Description
Indication & Scope
SaiTanXin® (Culmerciclib) is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have progressed after prior endocrine therapy.
- Mechanism: Culmerciclib is an oral cyclin-dependent kinase (CDK) inhibitor that targets CDK2, CDK4, and CDK6. By inhibiting CDK-mediated cell cycle progression, it suppresses tumor cell proliferation.
- Drug Class: CDK2/4/6 inhibitor.
- Clinical Use: Treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following progression after endocrine therapy.
| Generic Name | Culmerciclib Capsules |
| Brand Name | SaiTanXin® |
| Ingredient | Culmerciclib |
| Dosage Form | Capsule |
| Package | 60 mg × 28 capsules/box |
| Conditions Treated | HR-positive, HER2-negative locally advanced or metastatic breast cancer |
| Taboos | Hypersensitivity to Culmerciclib or any component of the product |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store in a sealed container at 15–30°C, protected from light |
| Manufacturer | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250068 |
| Date of Revision | 2025 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: 180 mg administered orally once daily according to the approved prescribing information.
Time: Administer once daily with or without food. Swallow capsules whole and do not crush, split, or chew.
Instructions for use: Continue treatment until disease progression or unacceptable toxicity occurs. Dose interruption or dose reduction may be required for hematological toxicities such as neutropenia or thrombocytopenia. Patients with severe hepatic impairment may require dose adjustment.
Interaction: Strong CYP3A4 inhibitors may increase Culmerciclib exposure and require dose adjustment. CYP3A4 inducers may decrease drug exposure and reduce therapeutic efficacy.
Side effects: Common adverse reactions include neutropenia, leukopenia, anemia, fatigue, and nausea. Other reported adverse reactions include elevated liver enzymes, alopecia, and diarrhea.
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 precautions should be considered?
Regular blood count monitoring is recommended during treatment. Effective contraception should be used during treatment and for 6 months after the last dose.
What are the common side effects?
Common adverse reactions include neutropenia, leukopenia, anemia, fatigue, and nausea.
How should SaiTanXin® be taken?
SaiTanXin® is taken orally once daily with or without food. Capsules should be swallowed whole.
How does Culmerciclib work?
Culmerciclib inhibits CDK2, CDK4, and CDK6, preventing cancer cell cycle progression and reducing tumor cell proliferation.
SaiTanXin® | Culmerciclib | HR-Positive, HER2-Negative Advanced Breast Cancer | DengYueRX
INN: Culmerciclib
Indications: HR-positive, HER2-negative advanced breast cancer
Dosage Form: Capsule
Strength: 60 mg/Capsule
