Description
Indication & Scope
KaiLiMei contains satricabtagene autoleucel, an autologous humanized CLDN18.2-targeted CAR-T cell therapy for CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma with failure of at least two lines of prior systemic therapy.
- Mechanism: Genetically modified autologous T cells express chimeric antigen receptor targeting CLDN18.2; the engineered CAR-T cells specifically recognize and eliminate CLDN18.2-positive tumor cells to suppress tumor progression.
- Drug class: Autologous humanized Claudin 18.2-targeted CAR-T cell therapy
- Clinical use:Treatment of CLDN18.2-positive, HER2-negative advanced gastric cancer or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior systemic therapies.
| Generic Name | Satricabtagene autoleucel |
| Brand Name | Kailimei® |
| Ingredient | Autologous humanized CAR-T cells genetically modified to express a Claudin18.2 (CLDN18.2)-specific chimeric antigen receptor. |
| Dosage Form | Concentrate for Solution for Infusion |
| Package | Patient-specific autologous CAR-T cell infusion product. |
| Conditions Treated | Treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. |
| Taboos | Contraindicated in patients with hypersensitivity to satricabtagene autoleucel or any component of the product. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store according to the approved package labeling for cryopreserved CAR-T cell therapy products. |
| Manufacturer | Kaixing Life Technology (Shanghai) Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: Administer according to the approved treatment protocol. The dose is determined based on the patient-specific CAR-T cell product manufacturing process and clinical treatment requirements.
Time: Administer as a single intravenous infusion according to the approved treatment schedule after completion of lymphodepleting chemotherapy.
Instructions for use: Administer by intravenous infusion using the patient-specific autologous CAR-T cell infusion product. Confirm patient identity and product information before infusion. The product should be handled, thawed, and administered according to the approved instructions for use at a qualified medical institution. Monitor patients closely after infusion for potential adverse reactions.
Interaction: No clinically significant drug interactions have been identified. Concomitant immunosuppressive therapies may affect CAR-T cell activity and should be used according to clinical recommendations.
Side effects: Cytokine release syndrome (CRS), fever, fatigue, infections, cytopenias (including leukopenia, lymphopenia, anemia, and thrombocytopenia), and immune-related adverse reactions.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is Kailimei® (satricabtagene autoleucel)?
Kailimei is an autologous humanized CAR-T cell therapy product targeting Claudin18.2 (CLDN18.2). It uses genetically modified patient-derived T cells to recognize and eliminate CLDN18.2-expressing tumor cells.
What is the mechanism of action of Kailimei?
Kailimei expresses a CLDN18.2-specific chimeric antigen receptor (CAR) that recognizes CLDN18.2 on tumor cells, activates T-cell-mediated immune responses, and promotes tumor cell killing.
Is Kailimei a conventional chemotherapy or targeted drug?
No. Kailimei is a cellular immunotherapy product. Unlike conventional chemotherapy or small-molecule targeted therapies, it uses genetically modified immune cells from the patient to specifically attack tumor cells.
Why is CLDN18.2 testing required before treatment?
Kailimei targets CLDN18.2, so confirming CLDN18.2 expression in tumor tissue is necessary to identify patients who may benefit from treatment.
KaiLiMei® Satricabtagene Autoleucel | Gastric Cancer | DengYueRX
INN: Satricabtagene Autoleucel
Indications: CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after failure of at least two lines of systemic therapy
Dosage Form: Concentrate for Solution for Infusion
Strength: 2.5 × 10⁸ CAR-CLDN18.2-positive T cells/dose (8–25 mL/bag)
