China Proposes New Restrictions on Biopharmaceutical Technology Exports, With Immediate Registration Requirements: Implications for Global Life Sciences Transactions and Investments

Executive Summary

On October 16, 2026, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly issued Announcement No. 48 of 2026, proposing new export restrictions on certain advanced biopharmaceutical technologies.¹ MOFCOM concurrently released an explanatory Q&A² addressing the scope and intended operation of the proposal.

The proposal seeks to add five new categories of biopharmaceutical technologies to China’s Catalogue of Technologies Prohibited or Restricted from Export (the “Catalogue”),³ including three prohibited categories and two restricted categories. These substantive restrictions are not yet final, and public comments are due by November 15, 2026.

Three Categories of Prohibited Technologies

The three categories of biopharmaceutical technologies prohibited from export are: (1) cell and gene therapy (CGT) technology platforms; (2) small interfering RNA (siRNA) drug technology platforms; and (3) technologies for artificial genetic modification and directed passage enhancement of pathogenic microorganisms. The proposal defines “technology platforms” as reusable, foundational technologies accumulated through long-term R&D that can support the development of multiple drug products. Accordingly, technologies developed solely for a single therapeutic candidate fall outside the scope of the prohibition.

With respect to categories (1) and (2), the proposal provides two exceptions: (a) one exception permits out-licensing arrangements and outsourced research and manufacturing services if ownership of the relevant technology platforms is retained in China; (b) another exception is for certain technologies and processes associated with the development, testing, manufacturing, quality control, regulatory approval, and commercialization of individual drug products in cross-border business development transactions. These exceptions are significant because they allow for continued ex-China out-licensing activities that focus on licensing specific therapeutic candidates or using existing technology platforms to identify new candidates, provided that there is no ownership transfer.⁴ Nevertheless, parties should examine actual technology flows under these arrangements, particularly where Chinese biotechnology companies, research organizations, or contract development and manufacturing organizations provide proprietary know-how, process improvements, or technology-transfer packages to overseas partners.

Two Categories of Restricted Technologies

The proposal also restricts export of proprietary technologies for discovering and validating wholly novel targets for cell and gene therapies and siRNA drugs (collectively, “Restricted Technologies”). “Wholly novel targets” means biological drug targets that have not been publicly disclosed worldwide via patent filings, academic literature, public databases, industry materials, conferences, or other channels. Unlike prohibited technologies, Restricted Technologies may generally be exported subject to applicable licensing requirements described below. Accordingly, ex-China companies may still license Restricted Technologies from Chinese parties, but Chinese licensors must obtain an export license from the competent commerce authority before the technology is transferred and, in the interim, must complete the pre-export registration described below.

Immediate Operational Change: Interim Pre-Export Registration Requirement

Effective immediately as of October 16, 2026, and until the revised Catalogue is formally implemented, Chinese exporters of all biopharmaceutical technologies covered by the proposal must register through MOFCOM’s online technology trade management system before export. This requirement applies regardless of whether the proposed restrictions are ultimately adopted in their current form. The new requirement is framed as a registration rather than a separate discretionary approval process. However, certain procedural details remain unclear, including how the new requirement interacts with China’s existing technology export rules, which generally require that a contract for the export of freely exportable technology be registered with the competent commerce authority within 60 days after it becomes effective.⁵

Registrable exports include (i) transfers of technology ownership to foreign parties, including intellectual property assignments; (ii) licenses for use outside China; (iii) transactions resulting in a foreign party becoming the owner or actual controller of Chinese technologies; or (iv) other circumstances designated by MOFCOM. Information required includes (a) basic information on the technology exporter and the technology recipient, (b) the destination country or region, (c) the technology to be exported and its intended use, and (d) the estimated export value of the technology.

The registration requirement operates independently of the proposed prohibitions, but the proposal does not specify the consequences of failing to register, whether or when MOFCOM will respond to a submission, or how much technical detail must be provided. Nor does it make registration a condition to the formation or effectiveness of the underlying agreement.

Notably, the registration requirement expressly covers technology exports that commenced before October 16, 2026, but have not yet been completed. Previously signed agreements, including ongoing technology transfers under existing collaborations, may therefore be subject to registration before any further transfer occurs.

Implications and Practical Considerations for Global Life Sciences Transactions and Investments

This latest MOFCOM and MOST proposal reflects an effort to exert greater regulatory oversight with respect to the international transfer of strategically important technologies while preserving significant avenues for cross-border biopharmaceutical collaboration. As the proposed restrictions may change through the consultation process, important questions remain regarding the scope and implementation of the new proposal.

As a result, practical implications vary by transaction type. For companies primarily in-licensing specific Chinese-developed therapeutic assets, the proposal does not disrupt that licensing-driven model significantly beyond the registration requirement. For multinational pharmaceutical companies and investors pursuing ownership of Chinese biotech companies or proprietary technology platforms, the potential implications are more significant.

In addition, the proposal contemplates automatic licensing or other facilitative procedures for certain covered technologies, including in response to public health emergencies, to provide humanitarian relief, or where such technologies are used in cross-border research and development collaborations utilizing overseas resources.⁶ The details and timing of these procedures remain to be clarified.

With these parameters in mind, the following are key considerations for companies and investors pursuing China-related biopharmaceutical transactions:

Licensing of individual drug candidates should be largely unaffected. For ex-China pharmaceutical and biotech companies sourcing assets from China, conventional product-focused licensing appears largely preserved under the proposal. Nonetheless, parties should confirm whether the licensed technology falls within a covered category and therefore would require interim registration, and whether the license is unrestricted or subject to automatic-licensing procedures.

Deal structures preserving Chinese ownership of underlying platform technology may warrant consideration as an alternative to outright technology acquisitions. If the proposal is adopted, then outright acquisitions of platform technologies and offshore transfers of core platform assets that would result in foreign ownership could face significant restrictions. A license or strategic collaboration that preserves Chinese ownership of the underlying platform may be a more viable structure. This has practical consequences for M&A deal design. Buyers may need to shift from acquiring a target outright to structures such as asset-level licenses, options, profit-sharing or co-development arrangements, or acquisitions of ex-China rights to specific products, each of which may change valuation, deal timing, and the allocation of regulatory risk. Buyers should also expect regulatory conditions, longer timelines between signing and closing, and greater focus on what happens if registration or approval is delayed or denied. Importantly, structuring around the rules on paper may not be enough. Relocating IP, personnel, or management offshore before a sale may not take a transaction outside the proposal if the underlying technology was developed in China, and such steps may themselves be treated as a technology export. Because registrable exports include transactions in which a foreign party becomes the “actual controller” of Chinese technologies, the analysis is likely to focus on who controls the technology in practice, such as through board appointments, veto rights, or management control, rather than on legal title alone. It also remains to be seen how regulators will treat variable interest entity (VIE) structures, in which offshore entities control Chinese operating companies by contract rather than through equity, and whether such contractual control will be considered actual control for purposes of the proposal.

Private equity and venture capital investment considerations. The proposal does not establish a general prohibition on foreign investment in Chinese biotech companies, and minority investments are not categorically prohibited. However, because registrable transactions include changes resulting in foreign ownership or actual control, investments in companies developing covered technologies warrant additional diligence. Control rights, offshore IP structures, and anticipated exit strategies deserve particular scrutiny, as the rules could affect exit optionality, timing, and valuation for certain platform-focused investments. Selling a covered CGT or siRNA platform to a foreign buyer could require registration or could be prohibited if the proposal is adopted, which would narrow the pool of potential buyers and could lower exit valuations. Exits through offshore holding structures may also face added review. The China Securities Regulatory Commission’s (CSRC) recent increased oversight of offshore listings using “red-chip” structures suggests that holding China-developed technology through offshore entities may not avoid Chinese regulatory scrutiny of a later listing or sale. As with M&A transactions, regulators are likely to look at where the technology was developed and is controlled rather than the location of the holding company or management. Investors should therefore consider exit paths at the time of investment, including whether a licensing-based exit, a sale to a Chinese buyer, or a domestic listing may be more realistic. Separately, China’s foreign investment restrictions, such as the Foreign Investment Negative List⁷ (the “Negative List”), remain relevant. The Negative List in particular prohibits foreign investment in human stem cell therapies, genetic diagnosis, and gene therapies.

Targeted technology diligence and documentation. Deal teams should assess whether the relevant technology falls within a covered category; distinguish product-specific IP from reusable platform technology (as the proposal’s treatment of a transaction turns on whether the technology is a reusable platform or product-specific); and examine ownership and control rights. Particular attention should be given to acquisitions, option-to-acquire arrangements, platform improvement rights, offshore IP assignments, and transactions involving Chinese subsidiaries or IP-holding entities. Depending on the transaction, parties may consider representations, cooperation covenants, regulatory conditions, and allocation of risks relating to applicable technology-export registrations or approvals.

Immediate Next Steps

As next steps, companies and investors pursuing Chinese biotech assets should promptly review pending and ongoing transactions to determine whether any covered technology is involved and whether registration is required before any further technology transfer or change of control. Given the interaction between the proposed licensing exemptions and the interim registration requirement, careful China-law analysis is advisable. Interested parties may also wish to consider submitting comments to MOFCOM before the November 15, 2026 deadline.

Key Regulatory Sources

1. MOFCOM/MOST Announcement No. 48 of 2026 (October 16, 2026)
2. MOFCOM Official Explanatory Q&A (October 16, 2026)
3. Technology Import and Export Contract Registration Measures (MOFCOM Order No. 3 of 2009)

This Alert provides a general overview of recent developments and does not constitute legal advice concerning any particular transaction. The proposed amendments remain subject to public consultation, and their application will depend on the specific technology, contractual arrangements, and applicable Chinese law.