CSTONE PHARMA-B Initiates Nationwide Commercial Distribution of Locally Produced Pralsetinib Capsules

Stock News
05/11

CSTONE PHARMA-B (02616) has announced that the first batch of locally produced Pralsetinib Capsules (100mg), its highly selective RET inhibitor, has completed manufacturing and quality release, officially commencing nationwide commercial distribution. This marks a critical step towards domestic supply chain independence for this innovative drug. Pralsetinib Capsules were first included in the National Reimbursement Drug List (NRDL) at the end of 2025, with the listing taking effect from January 1, 2026. Benefiting from the significant improvement in patient accessibility due to the NRDL inclusion, terminal sales of Pralsetinib Capsules have grown rapidly, increasing by over 430% year-on-year as of April 2026. Based on this growth trajectory, full-year 2026 sales revenue for Pralsetinib Capsules is projected to potentially exceed RMB 300 million. Dr. Yang Jianxin, Chief Executive Officer, Head of R&D, and Executive Director of CSTONE PHARMA-B, stated, "The successful shipment of the first batch of locally produced Pralsetinib Capsules is the result of the strict adherence to international standards and efficient collaboration among our production, quality, regulatory, and supply chain teams. Through rigorous technology transfer and process validation, we have ensured that the locally produced products are highly comparable to the imported ones in terms of quality and efficacy. As the localized production and supply system matures, we will fully meet the clinical demand released following the implementation of the NRDL, effectively ensuring drug accessibility and supply stability. Simultaneously, full-chain localization will significantly optimize our cost structure, enhancing profitability resilience and commercial vitality. Looking ahead, CSTONE PHARMA-B will remain committed to its founding mission, ensuring a stable supply of high-quality medicines to benefit more patients in China."

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