来的价格颠覆时说：“我不相信这种说法。”他将其归结为公关噱头。 |
| It is well known that the F.D.A. is not permitted to consider price in evaluating whether a drug should be approved. That means that any F.D.A. decision must be based solely on whether the drug meets its standards. | 众所周知，FDA在评估药物是否应获批时是不允许考虑价格的。这意味着任何FDA决定必须完全基于药物是否符合其标准。 |
| For that reason, Dr. Aaron Kesselheim, a professor of medicine at the Harvard T.H. Chan School of Public Health and an expert on the pharmaceutical industry, was puzzled. | 出于这个原因，哈佛大学陈曾熙公共卫生学院医学教授、医药行业专家亚伦·凯塞尔海姆感到困惑。 |
| “I’m not aware of a company ever before announcing its pricing strategy just before an AdComm meeting, particularly one in which the general perception is that the F.D.A. was going to argue that the data don’t seem to support approval,” he said, referring to the agency’s advisory committee panel. “It does seem like a strategic ploy intended to inject a consideration into the AdComm deliberations that is not supposed to be considered.” | 他说：“我没听说过任何公司会在AdComm会议之前宣布其定价策略，尤其是当普遍认为FDA会说数据似乎不支持批准。“AdComm指的是该机构的咨询委员会小组。“这似乎是一种策略，旨在为AdComm的审议注入不应该考虑的考虑因素。” |
| The story of sintilimab dates to 2019 at the annual meeting of the American Association of Cancer Research. Speaking there, Dr. Pazdur said the agency would be open to considering drugs tested solely in other countries. | 信替利单抗的故事可以追溯到2019年美国癌症研究协会年会。帕兹杜尔在那里发表讲话说，该机构愿意考虑仅在其他国家试验过的药物。 |
| Lilly, which had said it had not planned to market sintilimab outside China, said at the meeting that it then decided to see if the drug could be approved in the United States. The company met with the agency three times in 2020 and proceeded to apply for marketing approval. | 礼来曾表示不打算在中国以外销售信替利单抗，该公司在会议上表示，它后来决定试试该药能否在美国获得批准。2020年，礼来与该机构三次会面，并着手申请销售许可。 |
| In the intervening years, however, Dr. Pazdur expressed increasing concern about what seemed to be a rush by companies large and small to bring checkpoint inhibitors to the market. | 然而，在随后的几年里，帕兹杜尔表达了越来越多的担忧，即大大小小的公司似乎都急于将检查点阻断剂推向市场。 |
| In December, in The New England Journal of Medicine, Dr. Pazdur noted that more than 2,000 clinical trials testing checkpoint inhibitors were underway, with many trials taking place in China. | 12月，在《新英格兰医学杂志》上，帕兹杜尔博士指出，超过2000个检查点阻断剂的临床试验正在进行中，其中许多试验在中国进行。 |
| Dr. Pazdur added that “the unbridled and rapid growth of checkpoint inhibitors has led to a Wild West of drug development, featuring a stampede of commercial sponsors, clinical trials and redundant development plans.” | 帕兹杜尔补充说：“检查点阻断剂的肆无忌惮的快速增长导致了药物开发的狂欢，这里有大量商业赞助商、临床试验和过剩的开发计划。” |
| “Every major company and even small companies has a checkpoint inhibitor,” said Donald Berry, a statistics professor and cancer clinical trial expert at the M.D. Anderson Cancer Center in Houston. “It’s amazing how easy it is to make these things,” he added. | “每家大公司甚至小公司都有检查点阻断剂，”休斯顿M·D·安德森癌症中心的统计学教授和癌症临床试验专家唐纳德·贝瑞说。他还说：“令人惊讶的是，做这些东西是多么容易。” |
| In an article published on Feb. 4 in Lancet Oncology, Dr. Pazdur wrote that there were “at least 25 applications from China in drug development phases, planned to be submitted or currently under review.” | 帕兹杜尔在2月4日发表在《柳叶刀肿瘤学》杂志上的一篇文章中写道，“至少有25份来自中国的申请处于药物开发、计划提交或正在审批阶段。” |
| The agency has long had strict rules about approving drugs that were tested solely overseas, requiring that the data be applicable to patients and medical practice in the United States, that the investigators had “recognized competence” and that the agency be able to validate the data. | 该机构长期以来对批准仅在海外试验的药物有严格的规定，要求数据适用于美国的患者和医疗实践，研究人员具有“公认的能力”，并且该机构能够验证数据。 |
| In a withering critique of Lilly’s submission on this new trial from China, F.D.A. staff members assigned to conduct an analysis said that on every count the sintilimab application fell short. One issue was how to evaluate the drug. The study asked how long it took before the cancer started growing again or before the patient died. That endpoint, known as progression free survival, Dr. Pazdur said at the meeting, is out of date for such studies. Instead, the appropriate endpoint, he suggested, is what matters to patients most — how long will they live. | FDA指派进行分析的工作人员严厉批评了礼来提交的这项来自中国的新试验，说信迪利单抗的应用在每个方面都达不到要求。其中一个问题是如何评估这种药物。该研究探索了多久后癌症会复发或患者死亡，即无进展生存期。帕兹杜尔在会议上说，这样的治疗目标对于此类研究来说已经过时了。相反，他建议，适当的目标是他们能活多久，这是对患者最重要的。 |
| “There’s a famous story of Avastin in metastatic breast cancer,” Dr. Berry said. “It showed enormous benefit for progression-free survival, but with additional follow-up it was not beneficial for overall survival.” | “有一个关于阿瓦斯汀(Avastin)治疗转移性乳腺癌的著名故事，”贝瑞说。“治疗显示出对无进展生存期的巨大益处，但进一步的研究显示它对总生存期无益。” |
| A few years ago, progression-free survival might have been more acceptable but, Dr. Pazdur said, it no longer is and it’s another example of how “the landscape has changed.”To get Lilly’s drug approved, the panel voted to recommend requiring another trial that would be applicable to U.S. patients. | 几年前，无进展生存期可能更容易被接受，但帕兹杜尔说，现在已经不再是这样了，这是“情况发生了变化”的另一个例子。为了让礼来的药物获得批准，专家组投票建议要求另一项适用于美国患者的试验。 |
| But Dr. Jorge Nieva, associate professor of medicine at the University of Southern California, who was the only dissenting panel member, said there was no evidence that the data was unreliable and that it was not the panel’s job to determine how many drugs on the market would be too many. | 但南加州大学医学副教授豪尔赫·涅瓦是唯一持不同意见的专家组成员，他说没有证据表明数据不可靠，而且判断市场上的药物是否太多也不是专家组的工作。 |
| “Having more drugs competing for those same patients will have, I think, greater impact on equity than the need for diversity in clinical trial enrollment, which I believe is important,” Dr. Nieva said. | “我认为，让更多的药物竞争同样的患者，这对公平性的影响比高于其对临床试验注册所需的多样性的影响，我认为这很重要，”涅瓦说。 |
| But Dr. Pazdur’s views carried the day, alluding to more policy changes, perhaps. | 但帕兹杜尔的观点占据了主导地位，或许暗示了更多的政策变化。 |
| “There is a change in our perception of what we want from international trials,” he said. China has, so far, rarely participated. | 他说：“对于从国际试验中想要获得什么，我们的看法发生了变化。”迄今为止，中国很少参与这样的试验。 |
| “We want to bring China in,” Dr. Pazdur said. “We feel we would all benefit.” | “我们想让中国参与进来，”帕兹杜尔说。“我们觉得我们都会受益。” |
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