Olaparib

For the targeted therapy of BRCA gene mutation-related tumors, PARP inhibitors represent a breakthrough progress in the clinical field over the past decade, and olaparib is the world's first approved PARP inhibitor for marketing. Its mechanism of action is to inhibit the activity of PARP enzymes, block the DNA single-strand damage repair pathway, and trigger a "synthetic lethality" effect in BRCA-mutated tumor cells, which accurately kills tumor cells while greatly reducing damage to normal tissues. At present, this drug has been approved for first-line maintenance treatment and later-line treatment of multiple tumor types such as ovarian cancer, breast cancer, pancreatic cancer and prostate cancer, covering adult patients carrying BRCA mutations or homologous recombination repair deficiency, significantly prolonging the progression-free survival of patients and reducing the risk of disease progression.

According to public data, the global market size of olaparib in 2023 was approximately USD 2.8 billion. Although its growth rate has slowed down due to patent expiration, with the further expansion of indications in fields such as prostate cancer, it is expected to maintain a compound annual growth rate of around 3% from 2025 to 2030. For the domestic market, the sales of olaparib at public hospital terminals exceeded RMB 2.2 billion in 2023. There are currently 8 domestic generic drugs approved for marketing, and olaparib has been included in the National Reimbursement Drug List (Category B). The out-of-pocket proportion for patients has decreased by more than 70% compared with the initial marketing period, and the market penetration rate is continuously increasing.

The original developer of olaparib is AstraZeneca, and the original brand name is "Lynparza". Its core compound patent in the United States expires in October 2024, and the core compound patent in China expired in 2023. The main dosage forms of the original marketed product include tablets, with two specifications of 100 mg and 150 mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. At present, there are more than 20 domestic marketing authorization application (MAA) numbers for olaparib active pharmaceutical ingredients (APIs), among which more than 10 are in status A (approved for use in marketed preparations), and 8 domestic preparation products have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for olaparib API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the reference standard use needs of pharmaceutical enterprises in the whole process from process research and development to registration and declaration.