Recently The New York Times reported the following:
China’s Rise in Drug Development Looms Over U.S. (1/2)
Clinical trials in China are getting attention at an
international oncology gathering in Chicago. China’s surging biotechnology
industry is fueling alarm that U.S. dominance in the field is waning.
The NYT - By Rebecca Robbins and Gina Kolata
May 30, 2026
Updated 11:21 a.m. ET
For decades, an annual gathering of oncologists has featured
drug trials that were run mainly at American and European hospitals.
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.
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.
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.
“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.
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.
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.
“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.”
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.
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.
There is another worry. Will drugs work as well in American patients as they do in Chinese patients?
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.
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.
“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.”
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.
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.
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.
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.
(to be continued)
Translation
中國藥物研發崛起令美國感到壓力(1/2)
在芝加哥舉行的國際腫瘤學大會上,中國的臨床試驗備受關注。中國蓬勃發展的生物技術產業引發了人們的擔憂,即美國在該領域的主導地位正在減弱
幾十年來,一年一度的腫瘤學家大會一直的特色是以在美國和歐洲醫院進行的藥物試驗為主。
但在今年於芝加哥舉行的會議上,處處都反映著中國作為藥物研發強國的崛起 - 以及許多人認為它是對美國生物技術的威脅。
最明顯的跡像是:本次大會五大重頭戲之一,將首次展示一項完全在中國進行的臨床試驗。
中國在美國臨床腫瘤學會(ASCO)年會上取得的這一里程碑式成就,反映了它的生物技術產業的驚人成長。短短幾年內,中國生技產業就從一個沉寂的產業蛻變為一個快速研發和測試尖端藥物的巨頭。
自1989年以來每年都參加ASCO年會的約翰霍普金斯大學教授Otis Brawley博士說道:「這顯示中國生物技術產業已經崛起」。
然而,越來越多的美國官員、企業高層和醫生擔心,藥物創新向中國的轉移會對研究、美國患者和生物技術從業人員帶來危險的風險。他們擔憂會失去對新藥的控制權,並放讓出美國在該領域長期以來的主導地位。
隨著中國企業不斷申請專利、在醫學期刊上發表論文並進行新的臨床試驗,美國生技新創公司表示,他們難以跟上步伐,面臨嚴重的不利局面。
美國食品藥物管理局前局長Robert Califf博士說:“我認為這些擔憂是合理且非常現實的”,“美國正面臨嚴重的威脅。”
隨著華盛頓和北京之間的緊張局勢升級,民主黨和共和黨都對美國依賴中國提供仿製藥和原料發出警告。
特朗普總統尤其針對中國,簽署了一項法案,禁止政府機構與敵對國家的某些外國生物技術服務提供者去簽訂合約。批評人士稱,中國在尖端藥物研發領域的崛起帶來了風險的新層面。
還有另一個令人擔憂的問題:藥物對美國患者的療效是否與對中國患者有一樣好的療效?
一些研究表明,因一些研究人員尚未完全了解的原因,亞裔肺癌患者的存活期往往比其他種族患者更長,對免疫療法的反應也更好。
然而,中國的吸煙率非常高,而曾經吸煙的人罹患肺癌之後的情况往往更差。治療方案的差異進一步加劇了問題的複雜性 - 中國通用的抗癌藥物常常與美國通用的藥物不同。
曾長期擔任美國食品藥物管理局(FDA),並已去年辭職的Peter Marks博士說: 「總的來說,中國的情況看起來更好」; 「目前這是一個充滿爭議的領域。我認為我們有很多人都對此深感擔憂」。
Marks博士目前已加入Eli Lilly公司,擔任傳染病業務主管。他強調,他的發言並不代表Eli Lilly公司的立場。
另一方面,也有人警告說,限制來自中國的競爭將使美國人無法獲得新藥。他們認為,最終,無論數據來自何處,都應該以最佳數據為準。
總部位於邁阿密的Summit Therapeutics公司聯合首席執行官Bob Duggan表示,在臨床試驗中,“最終結果要么是患者療效顯著,要么是療效不佳。”
Summit公司從中國購得了實驗性藥物ivonescimab的專利權,該藥物將在ASCO年會上成為焦點。該公司正在美國患者中進行該藥物的獨立研究,並尋求將其推向美國及世界其他市場。該藥物的中國研發公司 - Akeso Biopharma已在中國銷售該藥物。
(待續)