China biotech has become a regular source of new assets for global pharma, while US policy, including the BIOSECURE Act enacted in December 2025 and a Treasury proposal of 22 October 2026 that adds biotechnology to outbound investment rules, is defining where those deals can go. This paper sets out what changed, what remains unsettled, and what US and European companies can plan for.
- China has set explicit targets
- Its 2026 to 2030 plan aims for China to account for at least 25% of the world's first in class drugs and for at least five Chinese drugs to reach $1 billion in global annual sales.[1]
- Large deals are recurring
- Pfizer, Bristol Myers Squibb, GSK, Merck, Novo Nordisk and Novartis announced deals with China based developers between May and early October 2026, and Pfizer, Bristol Myers Squibb and GSK each covered several programs or made repeat deals.[4][5][6][7][8][9][10]
- US policy draws boundaries
- The BIOSECURE Act restricts federal contracting with designated biotechnology companies of concern, and Treasury has proposed adding biotechnology to outbound investment rules under the COINS Act.[2][3]
- Licensing appears outside the proposed rule
- Licensing is not among the transaction types the proposal lists, and the rule is not final.[11]
- Evidence decides portability
- FDA expects foreign trial data to meet the same standards as US data.[12]
- The FDA is testing faster first in human trials
- Its Expedited IND Pilot expects to select 8 to 10 sponsor and institution pairs, with selections scheduled for 18 December 2026.[13][14]
Why these signals matter together
Recent developments in China's biopharma policy, cross border licensing, US regulation and early clinical development give global drugmakers a timely reason to revisit one planning question: how to evaluate, develop and commercialize innovation that increasingly comes from a wider set of ecosystems.
These developments come from different institutions and run on different timelines. China's five year plan is a long horizon statement of industrial ambition. Licensing agreements reflect company portfolio decisions. Treasury's rule is a proposal open for comment. The FDA's Expedited IND Pilot is a limited operational experiment. None of these caused the others. Their timing still adds useful context for decisions on asset sourcing, partnership structure, trial location, regulatory diligence and market access.
For US and European companies, the practical task is to engage China originated innovation with clear criteria. That means separating a promising molecule from a development package that can withstand US and EU regulatory review, and planning for a route from asset to therapy that depends on credible execution across science, evidence, policy and market readiness.
What China's 2026 to 2030 pharmaceutical plan targets
China's new plan for the pharmaceutical industry sets measurable goals for innovation output and global sales. Issued on 18 September 2026 by the Ministry of Industry and Information Technology and nine other authorities, it aims to keep China's biomedical research, development and application at the global forefront by 2030.[1]
Xinhua reported Li Yan, a researcher with the Development Research Center of the State Council, as saying that the 2026 to 2030 period will be pivotal for the industry's move from quantitative to qualitative growth.[1]
The targets are aspirations, and they do not guarantee commercial success in US or European markets. They matter because they place innovation output, industrial scale and global commercialization in the same policy frame. China is signaling an ambition to build companies, platforms and franchises that compete directly in global therapeutic markets.
If China's ecosystem keeps gaining capability across discovery, translational science, early clinical development, manufacturing and business development, the pool of assets available to global partners is likely to become larger and more diverse. Companies can treat that direction as strategically relevant without assuming every target will be met.
The plan pursues first in class innovation, industrial capability and global commercial reach together, as a single policy goal.
How global drugmakers are sourcing from China biotech
These deals suggest global drugmakers are moving from one off licenses toward repeat access to China based pipelines. Between May and early October 2026, six large companies announced deals with China based developers; Pfizer, Bristol Myers Squibb and GSK each covered several programs or made repeat deals.
- Bristol Myers Squibb Hengrui Pharma$600M up to about $15.2B
- Pfizer Innovent Biologics$650M up to $10.5B
- Novartis Abogen$575M up to about $7.2B
- Novo Nordisk Hengrui Pharma$300M up to $2.6B
- Merck SciBrunch Therapeutics$400M up to $2.13B
- GSK Hutchmed$110M up to $1.295B
- GSK Chimagen BiosciencesNot split up to $750M
Company announcements, May to October 2026 [4] to [10]. Bars drawn to one scale in billions of US dollars.
| Buyer, partner and date | Structure | Scope | Value |
|---|---|---|---|
| PfizerInnovent Biologics · 28 May 2026 | Licenses plus joint development in the US and Europe | 12 early stage and de novo oncology programs, including ADCs and multispecific antibodies | $650M upfront; up to $10.5B [4] |
| Bristol Myers SquibbHengrui Pharma · 12 May 2026 | Strategic agreements | 13 early stage programs in oncology, hematology and immunology | $600M upfront; up to about $15.2B [5] |
| GSKHutchmed · 3 Sep 2026 | Exclusive license outside Greater China | HMPL-A830, a KRAS-EGFR antibody targeted therapy conjugate | $110M upfront; up to $1.295B [6] |
| GSKChimagen Biosciences · 15 Sep 2026 | Acquisition of full global rights | Trispecific T-cell engager for multiple myeloma | Up to $750M [7] |
| MerckSciBrunch Therapeutics · 28 Sep 2026 | Exclusive global license | SPR2015, a preclinical oral KRAS G12D inhibitor | $400M upfront; up to $2.13B [8] |
| Novo NordiskHengrui Pharma · 29 Sep 2026 | Exclusive license outside Greater China | HRS-1596, a potential once weekly oral GLP-1/GIP receptor agonist for obesity and type 2 diabetes | $300M upfront; up to $2.6B [9] |
| NovartisAbogen · 2 Oct 2026 | Exclusive worldwide license plus options | ABO2203, an mRNA encoded CD19xCD3 T-cell engager for autoimmune disease | $575M upfront; up to about $7.2B in milestones if all options are exercised [10] |
Pfizer's May 2026 collaboration with Innovent Biologics covers 12 early stage and de novo oncology programs. Four are global licenses, four are licenses outside Greater China and four will be developed and commercialized jointly in the US and Europe.[4] The structure points to an appetite for repeated access to a portfolio, beyond a single pipeline addition.
Bristol Myers Squibb's agreements with Hengrui Pharma span oncology, hematology and immunology across 13 programs, including five to be discovered jointly.[5] Hengrui is also Novo Nordisk's partner for HRS-1596.[9] These deals do not show that every large company is adopting a China first strategy. They show that several experienced buyers will make multiple program, multiple year commitments when the science, portfolio fit and deal structure are compelling.
GSK adds a European perspective. BioPharma Dive counted five GSK deals with China based developers since the start of 2025, two of them in September 2026, a count that trails only Roche's.[15] The September deals were a license to Hutchmed's KRAS-EGFR conjugate HMPL-A830 and the acquisition of a trispecific T-cell engager for multiple myeloma from Chimagen Biosciences.[6][7] Hansoh Pharma's China only Phase 3 overall survival data in relapsed small cell lung cancer for risvutatug rezetecan, a B7-H3 antibody drug conjugate GSK licensed from Hansoh in 2023, were presented at the 2026 World Conference on Lung Cancer.[15][16]
Since late September, three more deals followed: Merck in oncology with a KRAS G12D inhibitor, and Novo Nordisk and Novartis beyond oncology, in obesity and in mRNA encoded T-cell engagers for autoimmune disease.[8][9][10] Gilead followed on 22 October 2026, agreeing to acquire an oral IL-23R inhibitor program led by the Phase 1 asset HCXT-2001 from Hong Kong based PepStar Therapeutics for $1.275 billion upfront.[17][18]
The external innovation question is moving from which asset to license toward which relationships can provide repeat access to differentiated science.
For smaller US and European biotechs, this widens the comparison set. A program may now be judged against candidates generated and advanced in China based ecosystems as well as those from traditional Western clusters. Clear differentiation, and the ability to create value in US and EU development, regulation and commercialization, become as important as where the science began.
Why China developers seek global partners
China based developers appear to have commercial reasons to partner globally, because capturing the full value of innovative drugs at home remains difficult. Reimbursement listing in China usually comes with steep price cuts, and private insurers paid 7.8% of spending on innovative drugs and devices in 2025, according to an industry white paper cited by Bloomberg Opinion.[19] China's health insurance administration plans to expand the range of innovative drugs covered by commercial health insurance, so this balance may shift over time.[20]
Chinese companies can still build significant domestic franchises. A global partner can add development capital, shared execution risk, access to multinational trial infrastructure and a route into markets with different pricing and reimbursement. For a Chinese oncology, rare disease or advanced modality company, out licensing can finance and validate global ambition while keeping a share of long term value.
The China to West licensing model is supported by Western demand for new assets and by some China based developers' need to finance global development and reach value pools that are hard to capture at home.
If incentives on both sides stay aligned, China originated assets are likely to keep entering Western pipelines even as China strengthens its domestic system. The useful test for a prospective partner is whether the deal allocates global development, evidence generation, manufacturing, rights and commercial responsibility in a way that creates value for both parties.
What the BIOSECURE Act and the COINS Act mean for China biotech deals
US law now restricts federal contracting with designated biotechnology companies of concern, and Treasury has proposed adding biotechnology to outbound investment rules, while conventional therapeutic licensing remains outside the proposed rule for now.[2][3] Two measures enacted in the FY2026 National Defense Authorization Act on 18 December 2025 frame the debate.[2]
The BIOSECURE Act
The BIOSECURE Act restricts federal procurement, contracts and grants that involve biotechnology equipment or services from designated "biotechnology companies of concern".[2][21] The law names no companies. The Office of Management and Budget must publish its list by 18 December 2026, and prohibitions begin only after later guidance and a Federal Acquisition Regulation revision.[21] We found no published list as of 3 November 2026.
Separately, the Department of Defense added WuXi AppTec to its section 1260H list on 8 June 2026, and a federal judge granted a preliminary injunction against that designation on 7 August 2026; the injunction binds the Department of Defense only, and the Office of Management and Budget may still list WuXi under the BIOSECURE Act.[22] Companies that rely on China based contract research or manufacturing partners can use this period to map exposure across their supply chains.
The COINS Act and Treasury's proposed rule
The Comprehensive Outbound Investment National Security (COINS) Act codifies and expands US outbound investment controls.[2] On 18 September 2026, Reuters reported that Treasury was drafting rules likely to allow investment in Chinese drug candidates unless they relate to pathogens or biotechnology that could be weaponized.[23] On 22 October 2026, Treasury issued a proposed rule under the COINS Act and stated that "the Secretary has added biotechnology to the proposed regulations."[3]
The proposal applies to transactions such as equity investments, certain debt and joint ventures. Licensing deals are not specifically listed, according to Axios.[11] The rule is open for public comment until 7 December 2026 and is not final.[24] Law firms note that licensing combined with a joint venture or a transfer of technology or know how may need separate analysis.[25]
If that approach holds, it would amount to selective openness. Companies could continue to license China originated therapeutic programs but would need closer attention to the technology, rights structure, capital flows, manufacturing location, data access, technology transfer and any dual use implications.
China's proposed biotech export controls
China is also proposing limits on biotech technology leaving the country. On 16 October 2026, China's Ministry of Commerce and Ministry of Science and Technology proposed prohibiting outbound transfers of ownership of China owned technology platforms for cell and gene therapies and siRNA drugs, and requiring a license to export technologies that discover and validate wholly novel targets in those fields; comments are due by 15 November 2026.[26][27]
Conventional product licensing and CRO or CDMO services appear unaffected, while a platform license combined with a change of control needs close review, and pre export registration applies immediately.[26] For licensees and acquirers, deal structure may now need review under both US and Chinese rules.
Congressional scrutiny
Congressional scrutiny remains active. Representative John Moolenaar, chair of the House Select Committee on the Chinese Communist Party, asked Treasury in May 2026 to treat biotechnology as a prohibited technology and to give particular consideration to licensing of pharmaceutical IP.[28] In August 2026 he and Representative Ben Cline asked the FDA to decline China generated clinical trial data for IND, NDA and BLA submissions unless the FDA had audited the trial site in person within the last twelve months.[29]
In June 2026 Representatives Moolenaar and Dingell introduced the Biotech Investment National Security Act (BINSA, H.R. 9102), which would make US pharmaceutical licensing deals, joint ventures and equity investments with covered Chinese persons subject to Treasury review; it has been referred to the House Financial Services Committee and has not passed either chamber.[30][31] Conventional licensing can be commercially permissible and still attract legislative or reputational attention.
The policy question now includes whether a company can explain its data governance, site oversight, technology transfer and patient safety approach if a China linked transaction becomes politically visible.
For smaller companies, a China originated asset calls for early legal and policy diligence on rights structures, data sharing, supply relationships, equity links and downstream technology transfer. In this environment, transaction design is part of the asset strategy.
Why evidence decides whether an asset is portable
An asset is only as portable as the evidence behind it. A buyer can secure rights to a molecule quickly, but regulators must still be able to assess how studies were run. The FDA applies the same expectation to all foreign data, and has said that "Companies should not assume that there is a lower probability of FDA inspection by conducting studies abroad."[12]
Diligence on a China linked asset should confirm five points before a US or EU plan is built. Select a point to see what it asks.
01 Data access
Access to underlying data, and whether sites, investigators and source records are available for inspection.
02 Clinical relevance
Whether patient populations, comparators and endpoints translate to US and European clinical practice.
03 Bridging need
Whether an additional multinational study, a bridging program or a different control arm will be needed.
04 Manufacturing transfer
Whether manufacturing methods, quality systems and pharmacovigilance can be transferred and documented to US and European standards.
05 Label and reimbursement
Whether the evidence package supports the intended label and the reimbursement case in each target market.
In a global market for therapeutic assets, the unit of value is the molecule plus the evidence, quality systems and development rights needed to carry it into the intended treatment market.
The same principle applies to manufacturing and supply. A small molecule program may transfer simply. A biologic, cell therapy, gene therapy or complex conjugate brings heavier requirements for process knowledge, comparability, quality control, release testing and long term safety follow up. Clinical, regulatory, manufacturing and commercial diligence work best when they start before signing.
How the FDA is speeding up first in human trials
The FDA's Expedited IND Pilot aims to make the United States faster for first in human trials without changing evidence standards. Launched on 15 September 2026 under the HHS Operation TrialBlazer initiative, it pairs sponsors with qualified research institutions and allows rolling review of IND components.[13]
FDA leaders said the pilot's final design reflects public feedback on who should qualify.[32] The pilot keeps the evidence expected before a medicine enters human testing. It tests whether coordinated review can reduce avoidable delays and make first dosing more predictable for emerging companies.
Today, a first-in-human clinical trial can take years to initiate in the United States versus just months in China and Australia.
The premise is simple: We can move faster without lowering our standards.
The pilot has broader aims than a response to China, yet the FDA's own framing puts China and Australia in the comparison.[33] For smaller companies, the location of first in human trials affects capital needs, time to proof of concept, investigator relationships, later evidence and the credibility of a partnering story.
A US first, Europe first, Australia first, China first or hybrid approach will remain asset specific. The pilot will need to show real reductions in delay before it changes site selection broadly. Its launch shows that US regulators are treating speed and predictability in early development as capabilities to manage actively.
The emerging global development equation
Taken together, these developments describe a more connected global development system. China is building a supply of first in class medicines and globally competitive companies. Western drugmakers are accessing that supply through asset, platform and multiple program deals. Commercial conditions in China appear to support the case for global partnerships. US policy is drawing boundaries around sensitive capability transfer while, so far, leaving conventional licensing outside the proposed outbound rule. The FDA is addressing both confidence in overseas evidence and the speed of early development at home.
These moves differ in pace and certainty. China's plan is long horizon. Deals are company specific. Treasury's rule is a proposal. The BIOSECURE list is still to come. The FDA pilot is unproven. Each is relevant to portfolio, partnering, trial location and market entry decisions over the next several years.
The lasting advantage is likely to go to companies that source science globally while generating trusted evidence, working within policy boundaries and delivering a treatment model that works in the markets they serve.
What US and European companies should plan for
US and European companies can build an operating model that reflects the breadth of the global asset pool and is disciplined about converting an asset into a therapy for US and EU patients.
Six moves for US and European companies
- 01Widen competitive intelligence. Therapeutic area, modality and platform landscapes should include China originated programs that may be licensed, partnered or developed globally.
- 02Diligence the development package as well as the molecule. Assess raw data access, inspection readiness, audit rights, study relevance, intellectual property, manufacturing transfer, supply dependencies and likely US and EU bridging needs.
- 03Treat early development geography as a strategic choice. Speed matters, and so do patient access, site expertise, investigator networks, regulator interaction, evidence portability and the route to pivotal studies.
- 04Build policy monitoring into business development. Track the BIOSECURE list, the final COINS Act rule and congressional proposals, and assess data flows, technology transfer, manufacturing relationships, capital structure and dual use sensitivity for each deal.
- 05Make regulatory credibility visible. Inspection ready trials, transparent data governance, sound manufacturing plans, clinically relevant endpoints and an early access strategy help a program stand out to investors and partners.
- 06Use partnerships selectively. Allocate responsibility for development, manufacturing, evidence generation and commercial rights clearly enough to manage what emerges after the announcement.
The question is translation
The decisive issue for companies and regulators is likely to be translation: whether the science can be developed efficiently, supported by evidence that earns confidence, manufactured reliably and positioned as a therapy that clinicians, payers and patients can use. Origin still matters where it affects intellectual property, development history, policy exposure, manufacturing or evidence.
The industry has always depended on cross border science, capital and partnerships. In our view, what is changing is the scale and intent of China's participation, which makes China originated assets a regular part of Western portfolio strategy.
Frequently asked questions about China biotech deals
Sources: the 33 verified links behind this whitepaper
- 01
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https://english.www.gov.cn/news/202609/18/content_WS6aacf7d5c6d00ca5f9a0d410.html - 02
US Government Publishing Office, Public Law 119-60, National Defense Authorization Act for Fiscal Year 2026 (including the BIOSECURE Act and the COINS Act), 18 December 2025.
https://www.govinfo.gov/content/pkg/PLAW-119publ60/html/PLAW-119publ60.htm - 03
US Department of the Treasury, “Treasury Issues Proposed Rule to Implement Comprehensive Outbound Investment National Security Act,” 22 October 2026.
https://home.treasury.gov/news/press-releases/sb0667 - 04
Pfizer, “Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines,” 28 May 2026.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-innovent-biologics-enter-global-strategic - 05
Bristol Myers Squibb, “Bristol Myers Squibb and Hengrui Pharma Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology and Immunology,” 12 May 2026.
https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-and-Hengrui-Pharma-Announce-Strategic-Agreements-to-Advance-Innovative-Medicines-Across-Oncology-Hematology-and-Immunology-2026-EbQpaI6Zdc/default.aspx - 06
Hutchmed, “HUTCHMED Announces Licensing Agreement with GSK for KRAS-EGFR-Antibody Conjugate Cancer Therapy,” 3 September 2026.
https://www.hutch-med.com/hutchmed-gsk-licensing-agreement-kras-egfr-attc/ - 07
GSK, “GSK to acquire potential best-in-class T cell-engager (TCE) for multiple myeloma from Chimagen Biosciences,” 15 September 2026.
https://www.gsk.com/en-gb/media/press-releases/gsk-to-acquire-potential-best-in-class-t-cell-engager-tce-for-multiple-myeloma-from-chimagen-biosciences/ - 08
Merck, “Merck Enters into Exclusive Global License Agreement with SciBrunch Therapeutics for SPR2015, an Investigational Oral KRAS G12D (ON) Inhibitor,” 28 September 2026.
https://www.merck.com/news/merck-enters-into-exclusive-global-license-agreement-with-scibrunch-therapeutics-for-spr2015-an-investigational-oral-kras-g12d-on-inhibitor/ - 09
Novo Nordisk, “Novo and Hengrui Pharma enter exclusive license agreement for once-weekly oral GLP-1/GIP dual receptor agonist HRS-1596,” 29 September 2026.
https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=917052 - 10
Abogen, “Abogen Announces Licensing and Option Agreement with Novartis,” 2 October 2026.
https://www.abogenbio.com/news/company/news2026/277.html - 11
Axios, “Trump administration proposes new curbs on China biotech deals,” 23 October 2026.
https://www.axios.com/2026/10/23/trump-china-biotech-restrictions - 12
US Food and Drug Administration, “Good Clinical Practices Are Not Optional: The FDA’s Commitment to Human Subject Protections and Gold Standard Science in an Era of Global Clinical Research,” FDA Voices, page content current as of 2 September 2026.
https://www.fda.gov/news-events/fda-voices/good-clinical-practices-are-not-optional-fdas-commitment-human-subject-protections-and-gold-standard - 13
US Food and Drug Administration, “FDA Launches Expedited IND Pilot, Begins Accepting Applications,” 15 September 2026.
https://www.fda.gov/news-events/press-announcements/fda-launches-expedited-ind-pilot-begins-accepting-applications - 14
US Food and Drug Administration, “FDA Expedited Investigational New Drug (IND) Pilot Program,” page updated 16 October 2026.
https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development/fda-expedited-investigational-new-drug-ind-pilot-program - 15
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https://www.biopharmadive.com/news/biotech-charts-gsk-china-electra-ipo-scholar-rock/830514/ - 16
GSK, press release on risvutatug rezetecan Phase 3 overall survival data in China presented at WCLC 2026, 13 September 2026.
https://www.gsk.com/media/txxdafj4/gsk-wclc-ris-rez-data-press-release_final.pdf - 17
Gilead Sciences, press release on the agreement to acquire the investigational oral IL-23R inhibitor HCXT-2001, 22 October 2026.
https://www.gilead.com/news/news-details/2026/gilead-to-acquire-investigational-oral-il-23r-inhibitor-hcxt-2001-strengthening-its-inflammation-pipeline-in-ibd - 18
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https://biospectrumasia.com/news/25/28591/gilead-buys-oral-il-23r-inhibitor-programme-from-chinas-pepstar-for-1-27-b.html - 19
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https://english.www.gov.cn/news/202609/04/content_WS6a9a7481c6d00ca5f9a0d02f.html - 21
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https://www.arnoldporter.com/en/perspectives/advisories/2025/12/the-biosecure-act-becomes-law-in-the-united-states - 22
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https://www.reuters.com/world/us-weighs-allowing-most-pharma-licensing-deals-with-china-sources-say-2026-09-18/ - 24
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https://www.federalregister.gov/documents/2026/10/26/2026-21786/outbound-investment-security-program-regulations - 25
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https://www.hklaw.com/en/insights/publications/2026/10/outbound-and-down-biotech-joins-semiconductors-quantum-and-ai - 26
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Company, regulatory and government sources are used where available. Media reporting is cited for developments and should be read as reporting at the time, not as final policy.
This paper is a strategic perspective based on publicly available information as of 3 November 2026. It is not clinical, regulatory, legal, financial or investment advice. It does not claim that the developments discussed are causally linked or that stated policy targets will be met. Proposed rules, company statements and media reports should be checked against final primary materials before decisions are made.
Hero photograph: Mikhail Nilov / Pexels.