Carboplatin

For the clinical treatment of malignant tumors such as epithelial ovarian cancer and small cell lung cancer, platinum-based chemotherapeutic drugs have always been one of the cornerstone regimens. As a second-generation platinum-based antitumor drug, carboplatin forms cross-links with the DNA strands of tumor cells, inhibits DNA replication and transcription, and induces apoptosis. Compared with the first-generation cisplatin, its nephrotoxicity and gastrointestinal adverse reactions are significantly reduced, providing a safer treatment option for elderly patients who cannot tolerate cisplatin and patients with underlying abnormal renal function. At present, it is widely used clinically in the first-line and subsequent treatment of a variety of solid tumors such as ovarian cancer, lung cancer, squamous cell carcinoma of the head and neck, and testicular cancer.

In recent years, the global market size of carboplatin preparations has stabilized at around USD 1.2 billion, and the annual growth rate of the Chinese market has maintained at 4.2%, among which public medical institution terminals account for more than 90%. This product has been included in the national centralized drug procurement. The average price reduction of the winning preparations in the fifth batch of centralized procurement reached 62%. With the improvement of the accessibility of primary-level medication, the demand for active pharmaceutical ingredients (APIs) continues to increase. At present, the domestic supply of carboplatin APIs is dominated by local enterprises, and the generic drug substitution rate has exceeded 95%. Only a small amount of original research APIs are imported for high-end special dosage forms.

The original research enterprise of carboplatin is Bristol-Myers Squibb, and the original research trade name is Paraplatin®. The core compound patent in the United States expired in 1996, and the Chinese compound patent expired in the same period. The dosage form approved by the original research is injection, with specifications including 50mg, 150mg and 450mg, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. According to the domestic API registration platform, currently 21 enterprises' carboplatin APIs have obtained Class A status through CDE registration, which can support the associated review for the marketing of domestic preparations. The number of domestic approved manufacturers of carboplatin injection has exceeded 30. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of carboplatin impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the needs of various stages of API R&D, quality research and registration declaration.