Description
Indication & Scope
BaiYueDa® Sonrotoclax Tablets provides single-agent oral treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more prior lines of systemic therapy.
- Mechanism: Selective, oral BCL-2 homology 3 mimetic inhibitor. It binds selectively to anti-apoptotic BCL-2 protein on malignant B lymphocytes, displaces pro-apoptotic BH3-only proteins, activates intrinsic mitochondrial apoptotic pathways and induces targeted death of mantle cell lymphoma tumor cells.
- Drug class: Oral selective BCL-2 small-molecule inhibitor / Targeted anti-B-cell lymphoma chemotherapeutic agent.
- Clinical use: Third-line monotherapy for relapsed/refractory mantle cell lymphoma in adults failing prior chemoimmunotherapy and BTK inhibitor regimens; durable oral single-agent disease control for patients unsuitable for autologous stem cell transplant.
| Generic Name | Sonrotoclax Tablets |
| Brand Name | BaiYueDa |
| Ingredient | Sonrotoclax |
| Dosage Form | Tablets |
| Package | 1mg*1 tablet*11 blisters/box;
5mg*1 tablet*11 blisters/box; 20mg*1 tablet*11 blisters/box; 80mg*1 tablet*11 blisters/box; 80mg*120 tablets/box |
| Conditions Treated | Relapsed or refractory mantle cell lymphoma (MCL) in adult patients |
| Taboos | Severe hypersensitivity to sonrotoclax or capsule excipients; active uncontrolled severe systemic infection; patients with baseline absolute neutrophil count <0.5×10⁹/L; pregnant and breastfeeding individuals |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed capsule blister packs stored at controlled room temperature 10°C–30°C, fully moisture-proof sealed packaging |
| Manufacturer | BeiGene (SuZhou) Biotechnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250074; H20250075; H20250076; H20250077 |
| Approval Date | Feb 11, 2026 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Initiate weekly ramp-up dose titration: 25 mg → 50 mg → 100 mg → 200 mg → 400 mg daily; maintain 400 mg oral once daily continuous maintenance dose after full titration.
Time: Single daily oral capsule taken at fixed consistent time, administered with food to boost systemic absorption and reduce gastrointestinal toxicity.
Instructions for use: Swallow capsules whole with water without splitting or chewing; perform baseline tumor lysis syndrome prophylaxis during dose escalation; monitor complete blood count weekly for the first 8 treatment weeks; interrupt dosing for severe neutropenia until hematologic recovery.
Interaction: Strong CYP3A4 inhibitors sharply elevate sonrotoclax plasma levels and tumor lysis syndrome risk; strong CYP3A4 inducers significantly reduce anti-tumor efficacy. Concurrent nephrotoxic agents increase electrolyte disturbance risk during TLS prophylaxis.
Side effects:
1. Common manageable adverse events: mild neutropenia, thrombocytopenia, fatigue, diarrhea, upper respiratory tract infection.
2. Life-threatening severe risks: tumor lysis syndrome (TLS), severe prolonged myelosuppression, invasive fungal infections.
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 anti-apoptotic protein is the exclusive molecular target of Sonrotoclax Tablets in relapsed mantle cell lymphoma?
The drug selectively targets and inhibits the BCL-2 anti-apoptotic protein overexpressed in malignant MCL B cells.
What mandatory clinical safety intervention is required during the multi-week dose ramp-up titration phase of Sonrotoclax Tablets?
Standard tumor lysis syndrome prophylaxis with intravenous hydration and urate-lowering medication to prevent fatal electrolyte derangements.
What routine laboratory monitoring must clinicians conduct weekly for the first eight weeks of continuous treatment of Sonrotoclax Tablets?
Complete blood count tracking absolute neutrophil and platelet levels to manage dose-limiting myelosuppression.
Why is a gradual weekly dose escalation schedule required instead of immediate full 400 mg maintenance dosing when using Sonrotoclax Tablets?
Slow titration mitigates the high risk of rapid massive tumor cell breakdown leading to severe tumor lysis syndrome at therapeutic concentrations.
BaiYueDa® | Sonrotoclax Tablets | MCL | DengYueRX
INN: Sonrotoclax Tablets
Indications: Recurrent or refractory mantle cell lymphoma (MCL)
Dosage Form: Tablets
Strength: 1mg/tablet; 5mg/tablet; 20mg/tablet; 80mg/tablet
