Talazoparib

In response to the treatment needs of BRCA mutation-related tumors, PARP inhibitors have been a research hotspot in the field of targeted therapy in recent years. As a third-generation highly selective PARP inhibitor, talazoparib inhibits PARP enzyme activity and captures PARP-DNA complexes simultaneously through a dual mechanism of action, blocks the DNA damage repair pathway of tumor cells, and induces a synthetic lethal effect. Currently, this drug has been approved for patients with germline BRCA mutations that are deleterious or suspected to be deleterious, HER2-negative locally advanced or metastatic breast cancer, and can also be used for later-line treatment of homologous recombination repair deficiency-related prostate cancer and ovarian cancer, providing more efficient treatment options for solid tumor patients carrying specific gene mutations.

The global market size of talazoparib was approximately USD 420 million in 2023. Driven by the increasing penetration rate of targeted therapy for breast cancer and prostate cancer, the compound annual growth rate from 2025 to 2030 is expected to remain at around 12%. The domestic market is still in the stage of exclusive occupancy by the original research drug at present. With the advancement of generic drug R&D by local pharmaceutical companies and the improvement of the popularity of BRCA gene testing, there is a large room for subsequent market expansion. There is no publicly verifiable data on the domestic market size by segment.

The original research enterprise of talazoparib is Pfizer Inc., and the original research trade name is "Talzenna". Its core compound patent will expire in 2027 in the United States, and the compound patent in China will expire in 2028. The main dosage form approved for the original research drug is capsules, with specifications including 0.25mg and 1mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (39th Batch)*. As of the time of retrieval, there is no generic talazoparib preparation approved for marketing in China. More than 10 enterprises have submitted API DMF registration applications, most of which are in the review and approval stage, and no domestic API with A-status registration number has been found. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for talazoparib API. The R&D process strictly meets the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. The impurity structure, purity, qualitative and quantitative data have all been fully verified, which can directly support the R&D and declaration of generic drugs, quality research and daily quality control testing needs. Most products are supplied from stock. Stock orders placed before 16:00 can be shipped on the same day, which can effectively shorten the R&D cycle and ensure the research progress.