China Targets 65 Drugs in Its 12th National Procurement Round

On June 23, 2026, the National Joint Drug Procurement Office released Announcement No. 1 launching the 12th round of China's National Centralized Volume-Based Drug Procurement (VBP). Administered by the Shanghai Municipal Institute for Pharmaceutical Centralized Tendering and Procurement, the announcement establishes the final procurement scope while introducing stricter qualification requirements for participating manufacturers.

The announcement confirms 65 drug categories for inclusion in this procurement round, representing an estimated RMB60 billion (~US$8.8 billion) market, while excluding 12 products that met the preliminary competition and procurement scale thresholds. Importantly, inclusion in the procurement catalog does not make a product a "selected drug." Rather, it identifies the drug categories eligible to proceed through supplier qualification, competitive bidding, and final award.

With the submission and registration periods now closed, the procurement process has moved into qualification review, bid evaluation, and supplier selection.

What Is China's National VBP Program?

China's National Volume-Based Procurement (VBP) program is a government-led purchasing initiative designed to reduce medicine costs by consolidating demand across public healthcare institutions. Each procurement round follows a structured process.

1. Selection: Defining the scope of drug categories
2. Qualification: Assessing manufacturer eligibility
3. Bidding: Competitive price submission
4. Award: Announcement of the official "selected drugs" (中选药品)

While the 12th round’s catalog is finalized, the winning suppliers have yet to be determined. 

The 65-Product Catalog

The 12th round covers a broad range of therapeutic areas, including cardiovascular disease, oncology, infectious diseases, endocrinology, neurology, gastroenterology, anesthesiology, and critical care. The full list of these 65 categories can be found in Appendix 1 at the end of this article.

Key products include:

• Oncology: Carboplatin, Enzalutamide
• Anti-infectives: Ceftazidime/avibactam, Ertapenem, Vancomycin
• Cardio-Metabolic: Sacubitril/valsartan, Edoxaban, Dapagliflozin/metformin
• Gastroenterology: Vonoprazan

Each applicant must first satisfy the procurement office's qualification requirements before proceeding to competitive bidding.

Why 12 Products Were Excluded

Annex 2 identifies 12 products that initially met the preliminary competition and procurement scale criteria but were ultimately excluded. The exclusions fall into four categories, reflecting that VBP inclusion is no longer driven by volume alone; authorities also weighed patent certainty, clinical nuance and supply security:

• Patent-related barriers: Two products — including oral sacubitril/valsartan formulations and clopidogrel oral formulations — were excluded because of asserted patent disputes that prevented the procurement office from concluding that sufficient lawful competition existed. 
• Clinical differentiation: Three injectable products were excluded after expert review concluded that differences in clinical use prevented meaningful competition within a single procurement group. 
• Supply security: Several reproductive medicine products and nationally recognized shortage medicines were excluded because procurement authorities prioritized supply continuity over centralized price competition. 
• Insufficient competitive conditions: At least one product was excluded because it had not yet opened a competitive procurement channel, meaning the conditions for fair competition had not been established. 

Taken together, these exclusions suggest procurement authorities are willing to sacrifice short-term cost savings on individual products in order to protect broader policy goals – drug supply continuity and legal defensibility chief among them.

Navigating Patent Risk

The 12th round adopts a nuanced approach to intellectual property. Rather than applying a blanket ban on patent-sensitive drugs, regulators have permitted eight specific products (marked with "★" in Appendix 1) to participate, provided the applicant submits an Intellectual Property Undertaking and a non-infringement declaration.

The eight products are:

Among these, sacubitril/valsartan attracted particular attention after the China National Intellectual Property Administration (CNIPA) granted Novartis a five-year patent term extension on June 1, 2026, for the core crystal-form patent covering Entresto®, extending patent protection until November 8, 2031.

Rather than excluding the product, procurement authorities permitted participation subject to additional IP declarations. Under the procurement rules, companies that failed to submit the required documentation may face removal from provincial procurement platforms or restrictions on new provincial listings during the procurement agreement period unless the relevant patent expires.

This shift effectively forces firms to assume the legal risks associated with their participation. The stakes were underscored just before the announcement, when reports surfaced that an unnamed drugmaker had submitted a fabricated doctors' petition in an apparent attempt to resist VBP pricing pressure. While Novartis, Bayer, Takeda, and Eisai have all since denied involvement, the episode signals the intense scrutiny now surrounding this round.

Tighter Entry Requirements

The 12th VBP round further strengthens supplier qualification requirements. Eligible manufacturers were required to:

• Hold a valid Chinese marketing authorization issued on or before 23 June 2026
• Qualify through one of China's recognized quality pathways, including designation as a Reference Listed Drug (RLD), successful Generic Consistency Evaluation, approval under the revised chemical drug registration classification system demonstrating equivalence, or qualification as an imported reference product transferred to domestic manufacturing
• Demonstrate manufacturing experience for the same dosage form over at least two years between June 2021 and June 2026
• Maintain a clean GMP and regulatory inspection history between June 2024 and June 2026
• For imported generic products, provide evidence of GMP inspection by Chinese regulators in addition to overseas GMP certification

Procedural Clarity for Overseas MAHs

The announcement also provides greater procedural clarity for overseas Marketing Authorization Holders (MAHs). Foreign MAHs may participate directly or through an appointed China Domestic Responsible Person. Where no Domestic Responsible Person has been designated, companies may appoint a Chinese legal entity to act as their domestic agent during the procurement process.

Furthermore, the announcement clarified that for pending MAH transfers, both the current and prospective MAH must jointly submit applications and independently satisfy all qualification requirements.

Final Thoughts

The 12th VBP round marks a maturation of China's procurement policy. By integrating formal IP undertakings into the bidding process, regulators are signaling that patent-sensitive products can compete, but only if manufacturers are prepared to defend their legal position. For international pharmaceutical companies, that means building non-infringement documentation and IP risk assessments into the procurement timeline early, not treating them as a late-stage formality. For companies seeking pharmaceutical consulting for the Chinese market, contact Cisema today.

Further Information

• Explore Cisema’s pharmaceutical consulting services
• The official procurement catalogue (Appendix 1) and list of excluded products (Appendix 2) are available below

References

• ‍The 12th batch of official national procurement catalogs was released‍
• Announcement on the 12th National Centralized Volume-Based Drug Procurement (No. 1)‍
• Foreign drugmaker caught faking doctors’ petition to evade China’s price cut scheme

Appendix 1: Official Procurement Catalogue

Appendix 2: 12 Products Excluded from the 12th National VBP Round