China Biotech’s Stunning Advance Is Changing the World’s Drug Pipeline
中国生物技术的惊人进步正在改变世界药物研发线

The biotechnology industry is experiencing a tectonic shift, driven by Chinese drugmakers who have come a long way from their copycat days to challenge Western dominance on innovation.
生物技术行业正在经历一场结构性转变，推动这一转变的中国制药商已经从模仿时代走出来，挑战西方在创新领域的主导地位。

The number of novel drugs in China — for cancer, weight-loss and more — entering into development ballooned to over 1,250 last year, far surpassing the European Union and nearly catching up to the US’s count of about 1,440, an exclusive Bloomberg News analysis showed.
彭博新闻独家分析显示，去年中国进入研发阶段的抗癌、减肥等新药数量激增至 1,250 多种，远远超过欧盟，几乎赶上美国的约 1,440 种。

And the drug candidates from the land once notorious for cheap knock-offs and quality issues are increasingly clearing high bars to win recognition from both drug regulators and Western pharmaceutical giants.
而来自曾经因廉价仿冒品和质量问题而臭名昭著的中国的候选药物正日益突破高门槛，赢得药品监管机构和西方制药巨头的认可。

The findings, gleaned from an analysis of a database maintained by pharma intelligence solutions provider Norstella, show a fundamental shift in medical innovation’s center of gravity. With President Donald Trump already threatening tariffs on the pharmaceutical sector, China's biotech advances — the scale of which is slowly coming into view — risk becoming another realm of superpower rivalry like artificial intelligence and electric vehicles.
这项研究结果来自对制药情报解决方案提供商 Norstella 维护的数据库的分析，表明医疗创新的重心正在发生根本性转变。鉴于唐纳德·特朗普总统已威胁对制药行业征收关税 ，中国生物技术的进步——其规模正逐渐显现——有可能成为与人工智能和电动汽车类似的超级大国竞争的另一个领域。

“The scale itself is not something we’ve seen before,” said Helen Chen, managing partner at LEK Consulting in Shanghai, who has advised healthcare companies on their China strategy since 2003. “The products are here, they’re attractive and they’re fast.”
“这种规模是我们以前从未见过的，”艾意凯咨询驻上海的管理合伙人陈海伦表示，她自 2003 年以来一直为医疗保健公司的中国战略提供咨询服务。“我们的产品已经上市，它们很有吸引力，而且发展速度很快。”

This shift has occurred at an unprecedented pace. When China began to overhaul its drug regulatory system in 2015, the country had just 160 compounds to contribute to the global pipeline of innovative drugs, or less than 6% of the total, behind Japan and the UK. The reforms helped streamline reviews, enforced data quality standards and improved transparency. The government’s ‘Made in China 2025’ plan to elevate manufacturing in 10 priority sectors also helped spur a flurry of investments in biotechnology. Altogether, they unleashed a boom led by foreign-educated and -trained scientists and entrepreneurs.
这种转变以前所未有的速度发生。2015年，中国开始全面改革药品监管体系时，全球创新药物研发管线中仅有160种化合物，占总量的不到6%，落后于日本和英国。这些改革有助于简化审查流程，强化数据质量标准，并提高透明度。政府提出的“中国制造2025”计划旨在提升十大重点领域的制造业，这也刺激了生物技术领域的投资热潮。总而言之，这些改革引发了由海外教育和培训的科学家和企业家引领的生物技术产业繁荣。

Read More: Big Pharma Gets Boost as China Speeds Up New Drug Approvals
阅读更多： 中国加快新药审批，大型制药公司受益

“Not only is it now almost at parity with the US but it has that growth trajectory,” said Daniel Chancellor, vice president of thought leadership at Norstella. “It wouldn’t be sensationalist to suggest that China will overtake the US in the next few years purely in terms of numbers of drugs that it’s bringing through into its pipeline.”
Norstella 思想领导力副总裁丹尼尔·钱塞勒表示：“中国不仅现在几乎与美国持平，而且还保持着这样的增长轨迹。如果仅从新药上市数量来看，就断言中国将在未来几年超越美国，这并不耸人听闻。”

Bloomberg News' data analysis focuses on innovative drugs, excluding generic combinations, reformulations and biosimilars.
彭博新闻的数据分析侧重于创新药物，不包括仿制药组合、配方药物和生物仿制药。

Numbers aside, the more stunning leap is in the quality of Chinese biotech innovation. While there's constant debate in the pharmaceutical industry on whether Chinese firms are capable of producing not just effective but needle-shifting new therapies, there's growing recognition on multiple fronts. The world’s strictest regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, increasingly view Chinese drugs as generally promising enough to justify devoting extra resources to speed up their review, handing them coveted industry designations such as priority review, breakthrough therapy designation or fast track status.
除了数字之外，更令人瞩目的是中国生物技术创新质量的飞跃。尽管制药行业一直在争论中国企业是否有能力生产出不仅有效而且具有颠覆性意义的新疗法，但各方在多个方面对此的认可度正在不断提高。包括美国食品药品监督管理局和欧洲药品管理局在内的全球最严格的监管机构越来越多地认为，中国药品总体上前景广阔，值得投入额外资源来加快其审查速度，并授予其令人垂涎的行业称号，例如优先审查、突破性疗法认定或快速通道资格。

The country is now slightly ahead of the EU in earning such expedited reviews as of 2024, the data shows, a remarkable edge over a region that previously produced drugs like Wegovy.
数据显示，截至 2024 年，该国在获得此类快速审查方面略微领先于欧盟，与之前生产 Wegovy 等药物的地区相比，具有显著优势。

One of the early exemplars of Chinese innovation is a cell therapy that has shown promise to potentially cure a deadly blood cancer. First developed in China by Legend Biotech Corp, it is now marketed by Johnson & Johnson — having won a few expedited review designations along the way — and considered superior to a competing US-originated therapy.
中国创新的早期典范之一是一种细胞疗法，它显示出有望治愈一种致命血癌的潜力。该疗法最初由中国传奇生物科技公司开发，目前由强生公司上市——在此过程中获得了几次快速审查资格——并被认为优于一种源自美国的竞争疗法。

Still, the absolute number of China-originated drugs winning these designations trail their US counterparts by a large margin.
尽管如此，获得这些称号的中国原产药品的绝对数量仍远远落后于美国药品。

Risk-aversion remains a factor holding back Chinese pharmaceutical innovation: So far, top companies tend to focus on making better versions of existing therapies or new iterations of older ideas, and few are pioneering novel treatment approaches that have never been tried before — an endeavor that comes with a high risk of failure and is still led by the US, Europe and, to a lesser extent, Japan.
规避风险仍然是阻碍中国医药创新的一个因素：到目前为止，顶尖公司往往专注于改进现有疗法或对旧理念进行新的迭代，很少有公司开拓从未尝试过的新型治疗方法——这种尝试具有很高的失败风险，并且仍然由美国、欧洲以及程度较轻的日本引领。

Nevertheless, the biggest Chinese breakthroughs are increasingly being snapped up by pharmaceutical giants for record sums, a sign that the perennial competition for the next blockbuster drug is also shifting East.
尽管如此，中国最大的突破正日益被制药巨头以创纪录的价格抢购，这表明对下一个重磅药物的长期竞争也正在向东方转移。

A novel cancer drug from Akeso Inc., which came out more effective than Merck & Co Inc.’s Keytruda in a Chinese study last year, has been likened to China biotech’s DeepSeek moment, spawning a new wave of global interest. The promise of topping Keytruda, the world’s top-selling drug, also swelled the valuation of Summit Therapeutics Inc, which in 2022 paid $500 million upfront for the development and marketing rights in the US and other regions.
康方生物的新型抗癌药物，其疗效优于默克公司的 Keytruda去年在中国的一项研究中，该药物被比作中国生物科技领域的“深寻时刻”，引发了全球新一轮的关注 。超越全球最畅销药物 Keytruda 的前景也推高了 Summit Therapeutics Inc.的估值。该公司于 2022 年预付了 5 亿美元，获得了在美国和其他地区的开发和营销权。

Read More: Big Pharma’s Bet on China Biotech Is a Rare Trade Bright Spot
阅读更多： 大型制药公司押注中国生物科技是罕见的交易亮点

Other multinational players like Merck, AstraZeneca Plc and Roche Holding AG have also scooped up Chinese assets. In May, Pfizer Inc. set a new record as it announced a $1.2 billion upfront deal with 3SBio Inc. for a cancer drug similar to Akeso’s. These deals are increasing in both value and frequency, according to biopharma deal database DealForma, signaling confidence that China-originated drugs are competitive internationally and can bring in substantial revenue.
默克、 阿斯利康和罗氏控股等其他跨国公司也纷纷收购中国资产。今年 5 月，辉瑞公司宣布与三生制药达成一项 12 亿美元的预付款协议，以开发一种与康方生物类似的抗癌药物，创下新纪录。生物制药交易数据库 DealForma 的数据显示，这类交易的价值和频率都在增加，这表明人们相信中国本土药物在国际上具有竞争力，并能带来可观的收入。

The volume of potential candidates coming out of China means multinational companies, who have a constant need to add new products to the mix, can “cast their net wider than ever before,” Norstella’s Chancellor said.
诺斯特拉的校长表示，来自中国的潜在候选人数量意味着跨国公司可以“比以往更加广泛地撒网”，因为跨国公司需要不断增加新产品。

A key advantage that has fueled the rise of Chinese biotech firms is their ability to conduct research cheaper and faster at every step of the way, from lab experiments and animal testing to human trials.
推动中国生物科技公司崛起的一个关键优势是，它们能够以更低的成本、更快速地开展从实验室实验、动物测试到人体试验的每个研究步骤。

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Creating a new drug from scratch is notoriously time-consuming and expensive, and China's massive patient pool and centralized hospital network have become a significant accelerator. An analysis of the time taken for drugs to conduct various testing stages shows that doctors in China can recruit for trials much faster — for early trials for cancer and obesity drugs, they can complete patient enrollment in half the time compared to the US.
众所周知，从零开始研发一种新药耗时耗力，成本高昂，而中国庞大的患者群体和集中式医院网络成为重要的加速器。对药物各阶段测试所需时间的分析表明，中国医生可以更快地招募试验对象——对于癌症和肥胖症药物的早期试验，他们完成患者入组的时间是美国的一半。

The difference in costs means Chinese companies can afford to run multiple trials simultaneously to find a winner, or quickly launch new projects once a scientific idea is validated by other groups.
成本差异意味着中国公司可以同时进行多个试验以找出成功者，或者在一个科学想法得到其他团体的验证后迅速启动新项目。

Since 2021, China has become the top location for clinical research, initiating the largest number of new trials globally, according to GlobalData.
根据 GlobalData 的数据，自 2021 年以来，中国已成为全球临床研究的首要地点，启动了全球最多的新试验。

“They can leapfrog competitors in other countries,” said Andy Liu, head of China at Novotech Health Holdings, which helps companies run clinical trials.
“他们可以超越其他国家的竞争对手，”帮助公司开展临床试验的 Novotech Health Holdings 中国区负责人 Andy Liu 表示。

To be sure, clinical data in China is just a start. US regulators have made it clear that China-only trial results, no matter how positive, are not sufficient to support drug approvals. Chinese biotechs with ambition to sell their drugs overseas must prove that their treatment benefits can be replicated in non-Chinese patients, through complex and slower-moving global studies.
诚然，在中国获得临床数据只是一个开始。美国监管机构已明确表示，仅在中国进行的试验结果，无论多么积极，都不足以支持药品审批。有意向在海外销售药品的中国生物科技公司必须通过复杂且进展缓慢的全球研究，证明其治疗效果可以在中国以外的患者身上复制。

It may still be a few years before a critical mass of drugs sourced from China wins US and EU approvals — the gold standard for high-quality treatments — and become widely used in the Western world, but many in the industry believe that's inevitable.
大量来自中国的药物可能还需要几年时间才能获得美国和欧盟的批准——高质量治疗的黄金标准——并在西方世界广泛使用，但许多业内人士认为这是不可避免的。

China’s innovators comprise both cutting-edge biotech startups founded by foreign-educated entrepreneurs, and old-guard Chinese pharmaceutical companies like Jiangsu Hengrui Pharmaceuticals Co., which used to be one of the country’s biggest generic drugmakers.
中国的创新者既包括由受过海外教育的企业家创办的尖端生物技术初创公司，也包括像江苏恒瑞医药股份有限公司这样的老牌中国制药公司，后者曾是中国最大的仿制药制造商之一。

The company poured billions of dollars into shifting to innovative research and development after Beijing’s campaign to lower generic drug prices made that sector less profitable. It's now the world's top-ranked pharmaceutical company for the number of new innovative drugs added to the research pipeline in the period of 2020-2024.
在中国政府降低仿制药价格的举措导致该领域利润下降后，该公司投入了数十亿美元转向创新研发。目前，就2020年至2024年期间新增创新药物研发数量而言，该公司已成为全球排名第一的制药公司。

Of the 50 companies that generated the highest number of innovative drug candidates between 2020 and 2024, 20 of them were Chinese, compared to five in the five years before.
2020年至2024年间，产生创新药物候选数量最多的50家公司中，有20家是中国公司，而之前五年只有5家。

“As we move forward, the fact that there’s high quality innovation in China in terms of biotech will no longer be a novelty,” said Ali Pashazadeh, founder and managing director of healthcare advisory firm Treehill Partners in London. “It’ll just be an accepted part of the norm.”
“随着我们不断前进，中国在生物技术领域拥有高质量创新的事实将不再是新鲜事，”伦敦医疗咨询公司 Treehill Partners 的创始人兼董事总经理阿里·帕沙扎德 （Ali Pashazadeh）表示。“这将成为公认的常态。”

At a time when China and the US are engaged in renewed geopolitical spats, the growth of China’s biotech ecosystem is causing alarm among some American politicians and business leaders. A congressional commission warned that the US risks losing its leadership position in yet another industry critical to national security.
在中美两国地缘政治争端再起之际，中国生物科技生态系统的蓬勃发展正引起一些美国政界人士和商界领袖的担忧。美国国会的一个委员会警告称 ，美国有可能在另一个事关国家安全的关键行业中失去领导地位。

“Biotech is one of the forefronts of the US-China tech rivalry,” said Jack Burnham, research analyst at the think tank Foundation for Defense of Democracies. In addition to economic implications and possible military applications of biotech, China’s leverage on innovative therapies may be weaponized in a future conflict, he said, if Americans become dependent on those medicines.
“生物技术是中美科技竞争的前沿领域之一，”智库“捍卫民主基金会”的研究分析师杰克·伯纳姆表示。他表示，除了生物技术的经济影响和潜在的军事应用之外，如果美国人对这些药物产生依赖，中国在创新疗法方面的影响力可能会在未来的冲突中被武器化。

The perception of threat has spurred calls for the US government to stymie China’s biotech growth — through restrictions such as export controls on scientific equipment and barriers to investment — and boost the domestic biotech sector, including by changing the regulatory environment to emulate countries where clinical trials are run more quickly. Robert F. Kennedy, the US Secretary of Health and Human Services, recently pledged to “Make American Biotech Accelerate.”
这种威胁感促使人们呼吁美国政府遏制中国生物技术的发展——例如通过科学设备出口管制和投资壁垒等限制措施——并推动国内生物技术产业的发展，包括改变监管环境，效仿那些临床试验速度更快的国家。美国卫生与公众服务部部长罗伯特·F·肯尼迪最近承诺要“ 加速美国生物技术的发展”。

Despite the risks of the newly combative relationship between the world's two biggest economies, Chinese drugmakers like Akeso have set their sights on bringing their therapies to developed Western markets.
尽管世界两大经济体之间新近出现的对抗关系存在风险，但康方生物等中国制药商已着眼于将其疗法推向西方发达市场。

“The pharma industry is the best industry in the world,” Akeso Chief Executive Officer Michelle Xia said in an April interview. “At the end of the day, what we do benefits patients in China, in the US and all around the world.”
“制药行业是世界上最好的行业，”康方生物首席执行官夏晓玲在 4 月份的一次采访中表示。“归根结底，我们所做的一切都是为了中国、美国乃至全世界的患者。”