Shanghai, China – 11 Sep 2026 – The National Joint Procurement Office of Organized Drug Volume‑Based Procurement (JPO) has issued an announcement launching a price confirmation process for subtypes of compound amino acid injections that did not secure selection in the 12th round of nationally organized volume‑based procurement (VBP). Qualifying manufacturers that accept prices at or below a benchmark set at 1.8× the highest selected price of the comparable specification of compound amino acid 18AA‑Ⅶ injection may obtain “deemed selection” status – without agreed procurement volumes – through a time‑limited online window closing 23 September 2026.
Procurement Milestone
| Item | Detail |
|---|---|
| Issuing Body | National Joint Procurement Office (JPO) |
| Announcement Date | 11 Sep 2026 |
| Policy Type | Price confirmation for compound amino acid injection subtypes under the 12th national drug VBP |
| 12th VBP Timeline | Proposed selection results 31 Jul 2026; official publication 6 Aug 2026; agreed‑volume allocation to medical institutions completed 7 Sep 2026 |
| Price Benchmark | 1.8× the highest selected price of the comparable specification of compound amino acid 18AA‑Ⅶ injection (incl. 18AA‑Ⅶ‑SF), adjusted for each subtype’s specification, usage volume and price‑comparison relationship |
| Registration Window | 14 Sep 2026, 09:00 – 17 Sep 2026, 12:00 (material amendments until 17:00, 17 Sep) |
| Price Confirmation Window | 21 Sep 2026, 09:00 – 23 Sep 2026, 12:00; submitted prices are final and irrevocable; non‑submission equals waiver |
| Platform | National Healthcare Security Service Platform (fuwu.nhsa.gov.cn), using 12th‑round VBP enterprise accounts |
Price Confirmation Rules – “Deemed Selection” Conditions
A compound amino acid subtype is granted deemed selection (with no agreed procurement volume) only if all of the following are met simultaneously:
- Benchmark Test: Accepted price does not exceed the applicable price‑comparison benchmark (anchored to 1.8× the highest selected price of 18AA‑Ⅶ).
- Own‑Price Test: Accepted price does not exceed the manufacturer’s lowest national listed price for the same brand – excluding invalid listings such as “inactive zone” prices.
- All‑Specifications Test: Where a manufacturer produces multiple specifications of the same subtype (differing in content, fill volume or packaging), every specification must participate and satisfy both tests above.
- SF Equivalence: Specifications labeled “SF” and those without the SF designation are treated as the same subtype for price confirmation.
- All‑or‑Nothing Discipline: If any single specification of a subtype fails the rules, or if a company selectively participates with only part of its specifications, the entire subtype is deemed waived.
Scope, Exclusions & Eligibility
- Excluded Products: Compound amino acid 18AA‑Ⅶ injection itself (both selected and non‑selected in the 12th VBP); pediatric‑only subtypes (generic names marked “pediatric/children” or pediatric‑restricted labeling); products that are not reference‑listed preparations; and products that have not passed (or are not deemed to have passed) the generic quality and consistency evaluation (GQCE).
- Eligibility: Enterprises must meet the declaration qualifications of the 12th VBP procurement document (GY‑YD2026‑1); products must hold a valid domestic registration approval obtained by 11 September 2026 (inclusive).
- Submission Requirements: Registration materials (waived for subtypes already cleared in the 12th VBP registration phase), a price confirmation commitment letter, and each subtype/specification with its lowest national listed price backed by provincial platform screenshots. Where company‑submitted listing data conflicts with JPO verification, the JPO’s verified data prevails.
Compliance, Penalties & Market Consequences
- Red/Yellow Label Relief: Products granted deemed selection are exempt from red/yellow price‑risk labeling; existing red or yellow marks will be revoked by provincial procurement platforms as listed prices are adjusted to the confirmed level.
- Risk Labeling for the Rest: After price confirmation concludes, all non‑selected compound amino acid injection products – including 12th VBP non‑winners, non‑participants, and products ineligible for VBP or confirmation (GQCE‑excluded), but excluding pediatric subtypes – will be flagged red or yellow by JPO member units under listed‑price governance rules, warning hospitals of procurement risk.
- Credit‑Based Revocation: Deemed selection is terminated if a company is rated “seriously dishonest” or “particularly seriously dishonest” under the drug price and procurement credit evaluation system for kickbacks, tax violations, monopoly distribution control or similar misconduct.
- False‑Information Sanctions: Submitting falsified listing‑price information results in disqualification and potential placement on the “violation list.”
- Supply Obligations: Deemed‑selected products must mirror selected‑drug requirements, including full traceability‑code upload, timely supply and guaranteed delivery.
- No Late Additions: Subtypes that fail to obtain deemed selection receive no supplementation during the 12th VBP execution period; however, newly approved specifications accepting the rules may apply to the JPO for deemed‑selection status.
Market Impact & Outlook
- Extended Price Discipline: The mechanism drags non‑selected compound amino acid subtypes toward the 1.8× benchmark, tightening the effective price ceiling across the entire amino acid injection category beyond the formally selected 18AA‑Ⅶ products.
- Portfolio‑Level Bargaining: The all‑specifications, all‑or‑nothing rule forces manufacturers to align pricing across entire subtype portfolios, discouraging cherry‑picking and compressing arbitrage between specifications.
- Label Arbitrage Ends: The red/yellow flagging of holdout products – combined with label removal for compliant ones – creates a direct commercial incentive for hospitals to avoid non‑confirmed products, effectively marginalizing price‑resistant brands.
- Compressed Timeline: With registration closing 17 September and irreversible price submissions due 23 September, companies face a decision window of roughly two weeks to model pricing against both the benchmark and their own national lowest listed prices.
- Awarded Prices: Subtype‑level benchmark values and the highest selected price of 18AA‑Ⅶ were not disclosed in the announcement.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the price confirmation process, deemed‑selection outcomes, red/yellow labeling enforcement and supply compliance for compound amino acid injection subtypes under China’s 12th national volume‑based procurement. Actual results may differ due to risks including enterprise pricing decisions, JPO verification outcomes, credit‑rating actions, and subsequent policy adjustments by the National Healthcare Security Administration.-China Health Reform Pulse
Policy Source: https://www.smpaa.cn/gjsdcg/2026/09/11/24423.shtml