Introduced in the House on June 2, 2026, the Biotech Investment National Security Act (BINSA) represents a bipartisan attempt to expand U.S. outbound transaction controls. If enacted, the legislation would amend the Comprehensive Outbound Investment National Security (COINS) Act framework, subjecting U.S. pharmaceutical licensing agreements, joint ventures, and equity investments involving Chinese biotech entities to formal Department of the Treasury review for the first time.[1]
While the bill references broad macroeconomic findings, the congressional press rollout accompanying the legislation directly targeted two recent mega-deals:
- Bristol Myers Squibb’s (BMS): A $15.2 billion multi-program collaboration with Jiangsu Hengrui Pharmaceuticals (May 12, 2026).[2]
- Pfizer: $10.5 billion oncology alliance with Innovent Biologics (May 28, 2026).[3]
By leveraging these multi-billion-dollar transactions as policy justification, Congress has signaled a move toward heightened regulatory scrutiny for cross-border life science deals.
The Strategic Value of Cross-border Pharma Deals
Cross-border licensing structures and collaborations are an established industry staple. For years, Western pharmaceutical giants have utilized these collaborations as a capital-efficient mechanism to replenish early-stage clinical pipelines. The financial structure of these transactions makes them attractive. Rather than requiring the massive upfront cash outlays typical of corporate acquisitions, their values are heavily weighted toward contingent, back-loaded developmental and commercial milestones. Historically, these cross-border asset transfers sat safely outside traditional CFIUS-style inbound investment screening. However, as the legislative climate shifts toward tracking the outbound flow of U.S. capital and technical know-how, this long-standing regulatory safe harbor may soon close.
The BMS and Pfizer Deals
BMS and Hengrui entered global strategic collaboration and license agreements covering 13 early-stage programs across oncology, hematology, and immunology: four assets originating from Hengrui, four from BMS, and five to be jointly discovered and developed.[4] BMS’s own press release states the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act, with closing expected in the third quarter of 2026.[5] A multi-program collaboration and license agreement that mixes cross-licensing, joint development, and retained co-rights, which is how BMS and Hengrui describe their five jointly discovered and developed programs, is close to the fact pattern the 2013 rule was written to reach. The broader point holds regardless of which specific provision triggered reportability here: A “collaboration” label does not by itself keep a pharmaceutical licensing deal outside HSR and has not been able to since 2013.
Pfizer and Innovent’s agreement covers 12 oncology programs, eight originated by Innovent and four proposed by Pfizer, spanning antibody-drug conjugates and multi-specific antibodies. Innovent will receive $650 million upfront and is eligible for up to $9.85 billion in milestones, bringing total potential value to $10.5 billion. Rights allocation varies by program. Four programs are licensed to Pfizer on a fully exclusive global basis, with no retained rights for Innovent. Four are exclusive to Pfizer outside Greater China, where Innovent retains development and commercial rights. The remaining four will be co-developed and co-commercialized by both companies in the U.S. and Europe, with profit sharing between the parties and Innovent retaining rights in Greater China.[6]
What BINSA Would Actually Do, and What It Would Not
BINSA is structured as an amendment to the COINS Act, which became law as part of the Fiscal Year 2026 National Defense Authorization Act. The COINS Act covers outbound U.S. investment involving semiconductors, artificial intelligence (AI), quantum information technology, high-performance computing, and hypersonic systems, and the Treasury is still developing implementing regulations.[7] BINSA would add biotechnology to that list, specifically pharmaceutical development, biologics manufacturing and clinical research and development, and would make licensing deals, joint ventures, and equity investments with Chinese covered persons subject to Treasury Department review. The bill directs the Secretary of Defense to report within 60 days of enactment on whether U.S. capital flows into Chinese biotechnology affect national security and military readiness and gives Treasury one year to issue implementing regulations.[8]
“Treasury Department review” does not mean an automatic block. The COINS Act framework sorts covered deals into two tiers: a “prohibited technology” tier, where the Treasury Secretary has authority to bar a deal outright, and a broader “notifiable technology” tier, which only requires advance notice to Treasury before a deal closes. Whether Chinese pharmaceutical deals would eventually land in the prohibited or the merely-notifiable bucket is a question BINSA leaves for future Treasury rulemaking, even if the bill itself becomes law. As introduced, the bill does not apply retroactively, and well-settled administrative law principles support prospective-only application of any resulting rule, meaning deals signed before enactment are likely to survive in some form even if BINSA becomes law.[9]
BINSA vs. The BIOSECURE ACT
BINSA represents a fundamentally different regulatory mechanism than the BIOSECURE Act, which became law on Dec. 18, 2025. BIOSECURE restricts federal agencies from contracting with, or funding. designated “biotechnology companies of concern,” targeting the CDMO and manufacturing supply chain. The statute focuses on government procurement and funding restrictions rather than cross-border pharmaceutical licensing transactions.[10]
Conversely, BINSA targets the exact licensing and collaboration models that BIOSECURE left untouched; the licensing and collaboration structure that BMS, Pfizer, and a long list of other large pharma companies have used to bring Chinese-originated assets into their pipelines.
A Broadening Regulatory Trend
BINSA is not a novel concept. In 2023, a bipartisan group introduced the National Critical Capabilities Defense Act, which would have enabled committee review of, as well as the ability to block, U.S. outbound investment.[11] While that legislation failed to pass, the surrounding environment has shifted since 2023. The enactment of BIOSECURE normalized the idea that biotechnology belongs in the same national security category as semiconductors and AI. The ideological shift, combined with a growing list of mega deals, gives BINSA more political traction than its predecessor. The current Congress has had a historically slow pace of enacted legislation, and any version of BINSA that becomes law will most likely need to ride a must-pass vehicle, the way BIOSECURE rode the NDAA, rather than pass as standalone legislation.
Cross-border biopharma activity has surged in recent years, with licensing and collaboration deals between Western and Chinese firms reaching roughly $136 billion in 2025, up from under $5 billion in 2020.[12] Activity extends far beyond Pfizer and BMS. AstraZeneca entered a collaboration deal in January 2026 with CSPC Pharmaceutical Group for a portfolio of injectable weight-management therapies, with $1.2 billion upfront and total potential value up to $18.5 billion across eight programs.[13] AbbVie disclosed two licensing deals with Chinese biotechs in the first two weeks of January alone, RemeGen for a bispecific antibody (up to $5.6 billion) and Zelgen for a T-cell engager (up to $1.2 billion).[14]
Implications for Pharmaceutical Companies and Counsel
The current regulatory environment raises issues that should be top of mind both for attorneys advising on these transactions and for the companies contemplating them.
Companies should take a hard look at pipeline strategy and weigh the added risk that comes with a heavily China-dependent pipeline. Should sourcing and investment be reweighted to favor greater geographic diversification across licensing targets? Does regulatory uncertainty diminish China’s perceived structural advantages, including faster clinical trial timelines and lower development costs, both factors that carry real weight as companies race to bring new and innovative drugs to market?[15] Companies weighing diversification would need to account for that trade-off explicitly.
A related question is how much existing China investment is actually at risk. BINSA itself would apply prospectively, and the COINS Act as currently written already excludes transactions completed before enactment, so a signed and closed deal is unlikely to be unwound outright. The more open question sits with Treasury’s separate rulemaking authority under the existing COINS Act, where retroactivity treatment has not been tested. Companies with ongoing capital commitments, follow-on funding tranches, or new investment flowing into China-based development under an existing collaboration should watch that track closely, since a completed deal being safe does not necessarily mean every future dollar committed under it is.
That uncertainty has direct drafting consequences. Deal teams should be building defined “adverse regulatory change” language into closing conditions and termination rights rather than tying them narrowly to BINSA’s enactment, since Treasury’s rule could move on its own timeline. Milestone and follow-on funding mechanics deserve particular attention, given that later tranches under an existing agreement may face different regulatory treatment than the deal as originally signed.
At minimum, regulatory uncertainty should be treated as a live variable in deal structure and given real attention in diligence now. Companies and counsel should not wait for Treasury’s rule or a floor vote on BINSA to start that work.
This article was first published by Law360.
Notes
[1] Maddox, Will. 2026. “As China Biotech Crackdown Calls Reverberate in Washington, the Pushback Gets Louder, Too.” Fierce Biotech. June 4, 2026. https://www.fiercebiotech.com/biotech/divisive-bill-seeks-add-biotech-industry-law-limiting-investment-chinese-industry. (accessed July 13, 2026)
[2] Bristol Myers Squibb. 2026 “Bristol Myers Squibb and Hengrui Pharma Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology, and Immunology.” Press Release, May 12, 2026, news.bms.com. (accessed July 13, 2026)
[3] Pfizer. 2026. “Pfizer and Innovent Biologics Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines.” Pfizer.com. 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-innovent-biologics-enter-global-strategic.
[4] Bristol Myers Squibb. 2026 “Bristol Myers Squibb and Hengrui Pharma Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology, and Immunology.” Press Release, May 12, 2026, news.bms.com. (accessed July 13, 2026)
[5] Ibid.
[6] Zubulake, Zachary. 2026. “Is the Pfizer-Innovent Deal the New Model for Global Drug Development?.” Pharmtech.Com. Pharmaceutical Technology. May 29, 2026. https://www.pharmtech.com/view/pfizer-innovent-deal-new-model-for-global-drug-development. (accessed July 13, 2026)
[7] H.R. 9102 (see note 1); COINS Act, enacted as part of the National Defense Authorization Act for Fiscal Year 2026.
[8] H.R. 9102, Sec 4 (Rulemaking) and Sec. 5 (Defense Department report requirement) and implementing regulation provisions.
[9] Freshfields. 2026. “China Biotech Deals Are in the U.S. Congress’ Crosshairs: Here’s What Life Sciences Companies Need to Know.” A Fresh Take blog, June 8, 2026. https://www.freshfields.com/en/our-thinking/blogs/a-fresh-take/china-biotech-deals-are-in-the-u-s-congress-crosshairs-heres-what-life-scienc-102n1aq. Accessed July 13, 2026.
[10] Latham & Watkins LLP. 2025. “BIOSECURE Act Becomes Law Limiting Grants With Biotechnology Companies of Concern.” Client alert, December 2025. Accessed July 13, 2026.
https://www.lw.com/en/insights/biosecure-act-becomes-law-limiting-grants-with-biotechnology-companies-of-concern;. Vision Life Sciences. 2026. “The BIOSECURE Act: Impact on Pharma Supply Chains.” February 16, 2026. Accessed July 13, 2026. https://visionlifesciences.com/insights/biosecure-act-pharma-impact-2026.
[11] O’Brien, Janet K. Kim, Sylwia A. Lis, Rob. 2023. “US Government Issues Executive Order Restricting US Outbound Investment in Advanced Technologies Involving ‘Countries of Concern’ (China).” Sanctions & Export Controls Update. August 11, 2023. https://sanctionsnews.bakermckenzie.com/us-government-issues-executive-order-restricting-us-outbound-investment-in-advanced-technologies-involving-countries-of-concern-china/.
[12] H.R. 9102, Sec. 2 (Findings); House Select Committee on the Chinese Communist Party, press release, June 2, 2026 (see note 1).
[13] AstraZeneca PLC. 2026. “AstraZeneca Agrees Obesity and T2D Deal With CSPC.” Press release, January 30, 2026. Accessed July 13, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-agrees-obesity-and-t2d-deal-with-cspc.html.; Fierce Biotech. 2026. “AstraZeneca returns to China’s CSPC for $18.5B obesity deal.” January 30, 2026. Accessed July 15, 2026. https://www.fiercebiotech.com/biotech/astrazeneca-returns-chinas-cspc-47b-obesity-deal
[14] AbbVie. 2026. “AbbVie and RemeGen Announce Exclusive Licensing Agreement to Develop a Novel Bispecific Antibody for Advanced Solid Tumors.” Press release, January 12, 2026. Accessed July 13, 2026. https://news.abbvie.com/2026-01-12-AbbVie-and-RemeGen-Announce-Exclusive-Licensing-Agreement-to-Develop-A-Novel-Bispecific-Antibody-for-Advanced-Solid-Tumors.; BioSpace. 2026. “AbbVie Challenges Amgen With $100M Upfront for Trispecific Lung Cancer Drug.” BioSpace. Accessed July 13, 2026. https://www.biospace.com/deals/abbvie-challenges-amgen-with-100m-upfront-for-trispecific-lung-cancer-drug.
[15] Riemenschneider, Kristen, and Madeleine Tavcar. 2026. “Life Sciences Round Up – Q1 2026.” Freshfields, April 6, 2026. https://blog.freshfields.us/post/102mp0x/life-sciences-round-up-q1-2026. Accessed July 17, 2026.
© Copyright 2026. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC, its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.
