China NMPA approves ivonescimab + chemo for 1L squamous NSCLC
Chinese regulators approved Summit’s ivonescimab (SMT112) for 1L advanced squamous NSCLC (China) on Aug 12, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Summit Therapeutics Inc. SMMT
- Drug
- ivonescimab (SMT112)
- For
- 1L advanced squamous NSCLC (China)
- Stage
- Approved
- When
- Aug 12, 2026
- Source note
- Partner Akeso received NMPA marketing authorization in China for ivonescimab plus chemotherapy in first-line advanced squamous NSCLC, based on the HARMONi-6 trial. It is the third NMPA-approved indication for an ivonescimab regimen.
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- Checked by a person when it was added
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SMMT headlines on this site
Summit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic squamous NSCLC in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- HARMONi-3 squamous cohort final PFS analysis · Clinical trial results (readout / topline data)
- Drug
- Ivonescimab
- For
- First-line metastatic squamous NSCLC
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 PR: squamous cohort final PFS analysis events expected to be reached in second half of 2026, with interim OS analyses planned; enrollment complete.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SMMT headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is due to decide by Nov 14, 2026 whether to approve Summit’s Ivonescimab for EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
More details
- Entry
- PDUFA date for ivonescimab in EGFR-mutated NSCLC post-TKI · FDA decision due (PDUFA date)
- Drug
- Ivonescimab
- For
- EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy)
- Stage
- BLA under review
- When
- Nov 14, 2026
- Source note
- Company PR (Jan 29, 2026): FDA accepted the BLA based on Phase 3 HARMONi and set a PDUFA goal action date of November 14, 2026. First US BLA for a PD-1/VEGF bispecific. No advisory committee meeting announced as of Aug 20, 2026.
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- Checked by a person when it was added
- Verify it
- Source: smmttx.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SMMT headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Summit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic non-squamous NSCLC in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- HARMONi-3 non-squamous cohort PFS analysis · Clinical trial results (readout / topline data)
- Drug
- Ivonescimab
- For
- First-line metastatic non-squamous NSCLC
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Q2 2026 PR: non-squamous cohort PFS events expected to be reached in the first half of 2027.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SMMT headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page