Niraparib

Ovarian cancer is one of the malignant tumors with the highest mortality rate in the female reproductive system. 70% of patients are already at an advanced stage when first diagnosed, and the risk of postoperative recurrence remains high. There has been a long-term lack of effective maintenance treatment regimens in clinical practice. Niraparib is a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor. By blocking the DNA repair function of PARP enzymes, it exerts a "synthetic lethality" effect in tumor cells carrying BRCA gene mutations. It is the first PARP inhibitor approved in the world that can be used for maintenance treatment of all patients with platinum-sensitive recurrent ovarian cancer regardless of BRCA mutation status. At present, it has also been expanded to the later-line treatment of fallopian tube cancer and primary peritoneal cancer, greatly shortening the recurrence interval of patients and significantly prolonging the median survival time.

In recent years, the global market size of niraparib has been growing steadily, exceeding 1.8 billion US dollars in 2023. As its indications are included in the medical insurance catalogue in the Chinese market, its market size in China exceeded 1.8 billion yuan in 2023, with a compound annual growth rate of over 45% for three consecutive years. In terms of the competitive landscape, the original research product still accounts for about 60% of the market share. Three domestic enterprises have had their generic drugs approved for marketing, all of which are included in the seventh batch of national centralized drug procurement. The winning bid price is about 75% lower than that of the original research product. With the implementation of the centralized procurement, the market penetration rate of domestic generic drugs is increasing rapidly.

The original research enterprise of niraparib is Tesaro (later acquired by GlaxoSmithKline), and the original research trade name is "Zejula". Its core compound patent will expire in 2034 in China, and relevant patents such as crystal form and use patents will expire successively from 2030 to 2042. The main dosage form approved for the original research product is capsules, with a specification of 100mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and also listed in the FDA Reference Preparations Catalogue. At present, more than 10 enterprises in China have obtained CDE registration numbers for niraparib API, among which more than 5 have been registered in Status A. Multiple preparation varieties including the original research product and domestic generic drugs have been approved for marketing. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of niraparib impurity reference standards, covering all research dimensions such as process impurities and degradation impurities. Most of the products are available in stock. Spot 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 effectively support the full-process needs of API R&D, quality research and compliance declaration.