Hong Kong-listed CStone Pharmaceuticals (CStone) has shipped the first domestically manufactured batch of 100 mg pralsetinib capsules, marking the start of nationwide commercial supply in mainland China.

The localized production completes the technical transfer from imported sources, with CStone stating that quality and efficacy are “highly comparable” to the original formulation. A domestic supply chain is expected to reduce costs and bolster gross-margin resilience while ensuring stable availability.

Commercial momentum has accelerated since pralsetinib was added to China’s National Reimbursement Drug List (NRDL) in late 2025, becoming reimbursable from 1 January 2026. As of April 2026, in-market sales volume had climbed more than 430 % year on year. Based on this trajectory, CStone forecasts full-year 2026 revenue from pralsetinib to exceed RMB 0.30 billion.

Pralsetinib is approved by China’s National Medical Products Administration for first-line and previously treated adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as well as RET fusion-positive thyroid cancer. Marketing authorisations have also been secured in Hong Kong and Taiwan, and the therapy—branded as GAVRETO®—is approved in the United States.

The molecule was discovered by Blueprint Medicines, which was acquired by Sanofi in July 2025. CStone holds exclusive rights for Greater China and, since November 2023, has partnered with Shanghai Allist Pharmaceuticals for mainland commercialisation.

Founded in 2015, CStone has launched four innovative drugs, secured 21 new-drug approvals across nine indications, and maintains a pipeline of 16 assets spanning ADCs, multispecific antibodies, immunotherapies and precision medicines.