It’s not just AI. China’s medicines are surprising the world, too

不仅仅是人工智能，中国的医药产业也在惊艳世界

Its firms are at the forefront of cheaper, faster drug discovery

中国药企正以更低成本、更快速度领跑药物研发

Keytruda, a cancer medicine, ranks among the most lucrative drugs ever sold. Since its launch in 2014 it has raked in more than $130bn in sales for Merck, its American maker, including $29.5bn last year. 

可瑞达是一种抗癌药物，位列全球最畅销药品之列。自2014年上市以来，其美国制造商默克通过该药已斩获超过1300亿美元的销售额，仅去年就达295亿美元。

In September last year an experimental drug did what none had done before. In late-stage trials for non-small cell lung cancer, it nearly doubled the time patients lived without the diseasegetting worse—to 11.1 months, compared with 5.8 months for Keytruda.

然而去年9月，一款实验性药物取得了前所未有的突破：在针对非小细胞肺癌的III期临床试验中，该药将患者无进展生存期（即病情未恶化的时间）从可瑞达的5.8个月延长至11.1个月，几乎翻倍。

The results were stunning. So too was the nationality of the biotech company behind them. Akeso is Chinese.

这一结果令人惊叹，而研发该药的生物技术公司——康方生物——同样引人注目，因为它来自中国。

In recent months China’s progress in artificial intelligence has stunned the world. A quieter yet equally significant shift is under way in biotech. China has long been known for churning out generic drugs, supplying raw ingredients and managing clinical trials for the pharmaceutical world. 

过去几个月，中国在人工智能领域的突破引发全球关注。而在生物科技领域，一场同样意义深远的变革正在悄然发生。长期以来，中国以仿制药生产、原料药供应以及为全球药企提供临床试验服务著称。

But its drugmakers are now also at the cutting edge, producing innovative medicines that are cheaper than the ones they compete with. China has become the second-largest developer of new drugs, behind only America .

然而，如今中国药企已跻身创新药物研发前沿，生产出价格更低廉的同类产品。中国已成为全球第二大新药研发国，仅次于美国。

As a consequence, Western drugmakers are increasingly looking east for ideas. Because of expiring drug patents, they stand to lose as much as $140bn a year in sales by 2030. Last year nearly a third of the large licensing deals they struck—those worth $50m or more—were with Chinese firms, triple the share of 2020. 

受专利到期影响，西方药企到2030年或将面临每年高达1400亿美元的销售额损失。在此背景下，它们愈发将目光投向东方寻求创新。去年，西方药企达成的近三分之一大型授权交易（价值5000万美元以上）均与中国企业合作，这一比例是2020年的三倍。

LEK, a consultancy, estimates that during that time, the total value of drugs licensed worldwide from China rose 15-fold, to $48bn. In November Merck paid $588m to LaNova Medicines, another Chinese biotech firm, to secure rights to a therapy similar to that produced by Akeso.

咨询公司 LEK 的数据显示，同期全球从中国授权的药物总价值增长了15倍，达到480亿美元。去年11月，默克向另一家中国生物科技公司礼新医药支付5.88亿美元，以获得类似康方生物疗法的开发权。

China’s government identified biotech as a strategic priority nearly two decades ago. But it was not until 2015 that things really took off, after the drug regulator launched ambitious reforms. 

中国早在二十年前就将生物科技列为战略重点，但直到2015年，随着药品监管机构启动雄心勃勃的改革，行业才真正迎来腾飞。

It took on more staff and cleared a backlog of 20,000 drug applications in two years. Clinical trials were streamlined and brought into step with global standards. A study by Yimin Cui of Peking University and colleagues found that the time taken to approve the first round of human trials fell to 87 days, from 501 days before the reforms.

监管机构扩充人员队伍，两年内清理了2万份积压的药品申请；临床试验流程得到简化，并逐步与国际标准接轨。北京大学崔一民教授团队的研究显示，改革后，首次人体临床试验的审批时间从501天缩短至87天。

The changes coincided with a wave of returning “sea turtles”, the term for Chinese people who studied or worked abroad. China’s vast domestic market helped to attract big drugmakers to its shores, bringing know-how and talent. Easier listing rules gave biotech investors a clearer path to exit. Private funding for Chinese biotech firms rose from $1bn in 2016 to $13.4bn in 2021.

改革恰逢“海归潮”，大批曾在海外学习或工作的中国人才回国发展。庞大的国内市场吸引跨国药企纷纷在华设立研发中心，带来先进技术与管理经验。与此同时，上市规则的放宽为生物科技投资者提供了更清晰的退出路径。2016年至2021年，中国生物科技企业的私募融资从10亿美元激增至134亿美元。

With more brains and money, Chinese firms moved beyond copying Western drugs. Instead of waiting for patents to expire and making generics, they adopted a “fast-follower” strategy—taking known drugs and modifying them to improve safety, efficacy or delivery. 

有了资金与人才的支持，中国企业不再局限于仿制西方药物，而是转向“快速跟进”策略——在已知药物基础上进行改良，提升安全性、疗效或给药方式。

Drug development typically starts by identifying a target, usually a protein or gene linked to a disease. Scientists then search for molecules that can either block or boost the target’s function. Since fast-followers are not starting from scratch, they can run speedier, cheaper trials.

药物研发通常始于确定靶点（通常为与疾病相关的蛋白质或基因），随后科学家寻找能够阻断或增强靶点功能的分子。由于“快速跟进”策略无需从零开始，因此临床试验速度更快、成本更低。

Between 2021 and 2024 the number of Chinese drugs in development doubled to 4,391. Fast-follower and completely original treatments made up nearly 42% of the pipeline. 

2021年至2024年，中国在研药物数量翻番，达到4391种，其中“快速跟进”和完全原创药物占研发管线的近42%。

Helen Chen from LEK notes that China’s approach has been particularly effective in ADCs, a cancer medicine in which an antibody is attached to a payload of chemotherapy via a chemical linker. Since the treatment’s core components already exist, success depends on combining them in the most effective way. Ms Chen believes this is where Chinese firms thrive.

LEK 的陈海伦指出，中国在抗体偶联药物（ADCs）领域尤为成功。ADCs 是一种将抗体与化疗药物通过化学连接子结合的抗癌药物，其核心组件已存在，成功关键在于以最有效的方式组合这些组件。陈海伦认为，这正是中国药企的优势所在。

Speed is another advantage, says Michelle Xia, founder of Akeso. “We can do things twice or even three times faster than anywhere else in the world,” she claims. Clinical trials—the longest and most expensive stage of drug development—are faster than in the West. A large patient population makes recruitment easy, and hospitals and doctors are incentivised by the government to support research.

康方生物创始人夏瑜表示：“我们的研发速度是全球其他地区的两到三倍。”临床试验是药物研发中耗时最长、成本最高的阶段，而中国凭借庞大的患者群体，使招募受试者变得更为容易；同时，政府激励医院和医生支持科研，进一步加速了临床试验进程。

Faster trials have made Chinese drugs even more attractive to global drugmakers. Though the clinical information is from mostly Chinese patients, rather than a wider sample, it helps investors and pharma firms spot promising treatments. 

更快的临床试验使中国药物对全球药企更具吸引力。尽管临床数据主要来自中国患者，但这些数据有助于投资者和药企识别具有潜力的疗法。

And as the quality of data from China has improved, regulators are paying attention. Results from Akeso’s Chinese trials were strong enough to convince America’s Food and Drug Administration to move the drug straight to late-stage trials.

随着中国数据质量的提升，监管机构也开始予以关注。康方生物的临床试验结果甚至说服美国食品药品监督管理局（FDA）直接批准其药物进入III期试验。

Few Chinese firms sell drugs in America directly. Instead they tend to strike licensing deals: a company sells the rights to market its drug outside China for an upfront payment and other fees. Akeso’s Keytruda rival was licensed to Summit Therapeutics, an American biotech, for $500m upfront, with up to $5bn in additional payments and a share of royalties.

目前，中国企业直接在美国销售药物的情况较少，更倾向于通过授权协议实现海外布局：企业将药物海外市场的销售权授予合作伙伴，换取首付款和其他费用。例如，康方生物的可瑞达竞争对手药物以5亿美元首付款、最高50亿美元里程碑付款及销售分成的方式授权给美国生物科技公司 Summit Therapeutics。

Another approach is the “NewCo” model. This involves a Chinese pharma company spinning off its clinical assets into an American entity run by an experienced local management team. The parent firm retains partial ownership, allowing it to benefit beyond royalties if the drug succeeds. Jefferies, an investment bank, says that about eight such companies have been formed since May.

另一种模式是“NewCo”模式：中国药企将临床资产剥离至由经验丰富的本土管理团队运营的美国实体，母公司保留部分股权，以便在药物成功时获得超越版税的收益。投资银行 Jefferies 数据显示，自5月以来，已有约8家此类公司成立。

China’s biotech boom is not without risks. The rise in licensing deals hides a funding crunch among young firms. Private investment in Chinese biotech fell to a seven-year low in 2024, mirroring a slowdown in global biotech markets. Investors are prioritising companies that generate cash or have strong international potential. 

中国生物科技产业的繁荣背后也暗藏危机。授权交易激增的背后，是初创企业面临的融资困境。2024年，中国生物科技私人投资降至七年来最低水平，与全球生物科技市场放缓趋势一致。投资者更青睐能够产生现金流或具有强大国际潜力的公司。

Jimmy Zhang, an investor based in San Francisco, worries that many of today’s licensing deals are a product of the past funding boom. Without fresh investment, he warns, China’s drug pipeline could start to run dry.

旧金山投资者吉米·张担心，当前许多授权交易是过去融资热潮的产物，若缺乏新投资，中国药物研发管线或将枯竭。

A bigger concern is rising tensions with America. Because drug prices in the world’s largest economy are less tightly controlled than they are at home, American patients are a big source of revenue for Chinese biotech firms.

更大的挑战来自中美关系紧张。由于美国药品价格管控相对宽松，美国患者是中国药企的重要收入来源。

So far America has only applied trade restrictions to high-tech goods; Chinese biotech has escaped similar scrutiny. An attempt to block Chinese firms from supplying some biotech services and equipment has stalled in Congress. But, with Donald Trump threatening to impose tariffs on pharmaceutical imports, biotech may not be able to escape unscathed for much longer. 

目前，美国仅对高科技产品实施贸易限制，中国生物科技尚未受到类似审查。一项试图阻止中国企业供应某些生物科技服务和设备的法案在国会受阻。然而，随着唐纳德·特朗普威胁对药品进口加征关税，生物科技领域或难以长期独善其身。

The approach of selling to America via licensing deals may only offer limited protection; already Chinese biotech firms are getting lower licensing fees for their experimental drugs than American counterparts, because of geopolitical risks. Impressive as the pace of Chinese innovation is, it will have to contend with some mighty geopolitical forces.

通过授权协议向美国销售药物的模式可能只能提供有限保护，受地缘政治风险影响，中国药企的实验性药物授权费用已低于美国同行。中国创新的速度固然惊人，但未来仍须与强大的地缘政治力量博弈。

（红色标注词为重难点词汇）

重难点词汇：

lucrative [ˈluːkrətɪv] adj. 有利可图的；赚钱的；获利多的

backlog [ˈbæklɒɡ] n. 积压的工作（或订单等）；未完成的事务

unscathed [ʌnˈskeɪðd] adj. 未受伤害的；未受损伤的；安然无恙的