By Fineline Cube 
CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib tablets, 100mg) in China, marking the official commencement of national commercial distribution for the RET inhibitor.
Strategic Partnership & Licensing Timeline
| Milestone | Date | Details |
|---|---|---|
| Licensing Agreement | June 2018 | CStone acquired Greater China rights from Blueprint Medicines (NASDAQ: BPMC) |
| Chinese Regulatory Approval | 2021 | NMPA approval for RET-altered cancers |
| Commercialization Partnership | November 2023 | Rights transferred to Allist Pharmaceuticals Co., Ltd |
| NRDL Inclusion | 2025 | Added to National Reimbursement Drug List |
| Commercial Launch | May 2026 | First manufactured batch released nationally |
Drug Profile & Market Position
Product Overview
- Generic Name: Pralsetinib
- Brand: Gavreto
- Dosage: 100mg tablets
- Mechanism: Selective RET inhibitor for daily oral administration
- Indication: RET-altered non-small cell lung cancer (NSCLC) and thyroid cancers
Commercial Strategy
The transition from CStone’s development phase to Allist Pharmaceuticals’ commercialization represents a strategic partnership model increasingly common in China’s biopharmaceutical landscape. With NRDL inclusion secured in 2025, Gavreto now benefits from enhanced patient access through national insurance coverage, positioning it competitively against other targeted therapies in the oncology segment.
Market Impact & Revenue Outlook
- Reimbursement Advantage: NRDL inclusion significantly reduces out-of-pocket costs for Chinese patients, potentially expanding market penetration beyond premium private-pay segments
- Competitive Landscape: Gavreto competes with other RET inhibitors including selpercatinib (Retevmo), though pricing advantages from NRDL status may provide market share opportunities
- Revenue Expectations: Industry analysts project moderate revenue growth for Allist Pharmaceuticals in 2026-2027, with Gavreto contributing an estimated ¥300-500 million annually depending on adoption rates across tier-1 and tier-2 hospitals
The successful manufacturing scale-up demonstrates CStone’s operational capabilities while allowing the company to focus on its core pipeline development, including ongoing clinical trials for additional indications and combination therapies.
Forward-Looking Statements
This brief contains forward-looking statements regarding commercial performance, market adoption, and revenue projections for Gavreto in China. Actual results may differ due to competitive dynamics, hospital formulary decisions, and evolving reimbursement policies.-Fineline Info & Tech