Jiatailai® is the commercial brand name of Sacituzumab Tirumotecan for Injection, a Trop-2 targeted antibody-drug conjugate (ADC) independently developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. It specifically binds to Trop-2 antigen highly overexpressed on solid tumor cell membrane via humanized anti-Trop2 monoclonal antibody, undergoes intracellular endocytosis in tumor cells, releases topoisomerase I inhibitor payload KL610023 to break tumor DNA, induce cell cycle arrest and tumor cell apoptosis to exert potent anti-tumor activity. This product is only administered by intravenous infusion, with domestic class 1 new drug approval in China.
Main Indications
Adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior systemic therapies (at least one regimen for advanced/metastatic disease);
Adult patients with locally advanced or metastatic EGFR-mutant non-squamous non-small cell lung cancer with disease progression after EGFR-TKI treatment and platinum-based chemotherapy;
Adult patients with unresectable or metastatic HR-positive/HER2-negative breast cancer progressing after endocrine therapy and ≥1 prior chemotherapy for advanced disease;
Patients with locally advanced or metastatic urothelial carcinoma with disease progression after platinum-containing chemotherapy.
Clinical Research
Global and China-led multicenter Phase III pivotal trials confirmed sacituzumab tirumotecan achieved statistically significant overall survival (OS) and progression-free survival (PFS) benefits versus conventional chemotherapy for triple-negative breast cancer and EGFR-mutant NSCLC, delivering durable tumor regression and objective tumor remission;
The landmark Phase III OptiTROP-Lung05 trial published in The Lancet verified prominent long-term survival improvement for EGFR-TKI resistant lung cancer patients, with consistent efficacy in brain metastasis, liver metastasis and other clinical subgroups;
Registration clinical trials enrolling Chinese patients demonstrated anti-tumor efficacy and safety profiles consistent with global multi-center study data, accompanied by low severe adverse event incidence and low treatment discontinuation rate caused by toxic reaction;
Global Phase III TroFuse-005 clinical trial validated significant OS and PFS benefits for recurrent advanced endometrial cancer, supporting further new indication registration for gynecologic tumors.
Common Side Effects
Serious adverse reactions: Grade ≥3 neutropenia, febrile neutropenia, severe ocular surface disorders, severe oral mucositis;
Common mild-to-moderate adverse reactions: leukopenia, anemia, oral mucositis, ocular irritation, nausea, vomiting, fatigue, alopecia, rash, decreased appetite, urinary tract infection, infusion-related fever and chills. Most adverse events can be controlled by symptomatic treatment, dose adjustment or temporary treatment interruption.
Approval Status in China
Jiatailai® (Sacituzumab Tirumotecan for Injection, specifications: 200mg per vial, 100mg per vial), a domestic innovative ADC drug, obtained the first marketing approval from NMPA on November 22, 2024 for third-line treatment of advanced triple-negative breast cancer. The EGFR-mutant NSCLC indication was approved on March 4, 2025, and the HR-positive/HER2-negative advanced breast cancer indication was approved in February 2026. It is a core domestic Trop-2 ADC for multi-solid tumor targeted therapy.
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