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CStone’s AYVAKIT Wins China NMPA Approval
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CStone’s AYVAKIT Wins China NMPA Approval

CStone Pharmaceuticals (HK:2616) has released an update.

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CStone Pharmaceuticals has received approval from China’s National Medical Products Administration (NMPA) for the manufacturing localization registration application of AYVAKIT (avapritinib tablets) at both 100 mg and 300 mg strengths, aiming to replace imported products with domestic supply by late 2024 or early 2025. The approval marks a significant step in increasing treatment options for patients with gastrointestinal stromal tumors (GIST) in China and enhances the drug’s market competitiveness. Moreover, CStone is also progressing with the review process for GAVRETO (pralsetinib capsules), underlining its commitment to delivering quality precision medicines in the region.

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