中国现在承担了全球近三分之一的临床试验,高于十年前的5%,而中国生物科技股今年上涨了110%,涨幅是美国同行的三倍多。监管改革把人体试验审批时间从501天压缩到87天,使年度新药批准数量从2015年的11个增至2024年的93个,其中42%为本土研发。
为应对未来六年超3000亿美元专利悬崖,大型药企正与中国公司签订大额许可交易,例如辉瑞与3SBio达成高达12.5亿美元的癌症药合作,以及葛兰素史克与恒瑞达成最高120亿美元的肺病治疗合作。今年上半年,大型药企约三分之一的全球许可协议对象是中企,是2021年份额的四倍,而中国生物科技公司的估值不到美国同行的15%,预付款通常低约三分之二。
中国药企管线中逾40%已是改良型或同类首创疗法,中国公司在全球约160款减肥药研发项目中占近三分之一,即便中国2023年处方药市场仅约1250亿美元、为美国的六分之一。新药目前只占国内销量的五分之一,预计到2028年或升至三分之一,但激烈的降价压力、数据隐私摩擦以及美国FDA对只在中国开展试验药物的严格审查,使进军富裕海外市场既是最大机遇,也是最严峻考验。


Big pharma is responding to looming patent cliffs of over $300bn in revenues by striking large licensing deals with Chinese firms, such as Pfizer’s $1.25bn cancer-drug pact with 3SBio and GSK’s lung-disease deal with Hengrui worth up to $12bn. In the first half of this year, roughly one-third of all big-pharma global licensing agreements involved Chinese partners, four times their 2021 share, while Chinese biotech valuations remain under 15% of U.S. peers and upfront payments are about two-thirds lower.
More than 40% of China’s drug pipeline now consists of fast-follower and first-in-class therapies, and Chinese firms account for about one-third of the 160 obesity drugs in global development, even as China’s 2023 prescription-drug market of $125bn is only one-sixth of America’s. New medicines make up just one-fifth of domestic sales, potentially rising to one-third by 2028, and intense price pressure, data-privacy frictions, and stricter FDA scrutiny of China-only trials mean that breaking into richer foreign markets remains both the biggest opportunity and the hardest test.