卡匹色替

In the clinical treatment of HR-positive/HER2-negative advanced breast cancer worldwide, endocrine therapy resistance has always been the core obstacle to prolonging the survival of patients. The advent of CDK4/6 inhibitors has broken this treatment bottleneck. As a new generation of oral selective CDK4/6 inhibitor, trilaciclib specifically blocks the transition of the cell cycle from G1 phase to S phase, thereby inhibiting the abnormal proliferation of tumor cells. Compared with traditional drugs of the same class, it exhibits better anti-tumor activity in previously treated and drug-resistant populations. The currently approved indication is for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy. Meanwhile, research on its combination therapy for other solid tumors is also in the clinical advancement stage.

The global market size of CDK4/6 inhibitors has exceeded 9 billion US dollars. Among them, the new generation of products has a compound annual growth rate of more than 22% due to the continuous release of treatment demand after drug resistance. At present, trilaciclib is in the early stage of global market promotion. No similar new-generation CDK4/6 inhibitor has been launched in China, and there are fewer than 10 enterprises under research, so the market competition pattern is relatively relaxed. With the further increase in the penetration rate of targeted therapy for breast cancer in the future, the market space of this product is expected to exceed 3 billion yuan.

The original research enterprise of trilaciclib is G1 Therapeutics in the United States, and the original research trade name is Cosela. Its core compound patent in the United States will expire in 2036, and the compound patent in China will expire in 2037. The main dosage form approved by the original research is tablet, with specifications including 50mg, 100mg and 150mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, China has not approved the marketing of the original research trilaciclib preparation, no enterprise has submitted the API registration information of trilaciclib on the CDE API registration platform for the time being, and the relevant generic drug research and development in China is all in the pre-clinical stage. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for trilaciclib, covering all key intermediates and degradation impurities in the synthesis route. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. For most products in stock, orders placed before 16:00 can be shipped on the same day, which can fully meet the rapid supply demand in the research and development stage, and provide stable reference standard support for the process development and quality research of relevant pharmaceutical enterprises.