Specimen ledger
Sunvozertinib, first line, EGFR exon 20 insertion NSCLC
A launch team inside an HTA window or a BD team mid-transaction on this asset gets the record as it stands: every act the deciding institutions have put on the record about first-line use, each dated to the day its source carries, tied to an archived copy by its digest, and chained so an edit anywhere shows.
· Phase 0 · observation only · dated, sourced, hash-chained · 2026-09-06
- Asset
- Sunvozertinib (ZEGFROVY)
- Scope
- First-line use of sunvozertinib in EGFR exon 20 insertion mutation-positive NSCLC: the trial readout, its publication, regulatory filings and designations, and the guideline position, each as the institution or its recorder stated it.
- Runs
- 2026-05-27 → 2026-08-17
- Rows
- 8, over 6 archived sources and one registration
- Chain head
d668f1a1d4d15be44653f597be0cee53baea3bc129e5b544363446c58732c8b8
The record
What each institution put on the record, and when
In the source's own words where the wording matters. Where a fact is known only through a sponsor's release, the row says so: a release is primary for what the sponsor stated, not for what the institution did.
- China NMPA, Center for Drug Evaluation — as recorded by the sponsor
Dizal release: the CDE “has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY® (sunvozertinib)” in EGFR exon 20 insertion mutation-positive NSCLC, headlined as first-line treatment and “based on the results of WU-KONG28 study”.
- Dizal (sponsor)
Dizal announces WU-KONG28 phase 3 results. The release headlines that sunvozertinib “outperforms platinum-doublet chemotherapy” in first-line EGFR exon 20 insertion mutation-positive NSCLC, “presented as a Late-Breaking Abstract Oral Presentation (#LBA8500)” at ASCO 2026 “and simultaneously published in The New England Journal of Medicine”.
- The New England Journal of Medicine — PubMed record
Primary publication indexed: “First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations”, N Engl J Med, PMID 42212913, doi 10.1056/NEJMoa2604461. Archived as the PubMed record because the publisher served a bot-challenge page rather than the article.
- The ASCO Post — secondary reporting
Independent report of the same readout: “As reported at the 2026 ASCO Annual Meeting and in The New England Journal of Medicine by Zhou et al, the phase III WU-KONG28 trial has shown that first-line sunvozertinib improved progression-free survival vs chemotherapy” in EGFR exon 20 insertion mutation-positive NSCLC.
- Cancer Discovery — PubMed record
Commentary indexed: “Rare EGFRm NSCLC: More First-Line Options Emerge”, Cancer Discov 16(7), PMID 42224429, doi 10.1158/2159-8290.CD-NW2026-0061.
- AstraZeneca; US FDA and China CDE as recorded in the release
AstraZeneca announces an exclusive global license for sunvozertinib from Dizal. The release records that “a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE)” and that both “have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting”.
- NCCN NSCLC Guidelines Panel — as recorded by the sponsor
The same release records the guideline position at that date: sunvozertinib “is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option”. Subsequent therapy, not first line; the guideline itself requires registration and is not archived here.
- NextConsensus public registry Registration
Registration FF-001 recorded against this asset: a frozen proposition on NCCN first-line listing, availability cutoff 2026-07-31, resolution window to 2027-07-31, two named adjudicator roles. The hash on this row is the ledger hash minted over the frozen commitment; the registered record itself is on its own page and is not restated here.
Check it
How the chain is built, and what it does and does not say
Scheme nc-ledger-v1: each row's chain value is the
SHA-256 of the previous chain value, the row's date and its source
digest, concatenated with nothing between them; the first row's
previous value is the empty string. Recompute any step:
node -e "const {createHash}=require('node:crypto');const [p,d,s]=process.argv.slice(1);console.log(createHash('sha256').update(p+d+s).digest('hex'))" "<previous chainHash or empty>" "<date>" "<source sha256>"Digests are over archived copies, so a publisher editing a page after the fact makes the substitution visible. Recomputing the chain checks the ledger's integrity, not whether a source is true, and it is separate from the specification-hash tool.
- Safety and adverse-event signals never enter the corpus: efficacy and coverage evidence only.
- The observation layer is deterministic and open source: the same archived bytes give the same digest, and the record is checkable rather than a black box. That is tamper-evidence over an observation, not a claim that any reading of it is correct.
Guideline listing (NCCN, ESMO): offered on judgment, not a track record — calibration not yet demonstrated.
Chain head d668f1a1d4d1… · registered
record: FF-001.