---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-132299"
form_type: "8-K"
ticker: "ZYME"
cik: "0001937653"
company_name: "Zymeworks Inc."
filed_at: "2025-05-30T23:59:59+00:00"
generated_at: "2026-05-20T04:58:14.414932+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Zymeworks' zanidatamab wins NMPA conditional approval in China for HER2+ BTC; $20M milestone due

## Summary
- NMPA (China) conditionally approved zanidatamab for previously treated unresectable/metastatic HER2+ biliary tract cancer (IHC3+).
- Zymeworks receives $20M milestone from BeOne Medicines (formerly BeiGene); already received $61M in prior payments.
- Eligible for up to $144M in additional development/commercial milestones and tiered royalties up to 19.5% on net sales.
- Approval based on HERIZON-BTC-01 study showing overall survival benefit; confirmatory trials ongoing.
- Zanidatamab previously approved by FDA (Nov 2024); EMA CHMP positive opinion (Apr 2025) for same indication.

## SEC filing metadata
- accession: 0001193125-25-132299
- form_type: 8-K
- ticker: ZYME
- cik: 0001937653
- company_name: Zymeworks Inc.
- filed_at: 2025-05-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1937653/000119312525132299/0001193125-25-132299-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1937653/000119312525132299/d18018d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-132299
- JSON: https://secwatch.observer/filing/0001193125-25-132299.json
- Plain text: https://secwatch.observer/filing/0001193125-25-132299.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.