Vinorelbine

As a classic cytotoxic anti-tumor drug, vinorelbine belongs to semi-synthetic vinca alkaloids, and exerts anti-tumor activity by inhibiting tubulin polymerization and arresting cell mitosis in the G2/M phase. Clinically, it is mainly used for the treatment of non-small cell lung cancer, metastatic breast cancer, ovarian cancer and malignant lymphoma. It is a core component of the first-line chemotherapy regimen for advanced non-small cell lung cancer, and also a common choice in the palliative treatment stage of breast cancer, meeting the multi-line treatment needs of adult patients with solid tumors.

At present, the global market size of vinorelbine is approximately RMB 1.4 billion, with the Chinese market accounting for more than 45%, and the compound annual growth rate in the past three years has maintained at around 4.2%. The growth momentum mainly comes from the improvement of the coverage of primary tumor diagnosis and treatment and the continuous increase in the number of new patients with breast cancer and lung cancer. In terms of the competitive landscape, domestic generic drug companies have occupied nearly 70% of the market share. Among them, the oral dosage form has achieved a sales growth rate 2.3 times that of the injection in recent years due to its advantage of patient compliance, and has been included in the provincial centralized procurement scopes of multiple provinces. The winning bid price is approximately 62% lower than that of the original drug, further promoting the improvement of clinical accessibility.

The original developer of vinorelbine is Pierre Fabre of France, and the original trade name is "Navelbine". The core compound patents of the original drug expired in 2003 and 2004 in the United States and Europe respectively, and the compound patent in China expired in 2002. At present, the dosage forms of the original drug approved in China include injection (10mg/1ml, 50mg/5ml) and soft capsule (20mg, 30mg). Relevant dosage forms have all been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and have also been收录 as reference preparations by the FDA. Up to now, there are 19 pieces of vinorelbine API registration information on the API Registration Platform of China CDE, among which 11 are in the status of "A (approved for use in marketed preparations)". In China, vinorelbine for injection from 27 enterprises and vinorelbine soft capsules from 12 enterprises have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for vinorelbine API, covering the research needs of the whole path including starting materials, intermediates 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 Chinese Pharmacopoeia and FDA, and can directly support the API registration and declaration as well as quality research work.