Nedaplatin

As one of the core varieties of the second-generation platinum antitumor drugs, nedaplatin binds to the DNA of tumor cells and forms cross-links to block DNA replication, thereby inhibiting the proliferation of tumor cells. Its nephrotoxicity and gastrointestinal adverse reactions are significantly lower than those of cisplatin, and there is no complete cross-resistance between nedaplatin and cisplatin. Clinically, it is mainly used for the treatment of solid tumors such as head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophageal cancer and ovarian cancer, and is applicable to patients with solid tumors who cannot tolerate the adverse reactions of cisplatin or develop drug resistance after cisplatin treatment, making it an important option in clinical platinum-based combination chemotherapy regimens.

The global nedaplatin market size was approximately USD 320 million in 2023, with the Chinese market accounting for more than 60%, and the compound annual growth rate in the past five years reached 7.8%. The main driving factors for the growth are the rising incidence of indications such as head and neck cancer and lung cancer, as well as the increasing penetration rate of nedaplatin in chemotherapy regimens for elderly and frail patients. In terms of competitive landscape, the domestic preparation market is dominated by generic drugs, with a total of 13 enterprises holding marketing approvals for nedaplatin injections. In the seventh batch of nationally organized drug centralized procurement in 2022, the average price reduction of winning bids for nedaplatin injections reached 62%, which further promoted the improvement of clinical accessibility.

The original developer of nedaplatin is Shionogi & Co., Ltd. of Japan, with the brand name "Lubei" (Aqupla). The expiration time of its core compound patent in major markets such as Japan and the United States is 2005, and the expiration time of the compound patent in China is 2004. The main dosage form approved for the original drug is injection, with specifications of 10 mg/vial and 50 mg/vial. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also listed as a reference preparation by the FDA. In terms of domestic API registration, as of now, nedaplatin APIs from 8 enterprises have completed registration at the Center for Drug Evaluation (CDE) and are in Status A, and all the preparation varieties approved for marketing are nedaplatin for injection. (Data as of August 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for nedaplatin API, covering all types such as process impurities and degradation impurities. 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 meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in drug development, quality research, stability study, etc.