Fluzoparib

In response to the clinical treatment needs of homologous recombination repair deficiency-related malignant tumors such as recurrent or metastatic ovarian cancer and prostate cancer, PARP inhibitors block the DNA damage repair pathway of tumor cells in a targeted manner, achieving precise killing of tumor cells while reducing damage to normal tissues, and have become a popular research and development direction in the anti-tumor field in recent years. As a Class 1 innovative PARP inhibitor independently developed in China, fluzoparib can specifically inhibit the activity of PARP enzymes, hinder the repair of DNA single-strand damage in tumor cells, and ultimately induce tumor cell apoptosis through the synthetic lethal effect. It has been approved for the maintenance treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, as well as the treatment of patients with recurrent ovarian cancer who carry germline BRCA mutations and have received prior second-line or above chemotherapy, providing a medication option with both efficacy and economy for the relevant indication population.

In recent years, the domestic PARP inhibitor market size has continued to expand. In 2023, the overall market size has exceeded RMB 7 billion, with a compound annual growth rate remaining above 35%. Among them, fluzoparib, relying on its localized R&D advantages, achieved hospital sales of RMB 1.12 billion in 2023, accounting for approximately 16% of the domestic PARP inhibitor market. Currently, there are 6 PARP inhibitors approved for marketing in China, 3 of which are domestically developed varieties. Fluzoparib is the first domestically produced PARP inhibitor with fully independent and controllable core patents. As multiple indications have been included in the National Medical Insurance Catalog in recent years, the accessibility of medication for patients has been greatly improved, and its market share is still in a steady upward range.

The original research enterprise of fluzoparib is Jiangsu Hengrui Pharmaceutical Co., Ltd., with the trade name Aireyi. The expiration date of its core compound patent in China is November 2037. At present, the original research dosage form approved for marketing in China is capsule, with two specifications of 50mg and 100mg. This product has been included in the *Reference Preparation Catalog of Chemical Drugs* issued by the National Medical Products Administration. In terms of API registration, Hengrui Pharmaceutical's fluzoparib API has completed A-status registration at the Center for Drug Evaluation of the National Medical Products Administration and can be legally supplied for the production of associated preparations. Currently, no other domestic enterprises have obtained approval for the registration of fluzoparib API, and only the original research product has been approved for marketing among preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of fluzoparib impurity reference standards, covering all categories such as process impurities and degradation impurities. Most of the products are directly available in stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the API R&D, quality research and production quality control links of relevant pharmaceutical enterprises.