{"filing":{"accession_number":"0001104659-26-109485","cik":"0001818838","ticker":"ADAG","company_name":"Adagene Inc.","form":"6-K","filing_date":"2026-09-22","report_date":"2026-09-22","primary_document":"tm2625845d1_6k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1818838/000110465926109485/tm2625845d1_6k.htm"},"events":[{"id":34190,"run_id":31458,"accession_number":"0001104659-26-109485","anchor_item_number":"EX-99.1","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"This press release announces NMPA (China's National Medical Products Administration) clearance of an IND application for ADG138, a novel bispecific T-cell engager, with Phase 1 studies expected to begin in Q4 2026. This is a material regulatory milestone and clinical development advancement for a platform-driven biotech company, but it does not fit the specific event categories of earnings release, M\u0026A activity, executive changes, or other named types. It represents a significant operational/clinical development milestone that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory trajectory.","company_name":"Adagene Inc.","ticker":"ADAG","filing_date":"2026-09-22","form":"6-K","submitted_at":null,"items":[{"id":37858,"accession_number":"0001104659-26-109485","item_number":"EX-99.1","item_title":"tm2625845d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"This press release announces NMPA (China's National Medical Products Administration) clearance of an IND application for ADG138, a novel bispecific T-cell engager, with Phase 1 studies expected to begin in Q4 2026. This is a material regulatory milestone and clinical development advancement for a platform-driven biotech company, but it does not fit the specific event categories of earnings release, M\u0026A activity, executive changes, or other named types. It represents a significant operational/clinical development milestone that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory trajectory.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-22T12:02:21.285641+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":37858,"accession_number":"0001104659-26-109485","item_number":"EX-99.1","item_title":"tm2625845d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"This press release announces NMPA (China's National Medical Products Administration) clearance of an IND application for ADG138, a novel bispecific T-cell engager, with Phase 1 studies expected to begin in Q4 2026. This is a material regulatory milestone and clinical development advancement for a platform-driven biotech company, but it does not fit the specific event categories of earnings release, M\u0026A activity, executive changes, or other named types. It represents a significant operational/clinical development milestone that would affect a reasonable investor's assessment of the company's pipeline progress and regulatory trajectory.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-22T12:02:21.285641+00:00","company_name":"Adagene Inc.","ticker":"ADAG","filing_date":"2026-09-22"}]}