OEG-ONC-002 · SUPPORTED

Ivonescimab with pemetrexed and carboplatin was approved in China for the defined post-EGFR-TKI non-squamous NSCLC indication.

Population-level regulatory status in China for EGFR-mutated locally advanced or metastatic non-squamous NSCLC progressing after EGFR-TKI; other populations, treatment lines, combinations, and jurisdictions are outside this claim.

Case
SE-ONC-NSQNSCLC-CN-001 · China Non-Squamous NSCLC Evidence Pathway
Claim
SE-ONC-NSQNSCLC-CN-001.IVONESCIMAB_APPROVAL
Current state
SUPPORTED
Evidence cut-off
2026-09-28
Last reviewed
2026-10-05

What is established

  • An official NMPA public record supports approval of ivonescimab with pemetrexed and carboplatin for the defined China indication.

What is not established

  • Approval for populations, treatment lines, combinations, or jurisdictions outside the regulator-defined scope
  • Comparative superiority or outcome claims beyond the cited evidence

What would change this

An official regulator record that changes, narrows, expands, suspends, withdraws, or corrects the approval status, label, combination, population, or treatment-line scope; or an authoritative correction or retraction of the cited regulatory source.

Qualifying boundary

Examples that may qualify

  • NMPA approval label or official indication update
  • Official regulator safety, suspension, withdrawal, or correction notice
  • Authoritative source correction tied to the cited approval

Examples that do not qualify

  • Manufacturer commercial copy
  • Media summary without a regulator record
  • Trial result alone without a regulatory action
  • Approval in another jurisdiction
  • Unverified drug database entry

Challenge this gap

Append-only

Public change log

Accepted evidence may result in a state change, no state change, or scope clarification. Earlier entries remain visible.

  1. 2026-10-05 · GAP_OPENED

    Initial open evidence gap published under Open Evidence Gap Protocol v0.1.

    StructEvidence