GNI Group Ltd.
2160・Growth Market・Pharmaceuticals
Pharmaceutical Business
Core segment engaged in pharmaceutical R&D, manufacturing and sales centered on China and the US
| Period | Current | Previous | Change |
|---|---|---|---|
| Revenue (FY2026 1Q) | ¥3,973 million | ¥3,919 million (FY2025 1Q) | ↑ |
| Segment profit/loss (FY2026 1Q) | -¥2,408 million | -¥887 million (FY2025 1Q) | ↓ |
| Revenue (Full-year FY2025, ending December 2025) | ¥19,158 million | — | — |
| Segment profit/loss (Full-year FY2025, ending December 2025) | -¥4,005 million | — | — |
| YoY revenue change rate (FY2026 1Q) | +1.4% | — | ↑ |
Business Details
Gyre Pharmaceuticals (Beijing Continent) sells ETUARY (pirfenidone) as its flagship product in the Chinese market, while also advancing development of new drug candidates such as F351 (hydronidone). Its US subsidiaries Gyre Therapeutics and Cullgen handle clinical development in the US and China. The segment's business encompasses pharmaceutical research and development, manufacturing, sales, and contract research, with ETUARY, Etorel, and Contiva as its key products.
Recent Overview
F351 NDA acceptance and priority review designation, plus full consolidation of Cullgen, drove a sharp rise in upfront investment
In FY2026 1Q, pharmaceutical business revenue was ¥3,973 million (up 1.4% year on year), a modest increase, while segment loss expanded significantly to ¥2,408 million (compared to a loss of ¥887 million in the prior-year period). The main causes were increased initial promotional preparation expenses toward F351 commercialization, increased R&D expenses related to the US IND application, one-time costs such as advisory fees associated with the Cullgen acquisition, and increased stock-based compensation expenses. As a subsequent event, Gyre completed the full consolidation of Cullgen as a wholly owned subsidiary on May 4, 2026. F351's NDA was formally accepted by the CDE in May 2026, and review is expected to proceed under the priority review system.
Key Products
Growth Drivers
- Progress toward approval and launch in China under the priority review system following NDA acceptance for F351 (May 2026)
- Continued maintenance and recovery of ETUARY sales in the Chinese market (recovered to prior-year levels in FY2026 1Q)
- Revenue contribution from promotional rollout of new products Etorel and Contiva
- Integration of R&D framework and pipeline strengthening within Gyre following the full consolidation of Cullgen
- Planned start of CG001419's US Phase 2 clinical trial (acute pain following bunionectomy) in the first half of 2026
- IND application for F351's Phase 2 clinical trial targeting MASH-related liver fibrosis in the US (planned by end of 2026)
- Expansion of ETUARY indications (ongoing Phase 3 trials for CTD-ILD, pneumoconiosis, and RILI)
Risks
- Difficulty in formulating reasonable earnings forecasts due to uncertainty over the timing of F351's NDA approval and its expected price
- Elevated upfront investment costs remaining high due to F351 commercialization preparation, expenses related to the US IND application, and one-time costs related to the Cullgen acquisition
- Risk of segment profit/loss deterioration due to continued high levels of stock-based compensation expenses
- Impact on ETUARY's pricing and sales volume from China's Volume-Based Procurement (VBP) system
- Risk of delays or failures in Cullgen's clinical trial progress (CG001419, CG009301, etc.)
- Temporary accounting impacts associated with the full consolidation of Cullgen as a wholly owned subsidiary (impact on the consolidated statement of financial position and income statement currently being calculated)
- Impact on China and US operations from geopolitical risk (deterioration in US-China relations)
- Tax risks related to the CFC (Controlled Foreign Company) taxation system
Last updated: March 27, 2026