Cisplatin

As a classic cytotoxic anti-tumor drug, cisplatin forms cross-links with the DNA strands of tumor cells, inhibits DNA replication and transcription processes, and induces apoptosis of tumor cells, serving as a basic medication for the treatment of multiple solid tumors. Its indications cover a number of high-incidence tumor types such as non-small cell lung cancer, testicular cancer, ovarian cancer, bladder cancer, and head and neck squamous cell carcinoma. It can be used as a single agent or combined with chemotherapy, targeted therapy, and immunotherapy to form synergistic regimens, and is an indispensable cornerstone drug in clinical tumor treatment. The applicable population covers solid tumor patients of all ages who meet the treatment indications, and it is also used as a core drug in the treatment of some pediatric germ cell tumors.

At present, the global cisplatin market size maintains a steady growth trend. In 2023, the global market size was approximately USD 280 million, with a compound annual growth rate maintained at around 3.2%. The growth momentum mainly comes from the rising incidence of tumors in emerging markets and the popularization of combination therapy regimens. In terms of the domestic market, cisplatin is a Class A variety under the national medical insurance, and has been included in multiple batches of the national centralized procurement catalog. After the centralized procurement, the price has dropped by more than 80%, and the clinical accessibility has been greatly improved. The competitive landscape is dominated by generic drugs. There are more than 15 domestic API manufacturers, with Jiangsu, Shandong, and Zhejiang as the core main production areas. The production capacity of leading enterprises accounts for more than 60%, and the overall supply is stable. Short-term supply fluctuations may occur only in some periods due to environmental protection inspections.

The original research enterprise of cisplatin is Bristol-Myers Squibb (USA), with the original brand name Platinol. The core compound patent expired globally in 1985, and there is no subsequent extension of core patents. The main dosage forms approved for the original product include injections, with two specifications of 10mg/20ml and 50mg/50ml. The product has been included in the FDA Orange Book Reference Listed Drug Catalog, and China's *Catalog of Reference Listed Drugs for Chemical Products* also includes this original product as a reference listed drug. In terms of domestic API registration, 23 enterprises have completed the registration of cisplatin APIs with the CDE, all with the status of "A (already used in marketed preparations)". There are more than 80 varieties of cisplatin injections, cisplatin for injection and other preparations approved for marketing in China, with sufficient supply. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for cisplatin API, covering all research dimensions such as synthetic process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support the full-process R&D and production quality control needs such as API registration and declaration, quality research, and stability study, so as to reduce R&D compliance risks and shorten the project promotion cycle.