Cosela® (Chinese brand name: Kesaila®) is the commercial brand name of Trilaciclib Hydrochloride for Injection, a short-acting reversible CDK4/6 inhibitor jointly developed by G1 Therapeutics and Simcere Pharmaceutical. It blocks normal bone marrow hematopoietic progenitor cells at the G1 phase of the cell cycle prior to chemotherapy, shielding bone marrow cells from chemotherapy-induced injury to alleviate chemotherapy-related myelosuppression. It was first approved for marketing in the United States in February 2021, obtained conditional marketing approval in China in July 2022, and officially launched in the Chinese market in early 2023.
Main Indications
Prophylactic intravenous infusion before platinum-etoposide combined chemotherapy for adult patients with untreated extensive-stage small cell lung cancer (ES-SCLC), to reduce the incidence of chemotherapy-induced myelosuppression.
Clinical Research
Global multicenter phase III pivotal trials demonstrated that trilaciclib significantly shortened the duration of grade 4 severe neutropenia in the first cycle of chemotherapy, reduced the incidence of severe neutropenia, thrombocytopenia and anemia, cut down the usage of granulocyte-stimulating factors and blood transfusion support, and did not interfere with the anti-tumor efficacy of chemotherapy for extensive-stage small cell lung cancer;
Registration clinical trials enrolling Chinese ES-SCLC patients confirmed rapid bone marrow protective effect, with efficacy and safety data consistent with global research populations;
Long-term follow-up trials proved continuous bone marrow protection throughout multi-cycle chemotherapy, with no cumulative bone marrow toxicity, and the drug has been awarded Grade 2A recommendation in CSCO Small Cell Lung Cancer Guidelines and included in NCCN Small Cell Lung Cancer Guidelines for chemotherapy myeloprotection.
Common Side Effects
Severe adverse reactions: Severe infusion hypersensitivity, respiratory failure, cerebral hemorrhage, venous thromboembolism;
Common mild adverse reactions: Transaminase elevation, headache, rash, peripheral edema, abdominal pain, hyperglycemia, fatigue.
Approval Status in China
Cosela® (Trilaciclib Hydrochloride for Injection, specification: 300mg per vial, conditional approval product) was approved for marketing in China for myeloprotection during first-line chemotherapy for adult extensive-stage small cell lung cancer, bringing a proactive bone marrow protection medication choice for domestic lung cancer patients receiving chemotherapy.
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