{"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","discovered_at":"2026-05-14T18:04:13.752252+00:00","generated_at":"2026-06-28T00:35:20.443364+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"NMPA approves Zai Lab's NUZYRA as Category 1 innovative drug for CABP and ABSSSI","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-358580","json":"https://secwatch.observer/filing/0001193125-21-358580.json","markdown":"https://secwatch.observer/filing/0001193125-21-358580.md","text":"https://secwatch.observer/filing/0001193125-21-358580.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T00:35:20.443364+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}