---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-358580"
form_type: "8-K"
ticker: "ZLAB"
cik: "0001704292"
company_name: "Zai Lab Ltd"
filed_at: "2021-12-16T23:59:59+00:00"
generated_at: "2026-06-28T00:35:20.443364+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# NMPA approves Zai Lab's NUZYRA as Category 1 innovative drug for CABP and ABSSSI

## Summary
- NMPA approved NUZYRA (omadacycline) for community-acquired bacterial pneumonia and acute bacterial skin infections.
- Approved as Category 1 innovative drug; locally manufactured in China; Zai Lab's fourth product approval in 24 months.
- NUZYRA offers IV and oral formulations, targeting multi-drug-resistant bacteria; first Zai Lab product outside oncology.
- Approval based on three Phase 3 studies in Chinese patients; NUZYRA previously FDA-approved and marketed by Paratek in US.

## SEC filing metadata
- accession: 0001193125-21-358580
- form_type: 8-K
- ticker: ZLAB
- cik: 0001704292
- company_name: Zai Lab Ltd
- filed_at: 2021-12-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1704292/000119312521358580/0001193125-21-358580-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1704292/000119312521358580/d26405d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-358580
- JSON: https://secwatch.observer/filing/0001193125-21-358580.json
- Plain text: https://secwatch.observer/filing/0001193125-21-358580.txt

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