过去两年，中美之间早期药物资产的流向变了性质。过去讲的是西方公司把产品授权引进中国，如今大规模上演的，是美国和欧洲公司把中国的创新授权出去。据行业追踪机构估算，2025 年签署的中国来源授权协议超过 150 笔，交易总金额逾 1,300 亿美元，首付款同比大幅上升。当辉瑞为一家中国开发企业的单个双特异性抗体支付据报达 12.5 亿美元的首付款时，市场便不再把这些资产看作廉价的替代品，而是创新的主要来源。Over the past two years, the flow of early-stage drug assets between China and the United States has changed character. What was once a story of Western companies licensing products into China has become, at scale, a story of American and European companies licensing innovation out of it. Industry trackers estimate that China-origin licensing agreements signed in 2025 exceeded $130 billion in total deal value across more than 150 transactions, with upfront payments rising sharply year over year. When Pfizer commits a reported $1.25 billion upfront for a single bispecific antibody from a Chinese developer, the market is no longer treating these assets as inexpensive alternatives. It is treating them as primary sources of innovation.

华盛顿的监管姿态也朝着同一个方向移动。FDA 高级官员曾公开撰文表示，该机构「积极欢迎并依赖」境外产生的高质量临床数据，其对境外试验机构的监督「不是保护主义」。FDA 还释放出更开放的信号：可以考虑以一项严谨的关键试验加上确证性证据来支持批准，并着手缩短进入首次人体试验的路径。这些变化都没有降低证据门槛。它们意味着，来自中国、文件记录完备的数据，正在按其本身的价值被审阅。The regulatory posture in Washington has moved in the same direction. Senior FDA officials have written publicly that the agency "actively welcomes and relies on" high-quality clinical data generated abroad, and that its oversight of foreign trial sites "is not protectionism." The agency has also signaled greater openness to approvals supported by one rigorous pivotal trial with confirmatory evidence, and has been working to shorten the path into first-in-human studies. None of this lowers the evidentiary bar. It does mean that well-documented data from China is being read on its merits.

中国的早期资产为什么这么快就具备了竞争力，可以从三点看。第一是速度。中国的早期临床试验往往启动和入组都更快，庞大的患者群体帮了大忙：一个分子已经拿到人体数据时，西方的同类项目可能还在准备阶段。第二是厚度。大批工程与临床人才集中在当下最重要的技术路线上，包括双特异性抗体和抗体偶联药物，脚下是同一十年里建起来的生物医学工程基础，涵盖工艺开发、生产制造和仪器设备。这份厚度背后有一个代际层面的事实：正在创办这些公司的科学家和创始人，许多人曾在西方的大学、实验室和受 FDA 监管的药企受训，之后回国创业。他们带回去的标准、习惯和人脉网络，是这个行业用十年而非一代人时间走向成熟的重要原因。第三是结构。中国自 2017 年起按 ICH 标准运行，于是数据包从起步就越来越多地按同一套标准来准备，在华盛顿、布鲁塞尔和北京都能接受审阅。不过有一点要直说：最前沿的、首创性的研究仍然来自西方国家。中国的上升体现在开发与执行的速度上，在于缩短与那道前沿之间的距离，而不是取代它。Three things explain why Chinese early-stage assets have become competitive so quickly. First, speed: early-phase trials in China can often be initiated and enrolled faster, helped by very large patient populations, so a molecule may arrive with human data while a comparable Western program is still in preparation. Second, depth: a large engineering and clinical workforce has concentrated on the modalities that matter most right now, including bispecific antibodies and antibody-drug conjugates, standing on a biomedical engineering base — in process development, manufacturing, and instrumentation — that was built over the same decade. Behind that depth sits a generational fact: many of the scientists and founders building these companies were trained in Western universities, laboratories, and FDA-regulated drug companies, and then went home to build. The standards, habits, and networks they carried back are a large part of why the sector matured in a decade rather than a generation. Third, structure: China has operated under ICH standards since 2017, so data packages are increasingly built, from the start, to be reviewed in Washington and Brussels as well as in Beijing. It should be said plainly, though: the most cutting-edge, first-in-class research still comes from Western countries. China's rise is in the speed of development and execution — in closing the distance to that frontier, not in replacing it.

美国读者最容易忽略的，不是科学本身，而是科学所处的语境。中方的决策，高层拍板往往很快，落到纸面又往往很慢；关系被期待走在文件之前，而不是跟在文件之后。卖方在名义价格上看似灵活，对这段合作在本国如何被表述，却可能极其在意。还有一点：许多这类公司成立不久，英文数据室的质量参差不齐，其程度远远超过资产本身质量的参差。交易很少败在分子上。它们败在翻译上，这个词的每一层含义都是如此。What American readers most often miss is not the science but the context around it. Decision-making on the Chinese side is frequently faster at the top and slower at the paper stage; relationships are expected to precede documents, not follow them. Sellers who appear flexible on headline price may care intensely about how a partnership is described at home. And because many of these companies are young, the quality of the English-language data room varies far more than the quality of the underlying asset. Deals rarely fail on the molecule. They fail on translation, in every sense of the word.

审查也在收紧，这是应该的。其中最关键的一点，是对临床数据本身的核实：源文件、GCP 合规情况、整个数据包前后是否一致，都必须查证，不能假定。关于数据完整性、检查准入和国家安全立法的疑问，如今已是双方尽职调查中的标准内容。这并不是远离这个市场的理由。恰恰相反，它是带着能流畅读懂两套体系的人进入这个市场的理由。Scrutiny is also rising, and it should. Above all, verification of the clinical data itself is critical: source documents, GCP compliance, and consistency across the whole data package have to be checked, not assumed. Questions about data integrity, inspection access, and national-security legislation are now a standard part of diligence on both sides. That is not a reason to stay away from this market. It is a reason to enter it with people who can read both systems fluently.

美格咨询成立于 2010 年，2016 年起从事跨境交易；近几年的工作，有很大一部分涉及处于 FDA 临床阶段的资产，以及中美之间的技术转移。我们的角色并不大：帮助每一方弄清对方真正的意思。在一个变化如此之快的市场里，这种理解，常常就是签下一份条款清单与闹出一场误会之间的差别。Megs was founded in 2010 and has worked on cross-border transactions since 2016; in recent years much of that work has involved FDA clinical-stage assets and technology transfer between China and the United States. Our role is a modest one: to help each side understand what the other side actually means. In a market moving this quickly, that understanding is often the difference between a signed term sheet and a misunderstanding.