By Fineline Cube The National Organized Drug Joint Procurement Office announced the 12th batch of national organized drug volume-based procurement (VBP) on June 23, 2026, including 65 products with strict submission deadlines and explicit handling of patent disputes that could impact market participation.
Procurement Timeline & Key Deadlines
| Milestone | Deadline | Extension Window |
|---|---|---|
| Drug Information Submission | June 26, 2026 (16:00) | 2 hours for modifications/supplements |
| Enrollment Completion | July 13, 2026 (16:00) | – |
| Enrollment Modifications | July 14, 2026 (16:00) | – |
| Eligibility Requirement | Must complete enrollment AND pass verification to participate in bidding | Late submissions deemed as waiver |
Patent Dispute Management Framework
Products with Active Patent Claims (8 total):
- Baricitinib
- Alogliptin
- Dapagliflozin/metformin
- Vonoprazan
- Sacubitril/valsartan
- Azilsartan
- Edoxaban
- Indobufen
IP Compliance Requirements:
- Enterprises must bear sole responsibility for intellectual property status of their products
- IP commitment letter or “non-infringement commitment” required before submission deadline
- Failure to submit commitment results in restricted listing on provincial procurement platforms
- Applies even to products already listed on platforms that choose to waive submission
Excluded Products Analysis (12 total)
Generic Consistency Evaluation Issues:
- Lidocaine/prilocaine topical ointment: Generic consistency evaluation channel not yet opened
Clinical Usage Grouping Concerns:
- Fluticasone inhalants
- Compound electrolyte injections
- Adenosine injections
- Rationale: Grouped based on clinical usage differences per expert panel; failed competitive landscape criteria
Insufficient Non-Infringement Commitments:
- Ibrutinib
- Crisaborole ointment
- Rationale: Patent disputes exist but insufficient enterprises provided non-infringement commitments
Critical Medication Protections:
- Ganirelix, cetrorelix, triptorelin: Critical assisted reproduction medications (excluded per department/expert recommendations)
- Methotrexate, cytarabine, nitroglycerin: National short-supply or clinically essential drugs prone to shortages
Strategic Market Implications
- Competitive Pressure: 65-product batch represents significant revenue exposure for multinational and domestic manufacturers
- Patent Strategy Impact: Clear signal that patent disputes will not automatically exclude products, but IP compliance is mandatory
- Supply Chain Security: Explicit protection of short-supply and critical medications demonstrates policy balance between cost control and supply assurance
- Market Access Risk: Provincial platform restrictions for non-compliant IP submissions create significant commercial consequences beyond VBP exclusion
Operational Requirements
Enterprises must submit comprehensive information during enrollment including drug production capacity, quality documentation, and pricing data. The two-hour extension window for modifications suggests authorities expect high submission volumes and potential technical issues, while maintaining strict overall deadlines to ensure procurement schedule adherence.
This 12th batch continues China’s systematic approach to pharmaceutical cost containment while introducing more sophisticated handling of intellectual property and supply chain considerations compared to earlier VBP rounds.
Forward-Looking Statements
This brief contains forward-looking statements regarding China’s healthcare procurement policies and market implications. Actual implementation may vary based on regulatory decisions, industry compliance rates, and evolving policy guidance.-Fineline Info & Tech