Trilaciclib

Chemotherapy-induced myelosuppression is a common dose-limiting toxicity in clinical tumor treatment. In the past, management mostly relied on symptomatic intervention after the occurrence of adverse reactions, and there was a lack of proactive protection regimens. Trilaciclib is a highly selective and reversible cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Its core mechanism of action is to transiently block the cell cycle progression of bone marrow hematopoietic stem and progenitor cells, so that normal cells can avoid the killing effect of chemotherapeutic drugs, without affecting the sensitivity of tumor cells in a state of cycle失控 to chemotherapy. Currently, this drug is approved for administration to patients with extensive-stage small cell lung cancer before they receive chemotherapy regimens containing platinum/etoposide or topotecan. It can simultaneously reduce the incidence of neutropenia, anemia and thrombocytopenia, decrease the use of supportive treatments such as growth factors and blood transfusion, and improve the treatment tolerance of patients.

At present, the global market of bone marrow protective anti-tumor adjuvant drugs is in a stage of rapid expansion. In 2023, the market size has exceeded 1.8 billion US dollars, with a compound annual growth rate remaining above 22%. As the world's first and currently only approved bone marrow protective drug for pre-chemotherapy use, trilaciclib has achieved a rapid market penetration rate since its launch, and its clinical utilization rate in the field of small cell lung cancer treatment has exceeded 15%. At present, the relevant preparations of trilaciclib in the Chinese market are still mainly supplied by the original research manufacturer. Only 3 domestic pharmaceutical companies have submitted marketing applications for generic drugs, and no large-scale generic production capacity has entered the API supply side, so the market supply pattern is relatively concentrated.

The original research enterprise of trilaciclib is G1 Therapeutics in the United States, and the original research trade name is Cosela. The core compound patent expires in 2037 in the United States and in 2038 in China. The main dosage form approved by the original research is injection, with a specification of 300mg per vial. It has been included in the FDA Reference Listed Drug Catalog, and also included in the Chinese *Catalog of Chemical Drugs*. Currently, there is no registered A-number registration information for trilaciclib API in China, and only the original research imported trilaciclib for injection has been approved for marketing by the NMPA. (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 trilaciclib. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs in different stages such as API R&D, quality research and consistency evaluation.