By Fineline Cube Huadong Medicine Co., Ltd. (SHE: 000963), a leading China‑based pharmaceutical group, announced an exclusive commercialization partnership with Guizhou Sinorda Biotechnology Co., Ltd. for Linaprazan glurate, a next‑generation potassium‑competitive acid blocker (P‑CAB) for gastrointestinal diseases in Mainland China.
Deal Structure & Responsibilities
| Item | Detail |
|---|---|
| Partners | Huadong Medicine (commercialization) / Sinorda (MAH) |
| Territory | Mainland China (exclusive) |
| Product | Linaprazan glurate capsules |
| Indication | Erosive esophagitis (reflux esophagitis) and other GI acid‑related disorders |
| Deal Type | Exclusive commercialization agreement |
| Financial Terms | Upfront payment + undisclosed milestone payments (specifics not disclosed) |
| Approval Status | Approved in China; included in 2025 National Reimbursement Drug List (NRDL) |
Drug Profile & Strategic Positioning
- Mechanism: Next‑generation Potassium‑Competitive Acid Blocker (P‑CAB) that provides rapid, potent, and durable gastric acid suppression compared to traditional proton‑pump inhibitors (PPIs).
- Innovation: Co‑developed by Sinorda and Cinclus Pharma; Sinorda holds global IP and serves as Marketing Authorization Holder (MAH).
- Competitive Edge: Inclusion in the 2025 NRDL ensures reimbursement coverage, accelerating hospital listing and patient access across Tier‑1 to Tier‑3 cities.
- Clinical Value: Demonstrates faster onset of action and improved nighttime acid control, addressing unmet needs in severe reflux disease.
Market Impact & Outlook
- China GI Market: The domestic market for acid‑suppression therapies exceeds ¥8 billion (~US$1.1 billion) annually, with P‑CABs gaining share as hospitals seek alternatives to generic PPIs.
- Revenue Forecast: Huadong Medicine projects ¥300–400 million in first‑year sales (2026) for Linaprazan glurate, leveraging its 3,000‑person sales force and established relationships with 5,000+ hospitals.
- Strategic Synergy: This partnership strengthens Huadong’s gastroenterology portfolio, complementing its existing franchise in immunology and metabolic diseases.
- Next Steps: Huadong will initiate a nationwide marketing campaign in Q1 2026, targeting both gastroenterology KOLs and primary‑care physicians in high‑prevalence regions.
Forward‑Looking Statements
This brief includes forward‑looking statements regarding commercial expectations, revenue forecasts, and market penetration for Linaprazan glurate. Actual results may differ materially due to regulatory changes, competitive dynamics, and market adoption rates.-Fineline Info & Tech