Description
Indication & Scope
BeiJieMai® (Pimicotinib Hydrochloride) is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) in whom surgical resection is likely to result in functional limitation or severe morbidity.
- Mechanism: Pimicotinib is a highly selective colony-stimulating factor-1 receptor (CSF-1R) inhibitor. It selectively inhibits CSF-1R signaling, reducing the accumulation of CSF-1R-dependent macrophages within the tumor microenvironment, thereby decreasing tumor burden and improving disease-related symptoms.
- Drug Class: CSF-1R Inhibitor.
- Clinical Use: First-line systemic treatment for adult patients with symptomatic TGCT who are not suitable candidates for surgery or whose surgery may result in severe functional impairment.
| Generic Name | Pimicotinib Hydrochloride Capsules |
| Brand Name | BeiJieMai® |
| Ingredient | Pimicotinib Hydrochloride |
| Dosage Form | Capsule |
| Package | 25 mg × 30 capsules/bottle, 1 bottle/box |
| Conditions Treated | enosynovial Giant Cell Tumor (TGCT) |
| Taboos | Hypersensitivity to pimicotinib hydrochloride or any component of the formulation. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store below 30°C in the original package. Protect from moisture. |
| Manufacturer | Merck Serono (Beijing) Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250072 |
| Date of Revision | 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: The recommended dose is 50 mg (two 25 mg capsules) orally once daily according to the approved prescribing information.
Time: Administer orally once daily. Swallow the capsules whole with water. The medicine may be taken with or without food.
Instructions for use: Treatment should be continued until disease progression or unacceptable toxicity occurs. Dose interruption or reduction may be required for adverse reactions according to the approved prescribing information. Patients should take the medication at approximately the same time each day. If a dose is missed, it should be taken as soon as possible on the same day. If it is close to the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not take a double dose.
Interaction: Pimicotinib is primarily metabolized by CYP3A enzymes. Concomitant use with strong CYP3A inhibitors or inducers may alter drug exposure. Patients should inform their healthcare provider of all concomitant medications before initiating treatment, and dose modifications may be required according to the approved prescribing information.
Side effects: The most commonly reported adverse reactions include hair color changes, periorbital edema, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), increased blood creatine phosphokinase, rash, fatigue, nausea, and pruritus. Liver function and laboratory parameters should be monitored regularly during treatment.
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 BeiJieMai® used for?
It is used to treat adults with symptomatic TGCT when surgical resection is likely to result in functional limitation or severe morbidity.
How should BeiJieMai® be taken?
The recommended dosage is 50 mg (two 25 mg capsules) taken orally once daily, with or without food, following the approved prescribing information.
What are the common side effects?
Common adverse reactions include hair color changes, periorbital edema, elevated liver enzymes, rash, fatigue, nausea, and increased creatine phosphokinase levels.
Is BeiJieMai® a prescription medicine?
Yes. BeiJieMai® is a prescription-only medicine (Rx) and should be used under the supervision of a qualified healthcare professional.
BeiJieMai® | Pimicotinib Hydrochloride | Tenosynovial Giant Cell Tumor (TGCT) | DengYueRX
INN: Pimicotinib Hydrochloride
Indications: TGCT adult high surgical‑risk therapy
Dosage Form: Capsule
Strength: 25 mg/Capsule
