- China’s innovative-drug market is projected to exceed ¥1.3 trillion in 2026, with 2025 out-licensing deals reaching roughly US$135 billion and the first quarter of 2026 alone surpassing US$60 billion.
2026 年中国创新药市场规模预计突破 1.3 万亿元；2025 年对外授权交易总额约 1357 亿美元，2026 年一季度即突破 600 亿美元。- The 2026 Government Work Report named biopharmaceuticals an “emerging pillar industry” for the first time, and a revised drug-administration regulation effective 15 May 2026 introduces six-year data protection and seven-year rare-disease exclusivity.
2026 年政府工作报告首次将生物医药列为”新兴支柱产业”；2026 年 5 月 15 日施行的药品管理新规引入 6 年数据保护与 7 年罕见病市场独占。- Foreign pharma’s China role has shifted from “sell-in” to “license-in and co-develop”: multinationals now source early-stage assets from Chinese biotechs at an estimated 30%–40% of US development cost.
外资药企在华角色已从”卖药”转向”引进与共创”：跨国药企以约为美国 30%–40% 的成本从中国 Biotech 采购早期管线。- AstraZeneca, Novartis, Roche, Sanofi and Lilly have announced deep localisation commitments — AstraZeneca alone plans over ¥100 billion by 2030 in China R&D and manufacturing.
阿斯利康、诺华、罗氏、赛诺菲、礼来等已宣布深度本土化承诺——仅阿斯利康便计划 2030 年前在华投入超 1000 亿元用于研发与制造。- NMPA’s ICH alignment and priority-review pathways let China-discovered assets reach global markets faster, recasting China as an innovation “source” rather than only a “market.”
国家药监局与 ICH 接轨及优先审评通道，使中国发现的资产更快走向全球，将中国从单纯的”市场”重塑为创新”源头”。- Practical entry levers for foreign players are license-in partnerships, local R&D centres, in-China manufacturing, and active NRDL/VBP engagement — not import-only models.
外资企业的务实抓手是授权引进合作、本土研发中心、在华生产，以及主动参与医保目录/集采，而非单纯进口模式。
China’s innovative-drug market and the foreign-pharma China playbook (2026) | 2026 中国创新药市场与外资药企的中国策略
Overview
China’s innovative-drug sector has moved from “imitation-driven” to “innovation-exporting” in a matter of years, and 2026 is the year that shift became structural. The macroeconomic framing is unusually explicit: the 2026 Government Work Report named biopharmaceuticals an “emerging pillar industry” for the first time, placing the sector alongside integrated circuits, aerospace and the low-altitude economy. For foreign-invested pharmaceutical companies, the implication is that China is no longer just a sales territory to be supplied from overseas plants — it is now a discovery and development engine that multinationals are increasingly woven into.
This article maps the 2026 market size and deal landscape, explains why foreign pharma is “going Chinese” through license-in and co-development, details the localisation playbook foreign groups are deploying, and sets out practical entry levers. It is informational guidance, not regulatory or legal advice; confirm current rules with the NMPA and qualified PRC counsel.
Market context: scale, output and the BD boom
The market is large and still expanding. Industry estimates put China’s innovative-drug market at about ¥1.13 trillion in 2024, roughly ¥1.22 trillion in 2025, and a projected ¥1.3 trillion-plus in 2026. The growth story is less about volume than about structure: domestic innovative assets now dominate new approvals. The NMPA approved 76 innovative drugs in 2025 — up about 58% year-on-year, with domestically developed products accounting for more than 80% of the total. By mid-April 2026 the regulator had already cleared 13 innovative drugs for the year, including six first-in-class medicines, and by the end of the first quarter it had approved 10, eight of them domestic.
The pipeline is globally significant. At the end of 2025 China had 4,751 drugs in active research, about 33.7% of the global total — making it the largest single-country pipeline in the world. In next-generation modalities the lead is sharper still: as of late 2025 China contributed roughly 34% of early-stage next-generation-therapy pipelines globally, and led in antibody-drug conjugates (ADCs, ~54% share) and bispecific/multispecific antibodies (~48% share).
The defining commercial event of 2025–2026 is the outbound-licensing (BD) surge. Chinese drugmakers signed more than 150 out-licensing agreements in 2025 with total deal value above US$135 billion — the first time China surpassed the United States as the top source of such deals globally. The momentum accelerated into 2026: NMPA preliminary statistics show out-licensing deal value exceeded US$60 billion in the first three months of 2026, already nearly half of the prior full year’s total, and one industry tracker put Q1 2026 cross-border out-licensing at about US$61.4 billion, roughly 70% of global deal value that quarter. Deal structure is also evolving from single-asset licensing toward broader platform partnerships and NewCo structures that retain long-term upside for the Chinese originator.
Why foreign pharma is “going Chinese”
For most of the 2010s, a multinational’s China operation meant importing finished products and running local sales. That model is being replaced by deep integration into China’s discovery ecosystem. Three forces drive the change.
Cost-and-quality arbitrage. Bankers close to the market note that, for early-stage innovative assets, multinational “China sourcing” can cost an estimated 30%–40% of the equivalent US development cost while matching or beating efficacy — a combination that makes China a core pipeline source rather than a peripheral one. A senior JPMorgan healthcare banker has cited a multinational CFO’s view that, where the same pipeline can be sourced in China at a fraction of US cost with potentially superior outcomes, the choice is obvious.
A maturing, globally credible asset base. China’s regulatory system has converged with international standards: by the end of 2025 the NMPA had issued 71 ICH implementation announcements covering the full arc from early research to manufacturing quality control. Clinical-trial data generated in China under ICH-GCP now have a credible pathway to acceptance by the US FDA and EU EMA for global filings. China registered 5,173 drug trials in 2025, up nearly 99% from 2,602 in 2020, and patient recruitment cycles run shorter than the global average — a real operating-efficiency advantage for global programs.
Confidence expressed in cash. The headline license deals of 2025–2026 read like a roll-call of China-to-world transactions: CSPC signed a multi-project peptide partnership with AstraZeneca in January 2026; Sino Biopharm out-licensed a JAK/ROCK inhibitor to Sanofi for US$1.53 billion; Innovent extended its long-running Lilly alliance with a deal carrying US$350 million upfront and up to ~US$8.5 billion in milestones; and 3SBio’s PD-1/VEGF bispecific drew a record US$1.25 billion upfront from Pfizer. These are not one-off asset sales — they signal a structural re-rating of Chinese innovation as a global supply source.
The localisation playbook foreign groups are deploying
Foreign pharma is backing this strategic shift with capital and bricks. The pattern has moved from “light-asset sales offices” to “heavy-asset rooted platforms.”
R&D centres with real decision rights. AstraZeneca opened its sixth global strategic R&D centre in Beijing in October 2025 (a US$2.5 billion investment) and runs a parallel Shanghai engine; it plans to exceed ¥100 billion (about US$15 billion) of cumulative China R&D and manufacturing investment by 2030, including cell-therapy and radioligand-therapy bases in Shanghai and Guangzhou. Roche’s Shanghai innovation centre holds independent new-drug decision authority, with more than ten locally discovered molecules advanced to clinic, and its China Accelerator (launched 2021) had brought nearly 20 domestic biotech startups into its orbit by end-2024. Novartis operates three China R&D sites (Shanghai, Beijing, Suzhou) and, since 2024, has struck potential cooperation worth over ¥80 billion with Chinese innovators across cardiovascular, oncology, renal and neuroscience. Pfizer’s Beijing R&D centre, its third in China, anchors a “China-All-In” strategy embedding China in global early and pivotal Phase III programs.
Manufacturing upgraded to high-value categories. Sanofi broke ground on a Beijing insulin active-pharmaceutical-ingredient project (€1 billion) in October 2025 and opened a Chengdu innovation-and-operations centre in March 2026 (12,600 m², ~600 jobs). Lilly plans US$3 billion of China investment over the decade, including a US$200 million Suzhou expansion and Beijing/Shanghai incubators. Roche is building a Zhangjiang biopharma base (¥2.04 billion) and a Suzhou diagnostics plant (its largest single China investment). Novo Nordisk’s Tianjin site has drawn cumulative investment above ¥10 billion, with a further ¥4 billion quality-lab expansion completing in 2026.
Ecosystem co-creation over wholly-owned control. The dominant new mode is “capital + technology + ecosystem”: J&J’s JLABS Shanghai is among its largest global incubators; Bayer’s Zhangjiang co-creation platform targets small molecules, nucleic-acid drugs and AI drug discovery; AstraZeneca and CICC run a healthcare fund; and NewCo structures let Chinese originators retain upside while importing global capital and management. The logic, in one executive’s phrasing, is to “monetise current value while embedding into the global innovation network.”
2026 policy tailwinds
Beyond market pull, the policy environment in 2026 actively supports foreign participation.
- Emerging-pillar status. The 2026 Government Work Report’s explicit naming of biopharmaceuticals as a pillar industry signals sustained, cross-ministry support rather than a one-off stimulant.
- Stronger IP and exclusivity. A revised regulation implementing the Drug Administration Law took effect on 15 May 2026, introducing six-year regulatory data protection, seven-year market exclusivity for rare-disease drugs, and additional incentives for paediatric medicines — measures analysts say improve China’s attractiveness for global development partnerships.
- Faster access. New-drug clinical-trial review timelines have been compressed from 60 to 30 working days, and time from approval to NRDL inclusion has shortened to about one year, narrowing the commercialisation gap that previously discouraged multinationals from launching novel assets in China first.
- Openness under the 2026 action plan. The “Stabilising and Improving Foreign Investment” action plan (effective 1 July 2026) supports drug segmented-manufacturing rules and expands biotech and wholly-foreign-owned-hospital pilot regions — see the companion brief on pharma opening measures — reinforcing the message that foreign players are welcome across the value chain.
What foreign players should do next
- Reframe China as a source, not just a market. Build or buy access to Chinese discovery assets through license-in, platform partnerships and NewCo structures rather than relying solely on imported products.
- Plant R&D and manufacturing roots. Where the portfolio justifies it, establish or expand in-China R&D centres with local decision rights and high-value local manufacturing — this is now the expectation, not the exception.
- Engage the NRDL/VBP reality early. Reimbursement and volume-based procurement determine commercial viability for most drugs; model them as part of the entry case, not as downstream marketing.
- Leverage the regulatory convergence. Use ICH-aligned, China-generated data for global filings and consider China for simultaneous global trials to exploit speed and recruitment efficiency.
- Protect the downside. Pair deeper integration with robust IP, data-protection and compliance posture, given the higher capital commitment localisation entails.
Common pitfalls
- Treating China as a sales outpost. Groups that import only will miss the cost and speed advantages of Chinese discovery and risk being out-competed by locals and by peers who localised earlier.
- Assuming overseas approval substitutes for China registration. An FDA/EMA licence does not register a product in China; a separate NMPA pathway with Chinese data is still required.
- Under-resourcing local decision rights. Centres without real pipeline authority become expensive liaison offices; the winners grant China teams genuine development mandates.
- Ignoring reimbursement until launch. NRDL and VBP outcomes — not the registration grant — often decide commercial success.
- Over-concentrating in one modality. China’s strength is broad (ADC, bispecifics, GLP-1, cell therapy, radioligand), so a single-theme bet underuses the ecosystem.
Sources
- National Medical Products Administration (NMPA) — official portal: https://www.nmpa.gov.cn
- NMPA — English portal: https://english.nmpa.gov.cn
- 国务院《利用外资固稳促优行动方案》(2026-06, 商资发〔2026〕97号): https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
- 国务院新闻办发布会介绍利用外资固稳促优政策措施 (2026-06): https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
Related reading
- see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
- see also: Pharma opening measures under the 2026 action plan / 医药产业开放新措施
2026 中国创新药市场与外资药企的中国策略
概述
中国创新药产业在数年间完成了从”仿创结合”到”创新输出”的跃迁，而 2026 年正是这一转变固化为结构性的时点。宏观层面的定调尤为罕见：2026 年政府工作报告首次将生物医药列为”新兴支柱产业”，与集成电路、航空航天、低空经济并列。对在华外资药企而言，这意味着中国已不再只是由海外工厂供货的销售疆域，而是跨国药企日益深度嵌入的发现与开发引擎。
本文梳理 2026 年的市场规模与交易格局，解释外资药企为何通过授权引进与共创走向”中国化”，剖析外资集团正在部署的本土化打法，并给出务实的进入抓手。本文仅为信息参考，不构成监管或法律意见；请以国家药监局及合格中国法律顾问确认最新规则。
市场语境：规模、产出与 BD 热潮
市场体量庞大且仍在扩张。行业估算显示，2024 年中国创新药市场规模约 1.13 万亿元，2025 年约 1.22 万亿元，2026 年预计突破 1.3 万亿元。增长故事的关键在于结构而非规模：国产创新资产如今主导新获批品种。国家药监局 2025 年批准 76 款创新药，同比增长约 58%，其中国产占比超过 80%。截至 2026 年 4 月中旬，监管方年内已放行 13 款创新药，含 6 款首创新药；到一季度末已批 10 款，其中 8 款为国产。
研发管线具备全球分量。2025 年底，中国在研创新药达 4751 个，约占全球总量的 33.7%，是全球单一国家中最大的在研管线。在下一代疗法领域领先更明显：截至 2025 年三季度，中国贡献了全球早期下一代疗法管线的约 34%，并在抗体偶联药物（ADC，约 54% 份额）与双抗/三抗（约 48% 份额）领域领跑。
2025–2026 年最具标志性的商业事件是出海授权的爆发。2025 年中国药企签署对外授权协议超 150 笔，总交易额逾 1357 亿美元，首次超越美国成为全球第一来源地。势头在 2026 年加速：国家药监局初步统计显示，2026 年前三个月对外授权交易额突破 600 亿美元，已接近上年全年的半数；有行业跟踪机构测算一季度跨境对外授权约 614 亿美元，约占当季全球交易额的 70%。交易结构也正从单资产授权，演进为更广泛的平台合作与保留长期上行空间的 NewCo 模式。
外资药企为何”中国化”
在 2010 年代的大部分时间里，跨国药企的中国业务意味着进口成品加本地销售。这一模式正被深度融入中国发现生态所取代，背后有三股力量。
成本与质量的套利。 贴近市场的投行人士指出，对早期创新资产而言，跨国药企的”中国采购”成本可低至美国开发成本的 30%–40%，且疗效相当或更优——这一组合使中国从边缘来源变为核心管线来源。某资深摩根大通医疗健康银行家援引一家跨国药企 CFO 的观点：当同一管线能以美国几分之一的成本在华获取且可能疗效更优时，选择不言自明。
成熟且全球可信的资产基础。 中国监管体系已与国际接轨：截至 2025 年底，国家药监局已发布 71 项 ICH 实施公告，覆盖从早期研究到生产质量控制的完整链条。按 ICH-GCP 在中国生成的数据，已具备被美国 FDA、欧洲 EMA 接受并用于全球申报的可行路径。2025 年中国登记药物临床试验 5173 项，较 2020 年的 2602 项增长近 99%，且患者入组周期短于全球平均——这对全球研发项目是真实的运营效率优势。
以资金表达的信心。 2025–2026 年的重磅授权交易堪称中国走向世界的清单：2026 年 1 月石药与阿斯利康签署多肽多项目合作；中国生物制药以 15.3 亿美元将 JAK/ROCK 抑制剂授权给赛诺菲；信达延展与礼来的长期联盟，交易含 3.5 亿美元首付款及最高约 85 亿美元里程碑；三生制药 PD-1/VEGF 双抗更从辉瑞处拿下 12.5 亿美元创纪录首付款。这些不是一次性资产出售，而是对中国创新作为全球供给源的系统性重估。
外资集团正在部署的本土化打法
外资药企正以资本与实体落地为这一战略转向背书。路径已从”轻资产销售办公室”升级为”重资产扎根平台”。
拥有真实决策权的研发中心。 阿斯利康 2025 年 10 月启用北京全球战略研发中心（25 亿美元投资），并与上海引擎并列；计划 2030 年前在华研发与制造累计投入超 1000 亿元，含上海细胞治疗与广州放射偶联药物基地。罗氏上海创新中心拥有独立新药决策权，已有十余款本土发现分子推进至临床；其 2021 年启动的中国加速器截至 2024 年底已引入近 20 家本土 Biotech。诺华在华运营上海、北京、苏州三处研发站点，且自 2024 年以来与本土创新者的潜在合作规模超 800 亿元，覆盖心血管、肿瘤、肾脏与神经科学。辉瑞北京研发中心作为其中国第三家研发中心，承载将中国纳入全球早期与关键三期同步开发的”China-All-In”战略。
向高价值品类升级的制造。 赛诺菲 2025 年 10 月在京启动胰岛素原料药项目（10 亿欧元），并于 2026 年 3 月启用成都创新与运营中心（1.26 万平方米、约 600 个岗位）。礼来计划十年内在华投资 30 亿美元，含 2 亿美元苏州扩建及北京/上海孵化器。罗氏正建设张江生物制药基地（20.4 亿元）与苏州诊断工厂（其在华最大单笔投资）。诺和诺德天津基地累计投资已超百亿元，并追加 40 亿元质量实验室扩建于 2026 年完工。
以生态共创取代全资控制。 主流新模式是”资本+技术+生态”：强生 JLABS 上海是其全球规模最大的孵化器之一；拜耳张江共创平台聚焦小分子、核酸药物与 AI 药物发现；阿斯利康与中金设立医疗健康基金；NewCo 结构让中国原创方保留上行空间，同时引入全球资本与管理。用一位高管的话说，其逻辑是”在兑现当期价值的同时，嵌入全球创新网络”。
2026 年政策顺风
除市场拉力外，2026 年的政策环境主动支持外资参与。
- 支柱地位。 2026 年政府工作报告明确将生物医药列为支柱产业，意味着跨部委的持续支持，而非一次性刺激。
- 更强 IP 与独占期。 落实《药品管理法》的修订条例于 2026 年 5 月 15 日施行，引入 6 年数据保护、7 年罕见病市场独占及儿科用药额外激励——分析人士认为这提升了中国对全球开发合作的吸引力。
- 更快可及。 新药临床试验审评时限已从 60 个工作日压缩至 30 个，从获批到纳入医保目录的时间缩短至约一年，收窄了此前阻碍跨国药企在华首发新品的商业化落差。
- 行动方案下的开放。 《利用外资固稳促优行动方案》（2026 年 7 月 1 日落地）支持药品分段生产细则并扩大生物技术、外商独资医院试点区域——详见姊妹篇《医药产业开放新措施》——强化外资可全程参与价值链的信号。
外资企业应做的下一步
- 将中国重构为源头而非仅市场。 通过授权引进、平台合作与 NewCo 结构建立或买断对中国发现资产的触达，而非仅依赖进口产品。
- 植下研发与制造的树根。 若组合justify，应设立或扩地在华研发中心并赋予本地决策权，并布局高价值本地制造——这已成为预期，而非例外。
- 早介入医保/集采现实。 报销与带量采购决定多数药品的商业可行性，应作为进入论证的一部分，而非下游营销问题。
- 借力监管接轨。 用 ICH 接轨、中国生成的数据支撑全球申报，并考虑以中国承接全球同步试验，以利用速度与入组效率。
- 守住下行。 因本土化意味着更高资本承诺，须配套稳健的 IP、数据保护与合规体系。
常见误读
- 把中国当销售前哨。 仅做进口的企业将错失中国发现的成本与速度优势，并被本土企业及更早本土化的同行反超。
- 以为境外批准可替代中国注册。 FDA/EMA 许可不等于在中国注册；仍需走完国家药监局的独立路径并常需中国数据。
- 本地决策权投入不足。 没有真实管线权限的中心沦为昂贵联络处；赢家授予中国团队真正的开发授权。
- 上市前才想报销。 决定商业成败的常是医保目录与集采结果，而非注册批件。
- 单一赛道过度集中。 中国优势面广（ADC、双抗、GLP-1、细胞治疗、放射配体），单主题下注浪费了生态。
来源
- 国家药品监督管理局（NMPA）——官方门户：https://www.nmpa.gov.cn
- NMPA——英文门户：https://english.nmpa.gov.cn
- 国务院《利用外资固稳促优行动方案》（2026-06，商资发〔2026〕97号）：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
- 国务院新闻办发布会介绍利用外资固稳促优政策措施（2026-06）：https://www.gov.cn/lianbo/fabu/202606/content_7074496.htm
相关阅读
- 参见：医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
- 参见：医药产业开放新措施 / Pharma opening measures under the 2026 action plan