Pemazyre (Pemigatinib) 9mg*14 | Innovent China NMPA | GLT

Generic Information: Pemazyre (Pemigatinib) — China-Mainland

This is the China-Mainland presentation of Pemazyre, the originator pemigatinib. In China, pemigatinib is commercialized by Innovent Biologics under license from Incyte Corporation, which discovered the drug; the Chinese brand name is "达伯坦" (Pemazyre). It was approved by China's NMPA as the first selective FGFR inhibitor for cholangiocarcinoma, for adults with previously treated, unresectable locally advanced or metastatic bile duct cancer carrying an FGFR2 fusion or rearrangement. This listing is the 9 mg presentation in a 14-tablet pack.

The China approval was supported by the global FIGHT-202 study together with a Chinese bridging study, which confirmed favourable efficacy and a tolerability profile in Chinese patients. Because Innovent handles commercialization across Mainland China, Hong Kong, Macau and Taiwan, buyers should recognise both the Incyte origin and the Innovent distribution when verifying documentation.

What Is Pemazyre Used For?

Pemazyre treats adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma whose tumour carries an FGFR2 fusion or rearrangement, confirmed by a validated diagnostic test. Cholangiocarcinoma is the second most common primary liver malignancy and is frequently diagnosed at an advanced stage, leaving few effective options. Pemazyre is the first targeted oral therapy approved in China for this specific molecular subtype.

How Does Pemazyre Work?

Pemigatinib selectively inhibits FGFR1, FGFR2 and FGFR3 kinases. In cholangiocarcinoma with an FGFR2 fusion or rearrangement, the FGFR pathway is abnormally switched on and drives tumour growth. By blocking this signalling, Pemazyre slows disease progression. It is a small-molecule targeted therapy rather than a broadly cytotoxic agent, which contributes to its oral, once-daily dosing.

Indications

• Previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, confirmed by a validated test.
• Adult patients who have progressed after at least one prior line of systemic therapy.

Dosage and Administration

The recommended dose is 13.5 mg once daily for 14 consecutive days followed by 7 days off, in repeating 21-day cycles. Tablets are taken orally with or without food and swallowed whole. The 9 mg strength supports dose adjustments. Patients require monitoring of phosphate, renal function and eye health, with ophthalmologic evaluation for any visual symptoms.

Side Effects

Common adverse reactions include hyperphosphatemia, diarrhoea, stomatitis, dry mouth, fatigue, nausea and alopecia. A boxed warning highlights the risk of serous retinal detachment, so visual changes must be reported promptly. Dry eye, nail disorders and liver enzyme elevations are also observed, and most adverse events are grade 1 or 2 in severity.

Storage

Store at room temperature, below 25°C, in the original package, away from moisture and out of the reach of children. Use before the printed expiry date.

Why Choose the China Version of Pemazyre?

The China-Mainland Pemazyre is priced substantially below the US list price of the same medicine — roughly half or lower — which makes it one of the more economical ways to access originator pemigatinib. GLT documents each batch and guides international buyers through the export and import requirements for sourcing the China presentation. For institutions and patients able to source through China, this is a meaningful cost-saving route without switching to a generic.

How to Order Pemazyre (China) from GLT

To order the China-Mainland Pemazyre 9 mg (14 tablets), message GLT on WhatsApp at +86 15234153837 or email [email protected]. State your quantity, destination and order type, and we confirm the current China price, batch origin and required documentation before dispatch.

FAQ

Who commercializes Pemazyre in China? Innovent Biologics commercializes pemigatinib (达伯坦/Pemazyre) in China under license from Incyte, which discovered the drug.

Is Pemazyre reimbursed in China? Pemigatinib is not yet on China's national reimbursement drug list; access may be supported in certain regions through supplementary insurance schemes.

Why is the China version cheaper? China's market pricing for pemigatinib is meaningfully lower than the US list price, making the China presentation a more economical originator option.