Pazopanib

Advanced renal cell carcinoma is a highly prevalent malignant tumor of the urinary system. Most patients have already progressed to the advanced stage at the time of diagnosis, and the response rate of traditional chemotherapy is less than 10%, leaving the clinical practice in a long-term dilemma of limited treatment options. Pazopanib is a multi-target tyrosine kinase inhibitor, which can block tumor angiogenesis and cell proliferation by targeting and inhibiting signaling pathways such as VEGFR, PDGFR and c-Kit. Currently, its approved indications include advanced renal cell carcinoma and advanced soft tissue sarcoma that has received prior chemotherapy. Meanwhile, it has also shown clinical potential in the exploration of second-line treatment for ovarian cancer and non-small cell lung cancer, and is one of the core options for targeted therapy in patients with advanced solid tumors.

At present, the global pazopanib market size is stable at around USD 1.2 billion, affected by the launch of generics, the growth rate has maintained at around 1.8% in recent years. In the Chinese market, with the increasing incidence of renal cell carcinoma year by year and the coverage of medical insurance reimbursement, the overall market size exceeded RMB 1.5 billion in 2023, with generics accounting for more than 60%. In terms of the competitive landscape, 7 domestic enterprises have been approved for pazopanib generic preparations. In addition to the original manufacturer, 11 domestic pharmaceutical companies have completed CDE registration of pazopanib API, including 8 A-status registration numbers, with sufficient market supply. The winning bid price in centralized procurement has decreased by more than 90% compared with the initial price of the original drug when it was launched, and the accessibility of medication for patients has been greatly improved.

The original developer of pazopanib is GlaxoSmithKline, with the original brand name "Votrient". Its compound patent in China expired in 2021, the core European patent expired in 2020, and the US patent expired in 2022. The approved dosage form of the original drug is tablet, with specifications of 200mg and 400mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation recognized by the FDA. Domestically, there are currently 11 CDE registration numbers for pazopanib API, 8 of which are in A status; pazopanib tablets from 7 enterprises have been approved for marketing, all of which have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for pazopanib API, fully covering synthetic process impurities and degradation impurities. Most products are regularly kept in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for API and preparation enterprises in links such as quality research, stability study, registration and declaration.