Platinib (Pujihua) is currently supplied by several manufacturers around the world.

Pralsetinib (trade name GAVRETO®) is an oral RET kinase inhibitor, first developed by Blueprint Medicines in the United States. It is used to treat RET fusion-positive non-small cell lung cancer and RET Mutation or fusion-related thyroid cancer. The drug received accelerated approval from the US FDA in September 2020. Blueprint As the original manufacturer, it is not only responsible for the clinical development of the drug, but also masters global patents and core production processes, and is the core supply source of Platinib.

Platinib has cooperated with Roche/Genentech in the early stage, and Roche is responsible for the global market except Greater China and the United States. But in 2023 Blueprint took back global commercialization rights except China. Currently in the US market, Blueprint mainly cooperates with Catalent , which is responsible for the production and commercial supply of drugs, while Rigel Pharmaceuticals Obtained commercial sales rights in the U.S. market starting in 2024 to help promote the clinical and commercialization of the drug in the United States.

In China, interests in Greater China are held by CStone Pharmaceuticals CStone Pharmaceuticals. CStone Started to introduce and promote the registration and commercialization of Platinib in China in 2020, and in 20244 The application for localized production was accepted by the State Food and Drug Administration in March, and was subsequently officially approved to carry out the full-process localized production of platinib from raw materials to preparations in July 2025. This means that China’s market supply will gradually get rid of its dependence on imports. It is expected that starting from 2026 CStone will become the main manufacturer of Platinib in Greater China.

To sum up, there are currently about four major manufacturers/partners involved in the production and supply of platinib globally:Blueprint Medicines (original research and development and global rights), Catalent (commercial production in the United States), Rigel Pharmaceuticals (the connection between sales and supply in the US market), CStone Pharmaceuticals (localized production in Greater China). From R&D to production to regional supply, these manufacturers form the core strength of Platinib's global supply chain.

Reference link:https://www.drugs.com

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