Description
Indication & Scope
BeiJieMai® Pimicotinib Hydrochloride Capsule treats adult symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection would lead to irreversible joint function loss or severe surgical complications.
- Mechanism: Highly selective oral colony-stimulating factor 1 receptor (CSF-1R) tyrosine kinase inhibitor. It blocks CSF-1R signaling in tumor-associated macrophages, eliminates inflammatory macrophage infiltration within TGCT lesions, reduces tumor volume and relieves joint pain and mobility impairment without surgical resection.
- Drug class: Oral selective CSF-1R small-molecule kinase inhibitor / Targeted therapy for tenosynovial giant cell tumor.
- Clinical use: Long-term continuous oral targeted therapy for unresectable symptomatic TGCT adult patients; achieves durable tumor shrinkage and improves joint function to avoid high-risk orthopedic surgery.
| Generic Name | Pimicotinib Hydrochloride Capsules |
| Brand Name | BeiJieMai |
| Ingredient | Pimicotinib Hydrochloride |
| Dosage Form | Capsules |
| Package | 25mg*60 capsules/box |
| Conditions Treated | Symptomatic tenosynovial giant cell tumor (TGCT) in adult patients unsuitable for surgical excision |
| Taboos | Severe hypersensitivity to pimicotinib hydrochloride or capsule excipients; patients with grade 4 baseline elevated liver enzymes; pregnant and breastfeeding individuals |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed blister capsule packs stored at controlled room temperature 10°C–30°C, moisture-resistant packaging |
| Manufacturer | Asymchem Life Science (Tianjin) Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250072 |
| Approval Date | Dec 16, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard daily oral dose 50 mg (two 25 mg capsules) administered once daily continuously.
Time: Single daily fixed-time oral dose, taken with food to reduce gastrointestinal adverse reactions.
Instructions for use: Swallow capsules whole with plain water without splitting or chewing; monitor serum liver transaminases and lipid panels every 4 weeks during initial treatment phase; adjust dose downward for persistent grade ≥2 liver toxicity.
Interaction: Strong CYP3A4 inhibitors increase systemic pimicotinib exposure and hepatic toxicity risk; strong CYP3A4 enzyme inducers reduce anti-tumor therapeutic efficacy.
Side effects: Common manageable adverse events: elevated blood cholesterol/triglycerides, mild fatigue, nausea, peripheral edema, elevated liver ALT/AST. Rare severe adverse events: grade 3+ hepatotoxicity, severe hyperlipidemia, persistent joint edema.
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 protein receptor kinase does Pimicotinib Hydrochloride Capsules selectively inhibit?
It is a highly selective inhibitor of colony-stimulating factor 1 receptor (CSF-1R).
What specific benign tumor disease is Pimicotinib Hydrochloride Capsules indicated to treat?
Symptomatic tenosynovial giant cell tumor (TGCT) in adult patients unsuitable for surgery.
What is the standard daily oral dose for Pimicotinib Hydrochloride Capsules therapy?
50 mg total daily dose, equivalent to two individual 25 mg capsules once per day.
What two routine blood lab markers require monthly monitoring after treatment initiation when using Pimicotinib Hydrochloride Capsules?
Liver transaminase enzymes (ALT/AST) and blood lipid panel (cholesterol, triglycerides).
BeiJieMai® | Pimicotinib Hydrochloride Capsules | TGCT | DengYueRX
INN: Pimicotinib Hydrochloride Capsules
Indications: Tenosynovial giant cell tumor (TGCT)
Dosage Form: Capsules
Strength: 25mg/capsule
