What changed in the evidence

This feed records what a guideline body, a regulator, or a payer has done about an asset we keep a record for, each action dated, sourced, and placed on rungs 5–7 of the 12-rung ladder. Every entry is written after the action; nothing here is a forecast. Today that is a single asset, sunvozertinib, the subject of FF-001.

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Dated, sourced evidence changes

Newest first, each with its source, its date, and its rung.

2026-07-14 Rung 6: Regulatory action

Supplemental NDA submitted to FDA; Breakthrough Therapy Designation granted

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”.

The first-line indication now has a regulatory clock running. FF-001 is registered against the NCCN listing, a separate step.

AstraZeneca; US FDA and China CDE as recorded in the release

2026-05-27 Rung 6: Regulatory action

China's CDE accepts the first-line NDA and grants priority review

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”.

Recorded from the sponsor's release; a release is primary for what the sponsor stated, not for what the regulator did. The same row is on the evidence ledger with its archived copy.

China NMPA, Center for Drug Evaluation — as recorded by the sponsor