Description
Indication & Scope
SaiTanXin® Culmerciclib Capsules provides combination therapy with fulvestrant for adult patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer progressing after prior endocrine treatment.
- Mechanism: First-in-class triple cyclin-dependent kinase inhibitor targeting CDK2, CDK4 and CDK6 simultaneously. It blocks cyclin-CDK complex formation, arrests cancer cell cycle at G1 phase, suppresses HR-positive breast tumor proliferation and overcomes drug resistance against selective CDK4/6 single-target inhibitors.
- Drug class: Oral triple CDK2/4/6 small-molecule inhibitor / Targeted anti-breast cancer therapy.
- Clinical use: Second-line combination targeted therapy with fulvestrant for HR+/HER2- metastatic breast cancer post-endocrine failure; lower myelosuppression toxicity profile versus older CDK4/6 selective inhibitors.
| Generic Name | Culmerciclib Capsules |
| Brand Name | SaiTanXin |
| Ingredient | Culmerciclib |
| Dosage Form | Capsules |
| Package | 50mg(quantity to be determined);
60mg*28 capsules/box |
| Conditions Treated | HR-positive, HER2-negative locally advanced or metastatic breast adenocarcinoma |
| Taboos | Severe hypersensitivity to culmerciclib or capsule excipients; patients with grade 4 baseline neutropenia or thrombocytopenia; pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed blister capsules stored at controlled room temperature between 15°C and 30°C, moisture-proof packaging |
| Manufacturer | CHIATAI TIANQING Pharmaceutical Group Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250068; H20250069 |
| Approval Date | Dec 9, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard dose 120 mg oral once daily continuously, combined with standard fulvestrant intramuscular injection schedule.
Time: Single daily oral capsule taken at fixed consistent time, with food intake to reduce gastrointestinal irritation.
Instructions for use: Swallow capsule whole with water without breaking open; pause dosing for grade ≥3 neutropenia until blood cell count recovers; monitor complete blood count every 2 cycles to track hematologic toxicity.
Interaction: Strong CYP3A4 inhibitors elevate culmerciclib plasma concentration and blood cell toxicity risk; strong CYP3A4 inducers reduce anti-tumor efficacy significantly.
Side effects:
1. Common manageable adverse events: mild neutropenia, fatigue, nausea, diarrhea, elevated blood creatine kinase.
2. Severe grade 3+ risks: severe prolonged myelosuppression, interstitial lung disease, severe hepatic enzyme elevation.
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, indicatiaon, 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 three cyclin-dependent kinases does Culmerciclib Capsules simultaneously inhibit?
It inhibits CDK2, CDK4 and CDK6 triple kinase targets.
What endocrine drug must Culmerciclib Capsules be combined with for breast cancer treatment?
It is used in combination with fulvestrant intramuscular injection therapy.
What core clinical advantage does Culmerciclib Capsules triple CDK inhibitor have over single-target CDK4/6 agents?
It overcomes tumor resistance to selective CDK4/6 inhibitors with reduced severe myelosuppression.
What routine lab test needs regular monitoring during each treatment cycle when using Culmerciclib Capsules?
Complete blood count to track neutrophil and platelet hematologic toxicity.
SaiTanXin® | Culmerciclib Capsules | Breast Cancer | DengYueRX
INN: Culmerciclib Capsules
Indications: Breast cancer
Dosage Form: Capsules
Strength: 50mg/capsule; 60mg/capsule
