中國藥物研發崛起令美國感到壓力（2/2）

Recently The New York Times reported the following:

China’s Rise in Drug Development Looms Over U.S. (2/2)

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

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China’s rising influence

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.

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.

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.

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.

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.

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.

As Robert F. Kennedy Jr., the U.S. health secretary, put it to lawmakers at a hearing in April: “China is eating our lunch.”

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.”

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.

There is a risk, Dr. Marks said, of “creating a new Strait of Hormuz.”

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.

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.

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.

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.”

ASCO’s global clout

Seven oncologists founded ASCO in the United States in 1964, and as the field has grown globally, so has the organization.

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.

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.

Dr. Hudis said that his organization was “focused on results that can improve outcomes for patients, regardless of where they live.”

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.”

China’s lung cancer drug

The moment of truth for the China-only study of ivonescimab comes on Sunday, when data will be presented.

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.

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.)

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.

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.

Akeso, which funded the study, declined an interview request.

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.

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.

The disappointing results sunk Summit’s stock. Now, the company will wait for the study’s final data, expected later this year.

Translation

中國藥物研發崛起令美國感到壓力（2/2）

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

（繼續）

中國日益增長的影響力

近年來，全球最大的製藥公司紛紛轉向中國以充實其產品線。在中國，藥物價格低廉、監管關卡較少、研發週期短。

根據追蹤製藥業交易的DealForma統計，今年迄今，全球此類重大交易中約有一半涉及來自中國的藥物，而2010年代這一比例幾乎是零。

這一趨勢將在ASCO會議上充分展現。除了ivonescimab之外，其他報告還介紹了在中國研發和測試的實驗性抗癌藥物，這些藥物已被輝瑞、默克、及百時美施貴寶 (Bristol Myers Squibb) 等大型製藥公司收購。

尤其值得一提的是，默克收購的藥物在本月初公佈的試驗結果令業界矚目，結果顯示，藥物能夠延緩中國晚期肺癌患者的腫瘤演變。

中國公司通常保留其藥物在中國的銷售權。而大型製藥公司則購買美國市場的權利，拒絕美國新創公司所開發提供的類似藥物。

批評人士也指出，中國製藥企業競相複製美國發明，這種現象令人擔憂。為了保護自身利益，一些美國生技新創公司採取了新的保密措施，例如拒絕發表論文或在會議上展示海報。

正如美國衛生部長Robert F. Kennedy Jr. 在四月份的一次聽證會上對議員們所說： “中國正在搶走我們的飯碗。”

今年三月，Kennedy的得力助手之一Chris Klomp在保守派政治行動會議上向與會者描述了當前的情況。 他說:“「這不是關於飛彈和坦克的事情」;「這是關於實驗室和拯救生命的藥物。這是一場美國與中國之間在創新和生物技術方面的戰爭。」

目前，大多數在中國研發的藥物正在被大型跨國製藥公司開發並引進美國市場。但有人擔心，如果有更多中國公司直接參與其中，美國患者可能會危險地過度依賴中國政府才能獲得重要的品牌藥。

Marks博士說，這存在著「製造新的霍爾木茲海峽」的風險。

來自密西根州的共和黨眾議員John Moolenaar呼籲禁止美國食品藥物管理局（FDA）檢查和分析來自中國的數據，並限制美國大型製藥公司與中國公司之間的交易。但他的提議並未獲得太多支持。

Richard Pazdur博士曾長期擔任美國食品藥物管理局（FDA）癌症藥物監管部門負責人，並於去年底短暫領導該局範疇更大的藥物部門。他以拒絕僅基於中國收集的數據批准癌症藥物而聞名。

Pazdur博士在3月份與他人合著發表於《美國醫學會雜誌》（JAMA）的一篇評論文章中警告說：如今， “監管機構必須做好準備，應對這樣一種環境：一些對患者有顯著益處的療法可能主要甚至完全在中國進行研究。”

美國衛生與公眾服務部發言人Emily Hilliard表示，FDA會評估試驗是否「充分且良好地控制、可靠，並且該藥物的預計療効是適用於美國患者群體」。

ASCO的全球影響力

1964年，七位腫瘤學家在美國創立了ASCO。隨著腫瘤學領域的全球發展，該組織也隨之壯大。

在癌症研究領域，能贏得年度大會上四、五個重點報告位之其中一，無疑是莫大的榮譽。來自世界各地的腫瘤科醫師會從中遴選出最重要、最具實踐轉變意義的科學成就。

美國臨床腫瘤學會（ASCO）執行長Clifford Hudis博士表示，據該學會回憶，這是他們首次將重點報告位授予一項僅在中國招募患者的研究。先前最接近的先例是在2021年，當時的一項重點報告涉及一種免疫療法藥物的試驗，該試驗主要在中國進行，並在台灣和新加坡設有少量研究地點。

Hudis博士表示，他的機構「專注於能夠可以改善患者的治療效果，無論他們身在何處」。

但今年這項不同尋常的選擇已在醫學界引發數週熱議。生物技術創投家Christoph Westphal博士稱，此次大會的重點報告位是「標誌着中國走向成熟」。

中國的肺癌藥

僅在中國進行的 ivonescimab 研究的真相時刻將於週日來臨，屆時數據將會公佈出來。

該藥物透過靜脈輸注給藥，結合兩種策略攻擊腫瘤：一種策略激活免疫系統，另一種策略阻斷腫瘤的血液供應。

這項研究涉及500多名新確診的晚期肺癌患者，比較了接受該藥物治療組，和接受另一種免疫療法治療組的存活率。 （兩組患者也都接受了化療。）

對照組使用的藥物Tevimbra尚未允許在美國用於治療肺癌，在美國，肺癌患者通常會接受重磅免疫療法Keytruda加上化療。

達特茅斯癌症中心即將上任的主任Roy Herbst博士表示，由於這項中國試驗並未考察該藥物是否比Keytruda更能延長患者生存期，美國腫瘤學家將不得不努力解讀這些結果對美國患者的意義。

資助這項研究的Akeso公司拒絕了採訪要求。

Summit公司已根據一項在美國、加拿大和歐洲進行的全球研究結果，向美國食品藥物管理局（FDA）申請核准 ivonescimab。 FDA表示將在11月前決定是否批准該藥物。

今年4月，Summit公司公佈了另一項針對美國患者的關鍵全球研究的早期結果，這加深了人們對ivonescimab在中國以外地區療效的質疑。該公司表示，該藥物未能達到統計學標準，如果達到該標準，可能會加快監管部門的審批流程。

令人失望的結果導致Summit公司的股價下跌。目前，該公司將等待該研究的最終數據，預計今年稍後公佈。

So, many big multinational pharmaceutical companies are developing most drugs invented in China for introduction to the U.S. market. This development has caused fear in the US 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. Many world’s biggest pharmaceutical companies are filling their stocks by turning to China, where prices are low, regulatory hurdles are fewer, and development timelines are quick. Critics of China also point out that Chinese drug developers race to essentially copy U.S. inventions and that there is a war right now with China on American innovation and biotechnology. Apparently, the US politicians will deal with this challenge from China.