Description
Indication & Scope
BaiYueDa® (Sonrotoclax) is a selective BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies, including a Bruton tyrosine kinase (BTK) inhibitor. The approval is conditional and subject to confirmation of clinical benefit through post-marketing studies.Sonrotoclax promotes apoptosis of malignant B cells by selectively inhibiting the anti-apoptotic BCL-2 protein.
- Mechanism: Sonrotoclax selectively binds to the BCL-2 protein, restoring apoptosis in malignant B cells and inhibiting tumor cell survival.
- Drug class: BCL-2 inhibitor.
- Clinical use: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior systemic therapies, including a BTK inhibitor.
| Generic Name | Sonrotoclax Tablets |
| Brand Name | BaiYueDa® |
| Ingredient | Sonrotoclax |
| Dosage Form | Tablet |
| Package | 1 mg / 5 mg / 20 mg / 80 mg per tablet |
| Conditions Treated | Relapsed or refractory mantle cell lymphoma (MCL) |
| Taboos | Hypersensitivity to Sonrotoclax or any component of the product |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store at 15–30°C in a dry place protected from light. |
| Manufacturer | BeiGene (Suzhou) Biotech Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250077 / H20250076 / H20250075 / H20250074 |
| Date of Revision | 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Treatment begins with a weekly dose-escalation schedule, followed by a maintenance dose of 320 mg once daily, according to the approved prescribing information.
Time: Administer orally once daily, with or without food.
Instructions for use: Swallow tablets whole without crushing, chewing, or splitting. Follow the recommended dose-escalation schedule to reduce the risk of tumor lysis syndrome (TLS). Dose adjustments may be required when used with strong CYP3A4 inhibitors or in patients with severe hepatic impairment.
Interaction: Strong CYP3A4 inhibitors may significantly increase Sonrotoclax exposure and should be avoided. CYP3A4 inducers may reduce therapeutic efficacy.
Side effects: Common adverse reactions include neutropenia, thrombocytopenia, anemia, diarrhea, nausea, fatigue, and tumor lysis syndrome (TLS).
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 is BaiYueDa® used for?
It is indicated for adults with relapsed or refractory mantle cell lymphoma who have previously received at least two systemic therapies, including a BTK inhibitor.
How should BaiYueDa® be taken?
It is taken orally once daily using a gradual dose-escalation schedule before reaching the maintenance dose.
Why is dose escalation required?
Gradual dose escalation helps reduce the risk of tumor lysis syndrome (TLS), a potentially serious treatment-related complication.
What are the common side effects?
Common adverse reactions include neutropenia, thrombocytopenia, anemia, nausea, diarrhea, fatigue, and tumor lysis syndrome.
BaiYueDa® | Sonrotoclax | Relapsed or Refractory MCL | DengYueRX
INN: Sonrotoclax
Indications: Relapsed or refractory mantle cell lymphoma (MCL)
Dosage Form: Tablet
Strength: 1 mg / 5 mg / 20 mg / 80 mg per tablet
