{"schema_version":"secwatch.filing_event.v1","accession":"0001831283-23-000067","form_type":"8-K","ticker":"LIANY","cik":"0001831283","company_name":"LianBio","filed_at":"2023-04-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:40.975695+00:00","generated_at":"2026-06-16T21:37:29.566177+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"China NMPA accepts with priority review LianBio's NDA for mavacamten in oHCM","bullets":["NMPA accepted NDA for mavacamten for symptomatic obstructive HCM in adults; priority review granted.","NDA based on global Phase 3 EXPLORER-HCM trial and LianBio's Phase 1 PK study in Chinese volunteers.","Blinded preliminary safety data from ongoing Phase 3 EXPLORER-CN trial supported early filing; topline results expected mid-2023.","CEO states this is a pivotal moment as LianBio prepares to become a commercial-stage company."],"urls":{"canonical":"https://secwatch.observer/filing/0001831283-23-000067","json":"https://secwatch.observer/filing/0001831283-23-000067.json","markdown":"https://secwatch.observer/filing/0001831283-23-000067.md","text":"https://secwatch.observer/filing/0001831283-23-000067.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1831283/000183128323000067/0001831283-23-000067-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1831283/000183128323000067/lian-20230421.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T21:37:29.566177+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"}