---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-158341"
form_type: "8-K"
ticker: "ZYME"
cik: "0001937653"
company_name: "Zymeworks Inc."
filed_at: "2024-06-10T23:59:59+00:00"
generated_at: "2026-06-01T05:23:49.114548+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# NMPA accepts zanidatamab BLA in China; Zymeworks earns $8M milestone from BeiGene

## Summary
- China's NMPA accepted BLA for zanidatamab in second-line HER2+ biliary tract cancer.
- Acceptance triggers $8 million milestone payment from partner BeiGene under Asia Pacific license.
- FDA previously granted priority review for same indication; PDUFA target date Nov 29, 2024.
- Zanidatamab is also being developed by Jazz Pharmaceuticals in the U.S.
- Milestone payment expected to be received following NMPA acceptance.

## SEC filing metadata
- accession: 0001193125-24-158341
- form_type: 8-K
- ticker: ZYME
- cik: 0001937653
- company_name: Zymeworks Inc.
- filed_at: 2024-06-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1937653/000119312524158341/0001193125-24-158341-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1937653/000119312524158341/d761396d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-158341
- JSON: https://secwatch.observer/filing/0001193125-24-158341.json
- Plain text: https://secwatch.observer/filing/0001193125-24-158341.txt

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