Developer · China

Yangtze River Pharmaceutical Group

One of China's largest privately held pharmaceutical companies, headquartered in Taizhou, Jiangsu (founded 1971; not publicly listed). Historically a generics and TCM powerhouse, it has been shifting into Class 1 innovative drugs; fazamorexant (YZJ-1139), its dual orexin receptor antagonist for insomnia approved by the NMPA in May 2026, is its fourth Class 1 innovative chemical drug and the first domestically developed DORA in China. Clinical development of fazamorexant ran through its wholly-owned R&D subsidiary Shanghai Haiyan Pharmaceutical Technology Co., Ltd., and the marketing authorization is held by subsidiary Jiangsu Haian Pharmaceutical.

en.yangzijiang.com ↗

1compound
1program
1indication
Approvedlead asset

Phase distribution

  • Approved1

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Catalysts · 0 upcoming · 2 reported

Recently reported

  • 2026-05-21met

    Fazamorexant (YZJ-1139)forInsomniaRegulatory

    NMPA approved fazamorexant tablets (孟平 / Mengping) for adult insomnia — the first domestically developed Chinese DORA.

    source ↗

  • 2025-09-10met

    Fazamorexant (YZJ-1139)forInsomniaFull results

    Pivotal Phase 3 (YZJ-1139-3-01, 1,034 randomized) results premiered at World Sleep 2025: significant improvement in objective and subjective sleep parameters within 14 days, sustained over 6 months; 0.6% AE discontinuation, no rebound insomnia or withdrawal.

    source ↗

Recent activity

  • May 21, 2026ReadoutFazamorexant (YZJ-1139)·InsomniametNMPA approved fazamorexant tablets (孟平 / Mengping) for adult insomnia — the first domestically developed Chinese DORA.source ↗
  • Sep 21, 2025Phase changeFazamorexant (YZJ-1139)·InsomniaFiled (NDA)NDA for fazamorexant submitted to the NMPA Center for Drug Evaluation (CDE). Date is an UPPER BOUND: the company's World Sleep Congress 2025 release (2025-09-21) states the NDA 'has been officially submitted'; one Chinese trade report (pharnexcloud) gives NDA acceptance as January 2025, which could not be confirmed against a primary source, so the earlier date is noted but not asserted.source ↗
  • Sep 10, 2025ReadoutFazamorexant (YZJ-1139)·InsomniametPivotal Phase 3 (YZJ-1139-3-01, 1,034 randomized) results premiered at World Sleep 2025: significant improvement in objective and subjective sleep parameters within 14 days, sustained over 6 months; 0.6% AE discontinuation, no rebound insomnia or withdrawal.source ↗
  • Dec 17, 2021Phase changeFazamorexant (YZJ-1139)·InsomniaPhase 3Pivotal Phase 3 study YZJ-1139-3-01 (NCT05525637) started: randomized, double-blind, placebo-controlled, multicenter study of 20 mg and 40 mg once nightly in insomnia disorder; 1,037 enrolled. Primary completion 2023-07-07.source ↗
  • Aug 4, 2019Phase changeFazamorexant (YZJ-1139)·InsomniaPhase 2Phase 2 dose-ranging study YZJ-1139-2-01 (NCT06680505) started in primary chronic insomnia disorder: 300 patients, 10/20/40/60 mg vs placebo, multicenter, double-blind. Completed 2020-09-30. Registered on ClinicalTrials.gov retrospectively.source ↗
  • Dec 1, 2017Phase changeFazamorexant (YZJ-1139)·InsomniaPhase 1First-in-human study YZJ-1139-1-01 (NCT06673927) started: single ascending doses 2-80 mg and multiple ascending doses 10-60 mg x 7 days in 104 healthy Chinese adults. Registered on ClinicalTrials.gov retrospectively (posted 2024); start date is the actual conduct date.source ↗

Competitive landscape

Other companies developing against Yangtze River Pharmaceutical Group's targets or indications.