Rucaparib

In the clinical pathway of PARP inhibitor targeted therapy for advanced ovarian cancer, rucaparib is one of the core drugs with both maintenance therapy and later-line therapy values. As a poly adenosine diphosphate ribose polymerase (PARP) inhibitor, it can exert a synthetic lethal effect on tumor cells carrying BRCA gene mutations by blocking the DNA repair function of PARP enzymes. Currently, it has been approved for the maintenance treatment of BRCA mutation-positive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, as well as the monotherapy for patients with BRCA-mutated advanced ovarian cancer who have received prior second-line or above chemotherapy, providing patients with relapsed and refractory gynecologic tumors a longer progression-free survival option.

The global market size of rucaparib exceeded USD 180 million in 2022, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 7.2%. The growth drivers mainly come from the increase in the penetration rate of targeted therapy for ovarian cancer and the popularization of BRCA testing. In terms of the competitive landscape, the current global market is still dominated by the original research product, and generic manufacturers are still in the clinical declaration stage. There is no generic drug approved for marketing in China yet. As the window for core patent expiration approaches, the demand for the layout of API and generic drugs continues to rise.

The original research enterprise of rucaparib is Clovis Oncology, and the original research trade name is Rubraca. Its core compound patent has expired in the European region in 2027, and the core patent in the US region will expire in 2030. The main dosage form approved for the original research product is tablet, with three specifications including 200mg, 250mg and 300mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, there is no rucaparib preparation approved for marketing within China, and no valid rucaparib API registration number has been found on the CDE API registration platform. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of rucaparib, CATO can provide a full set of impurity reference standards for this API. 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 provide stable and reliable reference standard support for pharmaceutical enterprises' process development, quality research and declaration work.