It’s not just AI. China’s medicines are surprising the world, too
不僅僅是人工智慧,中國的醫藥也在驚豔世界
Its firms are at the forefront of cheaper, faster drug discovery
中國企業正站在更廉價、更快速的藥物研發前沿
Keytruda, a cancer-immunotherapy medicine, ranks among the most lucrative drugs ever sold. Since its launch in 2014 it has raked in over $130bn in sales for Merck, its American maker, including $29.5bn last year. 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 disease worsening—to 11.1 months, compared with 5.8 months for Keytruda.
Keytruda,這款癌症免疫治療藥物,是史上最賺錢的藥物之一。自2014年上市以來,它已為其美國製造商默克公司創造了超過1300億美元的銷售額,僅去年就達到295億美元。去年9月,一款實驗性藥物取得了前所未有的突破。在針對非小細胞肺癌的晚期臨床試驗中,它幾乎將患者無病情惡化的生存時間延長了一倍——達到11.1個月,而Keytruda僅為5.8個月。
The results were stunning. So too was the nationality of the company behind them. Akeso, a biotech firm, is Chinese.
這一結果令人震驚,而更令人驚訝的是,這款藥物背後的公司——康方生物(Akeso)是一家中國企業。
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. 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 (see chart 1).
近年來,中國在人工智慧領域的進步震驚了世界。而在生物科技領域,一場更為低調但同樣重要的變革正在進行。長期以來,中國以生產仿製藥、供應原材料以及管理全球製藥業的臨床試驗而聞名。然而,如今中國的製藥企業也站在了創新前沿,生產出比競爭對手更便宜的創新藥物。中國已成為僅次於美國的全球第二大新藥開發國(見圖1)。
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 the end of the decade. Last year nearly a third of their large licensing deals they struck—those worth $50m or more—were with Chinese firms, triple the share of 2020. LEK, a consultancy, estimates that during that time, the total value of drugs licensed in the West from China rose 15-fold, to $48bn (see chart 2). In November Merck paid $588m to LaNova Medicines, another Chinese biotech firm, to secure rights to a therapy similar to that produced by Akeso.
因此,西方製藥公司越來越多地向東方尋求靈感。由於專利藥物即將過期,他們預計到本世紀末,每年將損失高達1400億美元的銷售額。去年,他們簽訂的大型授權交易(價值5000萬美元或以上)中,近三分之一是與中國企業達成的,是2020年的三倍。諮詢公司LEK估計,在此期間,西方從中國獲得的藥品授權總價值增長了15倍,達到480億美元(見圖2)。去年11月,默克公司向另一家中國生物科技公司LaNova Medicines支付了5.88億美元,以獲取類似康方生物生產的療法的權利。
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 national drug regulator launched ambitious reforms. It took on more staff and cleared a backlog of 20,000 drug applications in just two years. Clinical trials were streamlined and brought into step with global standards. A study by Yimin Cui of Peking University and colleagues, published in Nature Reviews Drug Discovery, found that the time taken to approve the first round of human trials fell to 87 days, from 501 days before the reforms.
中國政府近二十年前就將生物科技列為戰略重點。但直到2015年,國家藥品監管機構啟動雄心勃勃的改革後,行業才真正騰飛。監管機構增加了人員,僅用兩年時間就清理了積壓的2萬份藥品申請。臨床試驗得以最佳化,並與全球標準接軌。北京大學崔一民及其同事在《自然·藥物發現評論》發表的一項研究發現,改革前,首輪人體試驗的批準時間為501天,而改革後縮短至87天。
The reforms coincided with a wave of returning “sea turtles”, the term for Chinese scientists who had studied or worked abroad. China’s vast domestic market added momentum, by drawing every major drugmaker to its shores, bringing know-how and talent. Easier listing rules gave biotech investors a clearer path to exit, making the sector more attractive. Private funding for Chinese biotechs rose from $1bn in 2016 to $13.4bn in 2021.
這些改革恰逢一波“海歸”潮——這一術語指的是曾在海外學習或工作的中國科學家。中國龐大的國內市場進一步推動了行業發展,吸引了所有主要製藥企業進入中國市場,帶來了技術和人才。更寬鬆的上市規則為生物科技投資者提供了更清晰的退出路徑,使該行業更具吸引力。中國生物科技企業的私人融資從2016年的10億美元增長到2021年的134億美元。
With more brains and money, Chinese firms moved beyond copying Western drugs. Instead of waiting for patents to expire and making identical generics, they adopted a “fast-follower” strategy—taking known drugs and modifying them to improve safety, efficacy or delivery. 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 trials at a fraction of the cost and speed.
隨著更多人才和資金的投入,中國企業已經超越了對西方藥物的簡單複製。他們不再等待專利到期並生產相同的仿製藥,而是採用了“快速跟進者”策略——在現有藥物的基礎上進行改進,以提升安全性、療效或遞送方式。藥物開發通常始於識別目標,通常是與疾病相關的蛋白質或基因。隨後,科學家尋找可以阻斷或增強該目標功能的分子。由於快速跟進者並非從零開始,他們能夠以更低的成本和更快的速度進行試驗。
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. Helen Chen from LEK notes that China’s approach has been particularly effective in a type of cancer medicine called ADCs, in which an antibody is attached to a payload of chemotherapy via a chemical linker. Since the core components of the treatment already exist, success depends on combining them in the most effective way. Ms. Chen believes this is where Chinese firms thrive.
從2021年到2024年,中國正在開發的藥物數量翻倍,達到4,391種。快速跟進者和完全原創的療法佔據了近42%的管線。LEK的Helen Chen指出,中國在一種被稱為抗體偶聯藥物(ADCs)的癌症治療領域表現尤為突出,該技術通過化學連接子將抗體與化療藥物結合。由於這種治療方法的核心成分已經存在,關鍵在於如何以最有效的方式進行組合。陳女士認為,這正是中國企業的優勢所在。
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 easier, and hospitals and doctors are incentivised by the government to support research.
速度是另一項優勢,康方生物(Akeso)創始人夏瑜(Michelle Xia)表示:“我們可以比世界上任何地方快兩倍甚至三倍。”她認為,臨床試驗——即藥物開發中最漫長且最昂貴的階段——在中國進行的速度比西方更快。龐大的患者群體使得招募更容易,而政府還激勵醫院和醫生支援研究。
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. And as the quality of data from China has improved, other 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 into late-stage trials.
更快的試驗使得中國藥物對全球製藥商更具吸引力。儘管臨床資料主要來自中國患者,而非更廣泛的樣本群體,但這仍然有助於投資者和製藥公司發現有前景的療法。隨著中國資料質量的提升,其他監管機構也開始關注。康方生物在中國進行的試驗結果足夠強勁,以至於美國食品藥品監督管理局(FDA)決定直接將該藥物推進到後期臨床試驗階段。
Few Chinese firms sell their drugs in America directly. Instead, they tend to strike licensing deals: a company sells the rights to market its drug outside China in exchange for an upfront payment, milestone-based fees, and royalties on future sales. Akeso’s Keytruda competitor was licensed to Summit Therapeutics, an American biotech, for $500m upfront, with up to $5bn in additional payments and a share of royalties.
很少有中國公司直接在美國銷售其藥物。相反,他們更傾向於通過授權交易:公司將其藥物在中國以外市場的銷售權出售,以換取預付款、基於里程碑的費用以及未來銷售的版稅。康方生物開發的Keytruda競爭藥物已授權給美國生物技術公司Summit Therapeutics,前期支付5億美元,並可能額外支付高達50億美元,同時康方生物還能獲得部分版稅收入。
Another approach is the “NewCo” model. This involves a Chinese pharma company spinning off its clinical assets into a separate 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, estimates that around eight such companies have been formed since May.
另一種方式是“NewCo”模式,即中國製藥公司將其臨床資產剝離出來,成立一個獨立的美國實體,由經驗豐富的當地管理團隊營運。母公司保留部分所有權,從而在藥物成功後,除了版稅收入之外還能獲得更多收益。投資銀行Jefferies估計,自5月以來,已有約8家公司採用這一模式。
China’s biotech boom is not without risks. The rise in licensing deals hides a funding crunch. 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. 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.
中國的生物科技繁榮並非沒有風險。授權交易的增加掩蓋了資金短缺的問題。2024年,中國生物科技領域的私人投資降至七年來的最低水平,這與全球生物科技市場的放緩相吻合。投資者更傾向於投資能夠產生現金流或具有國際潛力的公司。總部位於舊金山的投資者Jimmy Zhang擔憂,如今許多授權交易只是過去融資熱潮的產物。如果沒有新的投資,他警告稱,中國的藥物開發管線可能會逐漸枯竭。
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.
更大的擔憂是中美關係的緊張加劇。由於美國這個全球最大經濟體的藥品價格監管較為寬鬆,美國患者已成為中國生物科技公司重要的收入來源。
American trade restrictions apply to high-tech goods; Chinese biotech has so far escaped similar scrutiny. An attempt to block Chinese firms from supplying some biotech services and equipment has stalled in Congress. But, with Chinese trade firmly in Donald Trump’s sights, biotech may not be able to escape unscathed for much longer.
美國的貿易限制主要針對高科技產品,而中國的生物科技行業目前尚未受到類似的嚴格審查。國會曾嘗試禁止中國企業提供部分生物科技服務和裝置,但該提案目前擱置。然而,隨著唐納德·川普將中國貿易問題作為重點,生物科技行業或許難以繼續置身事外。
The approach of selling to America via licensing deals may offer limited protection; already Chinese biotech firms are getting lower licensing fees for their experimental drugs than American counterparts, because of perceived geopolitical risks. Impressive as the pace of Chinese innovation is, it will have to contend with some mighty geopolitical forces.
通過授權交易向美國市場銷售藥品的模式可能提供有限的保護。目前,中國生物科技公司在實驗性藥物的授權交易中獲得的費用低於美國同行,主要原因是地緣政治風險的影響。儘管中國的創新速度令人印象深刻,但它仍需面對強大的地緣政治挑戰。