Oxaliplatin

Colorectal cancer, a highly prevalent gastrointestinal malignant tumor worldwide, has long relied on the synergistic effect of platinum-based drugs in clinical chemotherapy regimens. Oxaliplatin is a third-generation platinum-based antitumor drug. It forms cross-links with the DNA strands of tumor cells, blocks DNA replication and transcription, and induces apoptosis. Its gastrointestinal toxicity and nephrotoxicity are significantly lower than those of previous generation products such as cisplatin and carboplatin. Currently, it is the core drug for first-line chemotherapy and postoperative adjuvant chemotherapy for metastatic colorectal cancer, and can also be used in combination regimens for the treatment of gastrointestinal tumors such as gastric cancer and pancreatic cancer, covering more than one million adult patients with solid tumors.

The global oxaliplatin market size was approximately USD 1.28 billion in 2023, with China accounting for more than 45% of the market, and the compound annual growth rate remaining at 3.2%. As the patent for the original research compound has long expired, the domestic generic drug market is highly competitive. At present, oxaliplatin preparations from more than 30 enterprises have passed the consistency evaluation. The maximum price reduction of the varieties included in the national centralized procurement catalog is more than 90% compared with the original research drug, which greatly improves the accessibility of drugs for primary-level patients, and the demand for upstream API is stable at about 150 tons per year.

The original research enterprise of oxaliplatin is Debiopharm of Switzerland, and the original trade name is Eloxatin. Its European compound patent expired in 2006, the US patent expired in 2007, and the Chinese compound patent expired in 2013. The main dosage form of the original research product is injection, with specifications of 50mg and 100mg, which have been included in the Chinese *Catalog of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalog. According to the domestic API registration platform, more than 20 enterprises have completed the A-status registration of oxaliplatin APIs at present. The preparation varieties approved for marketing include oxaliplatin for injection and oxaliplatin injection, covering all clinically common specifications. (Data as of November 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of oxaliplatin impurity reference standards, covering more than 20 kinds of key intermediate impurities and degradation impurities in the synthesis route. Most of the 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 relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can be directly used in API quality research, impurity quantitative analysis and registration declaration processes.