shouyaoze conteltinib granules 450mg or 600mg per sachet

Description

Indication & Scope

Shouyaoze contains conteltinib, a novel oral ALK inhibitor in granule formulation for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Mechanism: Inhibits ALK kinase activity and related signaling pathways, including FAK signaling, to suppress tumor cell proliferation and survival.
Drug class: ALK tyrosine kinase inhibitor (ALK-TKI).
Clinical use: First-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior ALK inhibitor therapy.

Specification

Generic Name	Conteltinib
Brand Name	Shouyaoze
Ingredient	Each sachet contains 450 mg or 600 mg conteltinib
Dosage Form	Granules
Package	450 mg × 14 sachets/box or 600 mg × 14 sachets/box
Conditions Treated	ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients without prior ALK inhibitor therapy
Taboos	Hypersensitivity to conteltinib or any component of the product
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store below 30°C, protect from moisture
Manufacturer	Shouyao Holdings (Beijing) Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	CXHS2400109; CXHS2400110
Date of Revision	To be determined
Shelf Life	Refer to the approved package insert

How to use ?

Recommended Dose: 600 mg orally once daily; reduce to 450 mg once daily if dose reduction is required.

Time: Administer once daily on an empty stomach (at least 2 hours after a meal or at least 1 hour before a meal).

Instructions for use: Disperse the granules in 50–100 mL of warm water, stir thoroughly, and administer orally. Consume the prepared suspension within 2 hours. Continue treatment until disease progression or unacceptable toxicity occurs.

Interaction: Avoid concomitant use with strong CYP3A inhibitors or inducers; dose adjustment may be required if coadministration cannot be avoided.

Side effects: Diarrhea, vomiting, abdominal pain, nausea, increased γ-glutamyl transferase (GGT), and elevated alanine aminotransferase (ALT).

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, indication, 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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

Is cobimetinib a chemotherapy drug?

No, cobimetinib and vemurafenib are not conventional chemotherapeutic agents, with distinct mechanisms of action. They exert anti-tumor effects by specifically targeting cancer cells to suppress tumor proliferation and metastasis.

What class of drug is cobimetinib?

Cobimetinib belongs to the therapeutic class of kinase inhibitors. It functions by inhibiting the activity of abnormal proteins that drive cancer cell proliferation, thereby slowing or halting cancer progression and metastasis.

What does cobimetinib target?

Cobimetinib is an anti-tumor agent and selective inhibitor of the MEK (mitogen-activated extracellular kinase) signaling pathway, indicated for unresectable or metastatic melanoma.

When was cobimetinib approved by the FDA?

On November 10, 2015, cobimetinib (brand name Cotellic, developed by Genentech) obtained FDA approval. It is indicated for combination use with vemurafenib (Zelboraf) to treat adult patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations.

Shouyaoze® Conteltinib | Lung Cancer | DengYueRX

INN: Conteltinib
Indications: Relapsed or refractory peripheral T-cell lymphoma (PTCL)
Dosage Form: Granules
Strength: 450 mg/sachet; 600 mg/sachet