Zoledronic Acid

Bone metastasis is a common complication of advanced malignant tumors. About 70% of breast cancer and prostate cancer patients with bone metastasis will suffer from severe bone pain and hypercalcemia, which seriously reduces their quality of life. As a third-generation bisphosphonate drug, zoledronic acid specifically binds to hydroxyapatite in bone tissue, inhibits the activity of osteoclasts and induces their apoptosis, thereby reducing bone resorption and lowering the risk of skeletal-related events. It is widely used clinically to treat bone pain caused by osteolytic bone metastasis of malignant tumors and hypercalcemia complicated by malignant tumors, and can also be used for the treatment of osteoporosis in postmenopausal women, covering patient groups in multiple departments such as oncology, orthopedics and endocrinology.

The current global market size of zoledronic acid is approximately USD 1.2 billion, and the domestic market size is stable at around RMB 1.8 billion, with a compound annual growth rate of 4.2%. As the original research patent has long expired, the competition of domestic generic drugs is sufficient. At present, more than 30 enterprises have obtained preparation approvals, and 7 enterprises have obtained CDE approval for their active pharmaceutical ingredients (APIs). After the centralized procurement, the price of preparations has dropped by more than 90%, the clinical accessibility has been greatly improved, and the drug demand of primary medical institutions continues to be released, driving the stable demand for upstream APIs.

The original research enterprise of zoledronic acid is Novartis Pharma, with the original brand name "Zometa". Its core compound patent expired in 2013 in both Europe and the United States, and the Chinese patent also expired in 2014. The main dosage form approved for the original product is injection, with a specification of 4mg/vial, which has been included in the Reference Listed Drug Catalog of the China Listed Drug Collection, and is also included in the FDA Reference Preparation Catalog. In terms of domestic API registration, there are currently 22 relevant API registration numbers, of which 15 have been announced with A status. The domestically approved preparation varieties include zoledronic acid for injection, zoledronic acid injection, etc., covering multiple specifications such as 4mg and 5mg. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the needs of zoledronic acid quality research and consistency evaluation, CATO provides a full set of impurity reference standards for this API, which can cover the full-dimensional detection needs of process impurities and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the quality control needs of pharmaceutical enterprises in the process of R&D and production.