Tibsovo (Ivosidenib) 250mg Tablets — First-in-Class IDH1 Inhibitor for AML | China | GLT

Generic Information: Tibsovo (Ivosidenib) — China Approved Originator

Tibsovo (拓舒沃), the originator brand of ivosidenib, is the first IDH1 inhibitor approved in Mainland China, registered under the license number 国药准字HJ20220002 for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) carrying a susceptible IDH1 mutation. The molecule was discovered by Agios Pharmaceuticals; today the product is owned worldwide by the French pharmaceutical group Servier (Servier Pharmaceuticals LLC is the listed marketing authorization holder), which took over development and commercialization across Greater China after previously licensing it to a regional partner. This listing is the China-approved originator version, sourced through China's licensed hospital and DTP pharmacy distribution channel.

What makes ivosidenib remarkable is its target: mutated isocitrate dehydrogenase-1 (IDH1), an enzyme alteration found in roughly 15–20% of AML patients. No conventional chemotherapy, and no other approved targeted agent, acts on this metabolic vulnerability — which is exactly why Tibsovo matters for patients who have exhausted standard options.

What Is Tibsovo 拓舒沃 (Ivosidenib) 250 mg?

Tibsovo is a blue, oval, film-coated oral tablet containing 250 mg of ivosidenib, supplied in bottles of 60 tablets — a one-month supply at the standard once-daily dose. The tablet is taken by mouth at approximately the same time each day, with or without food, offering a profoundly more convenient routine than the intensive inpatient chemotherapy that older AML patients often cannot tolerate. In China the brand is known as 拓舒沃, and the product is registered as an imported originator medicine with stability and quality documentation on file with the national regulator.

How Does Ivosidenib (IDH1 Inhibitor) Work in AML?

Mutant IDH1 enzymes produce 2-hydroxyglutarate (2-HG), an oncometabolite that accumulates inside leukemia cells and blocks their ability to mature into healthy blood cells. Ivosidenib selectively binds and inhibits the mutated IDH1 enzyme, driving 2-HG levels down and releasing that differentiation block. Leukemic blasts thereby regain the capacity to develop into functional cells — a mechanism oncologists call differentiation therapy. Because it acts on cancer metabolism rather than DNA damage, ivosidenib works even in patients refractory to proteasome-pathway and standard cytotoxic approaches, and it combines rationally with hypomethylating agents such as azacitidine.

Indications for Tibsovo in China

• Adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible IDH1 mutation, verified by an adequately validated diagnostic test.
• Beyond mainland China, regulators have additionally cleared ivosidenib for newly diagnosed IDH1-mutated AML in older or less fit adults (in combination with azacitidine) and for previously treated IDH1-mutated cholangiocarcinoma; Chinese patients with those profiles sometimes access the drug through named-patient channels, which GLT can discuss case by case.

Dosage of Tibsovo (Ivosidenib) 250 mg Tablets

The standard dose is 250 mg (one tablet) once daily, swallowed whole with water, at roughly the same time each day, with or without food. The tablet should not be split, crushed, or chewed, and dosing should not accompany a high-fat meal. Treatment continues until disease progression or unacceptable toxicity. Patients are monitored with baseline and serial ECGs for QTc prolongation and electrolyte panels, and prescribers watch for differentiation syndrome, a class-effect inflammatory reaction that responds to corticosteroids when recognized early. Dose reduction or interruption schedules for specific adverse reactions are described in the prescribing information.

Side Effects of Ivosidenib (Tibsovo)

In clinical use the most frequently reported adverse reactions include fatigue, leukopenia and neutropenia, diarrhea, edema, nausea, vomiting, stomatitis, abdominal pain, and QTc interval prolongation on ECG. Differentiation syndrome — fever, rapid weight gain, respiratory distress, and pulmonary infiltrates — is a serious but manageable risk if anticipated. Regular blood counts, cardiac monitoring, and prompt communication with the treating hematologist are essential throughout therapy. Patients should avoid grapefruit products and review every co-medication with their physician, since several common drugs interfere with ivosidenib metabolism.

Storage and Handling of Tibsovo Tablets

Store bottles at 20°C–25°C (68°F–77°F), excursions permitted between 15°C and 30°C, tightly closed in the original container and protected from moisture. Keep out of reach of children. Do not use tablets past the printed expiry date, and return any unused medicine to a pharmacy for safe disposal rather than discarding it in household waste.

Why Choose the China-Sourced Tibsovo Through GLT?

The China version of Tibsovo is the identical originator molecule sold in the United States and Europe, yet its hospital and DTP-pharmacy pricing in China sits far below the American list price — typically around half or less of what the same bottle of 60 tablets costs at US retail. For international buyers without access to the US product, the China channel offers genuine originator material, full batch documentation, and a much more sustainable cost profile for long-term oral therapy. GIVE LIFE TIME LIMITED (GLT) verifies registration status, batch authenticity, and cold-chain-independent ambient shipping conditions for every China order we handle.

How to Order Tibsovo (Ivosidenib) from China

To order Tibsovo (ivosidenib 250 mg) sourced from Mainland China, contact GIVE LIFE TIME LIMITED (GLT). We serve hospital procurement teams, licensed pharmacy wholesalers, physician buyers, and individual patients and their families. Reach us on WhatsApp at +86 15234153837 or email [email protected]; our team will confirm current availability, documentation, and shipping to your region.

FAQ: Tibsovo (Ivosidenib) China Version

Q: Is the China Tibsovo the same drug as the US Tibsovo?
A: Yes. It is the same originator ivosidenib molecule, now owned by Servier worldwide; China's regulator approved it as 拓舒沃 and the license is held by Servier Pharmaceuticals LLC.

Q: What does IDH1-mutant AML mean?
A: Roughly one in six to seven AML patients carries a mutation in the IDH1 gene. A validated test on a bone marrow sample determines whether ivosidenib is appropriate.

Q: How should Tibsovo be taken?
A: One 250 mg tablet once daily by mouth, whole, with or without food — but not with a high-fat meal — until the physician advises otherwise.

Q: How much cheaper is the China version?
A: Chinese hospital pricing typically runs around half or less of the US retail price for the same 60-tablet bottle, which is why many international buyers source the originator through the China channel.

Q: How do I order Tibsovo through GLT?
A: Message WhatsApp +86 15234153837 or email [email protected] with your quantity and destination; GLT confirms documentation, pricing, and delivery details directly.