- CEO
- Ying Luo
- Full Time Employees
- 990
- Sector
- Health technology
- Industry
- Biotechnology
- Address
- Nihonbashi-Honcho YS Building Tokyo TY Japan 103-0023
- IPO Date
- Aug 31, 2007
- Business
- GNI Group Ltd. (TSE:2160) engages in the research, development, manufacturing, and commercialization of biopharmaceuticals and medical devices, primarily targeting fibrosis, oncology, orthopedics, and inflammatory diseases; the company offers Etuary (pirfenidone), a market-leading treatment for idiopathic pulmonary fibrosis (IPF) in China with ongoing Phase 3 trials for additional indications including dermatomyositis interstitial lung disease, systemic sclerosis-associated interstitial lung disease, pneumoconiosis, and diabetic kidney disease; Hydronidone (F351), a next-generation anti-fibrotic agent for chronic hepatitis B-associated liver fibrosis and metabolic dysfunction-associated steatohepatitis (MASH)-related liver fibrosis, completing Phase 3 trials in China and advancing Phase 2a in the US; an innovative targeted protein degradation (TPD) platform featuring novel E3 ligands under the uSMITE technology, with CG001419 (TRK degrader) in Phase 1/2 for solid tumors and pain management; and biomaterials solutions including viable bone allografts, demineralized bone matrix, cellular allografts, and orthobiologics products through subsidiaries Berkeley Advanced Biomaterials and Osderma Medical.
GNI Group Ltd. operates across three integrated segments—Pharma, Biotech, and Medtech—with multinational operations in China, the United States, and Japan; the company maintains pharmaceutical manufacturing and sales in China, orthobiologics manufacturing and sales in the US, and global headquarters with strategic development in Tokyo; founded in 2001 and headquartered at 2-2-2 Nihombashihoncho, Chuo-Ku, Tokyo, Japan, GNI Group oversees subsidiaries including NASDAQ-listed Gyre Therapeutics (GYRE.US) for pharma commercialization and late-stage assets.
Recent developments include the 2024 acquisition of Elutia's orthobiologics business unit for $15 million upfront plus up to $20 million in earnouts, expanding the medtech portfolio with viable bone matrix and human tissue allografts; a strategic collaboration with Astellas on the uSMITE TPD platform yielding $35 million upfront and potential $1.9 billion total value; reverse merger enabling Gyre Therapeutics' NASDAQ listing; Phase 3 topline results expected early 2025 for F351 in China; and robust FY2023 group revenue of JPY26.0 billion with operating profit of JPY13.1 billion, driven by 40% pharmaceutical growth from Etuary.