By Fineline Cube 
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a public announcement that Servier’s vorasidenib, the world’s first dual isocitrate dehydrogenase (IDH) inhibitor, has been incorporated into the “Support Anti‑tumor Drugs R&D for Kids (SPARK)” initiative. The drug is slated for treating Grade 2 astrocytoma or oligodendroglioma harboring a susceptible IDH1 or IDH2 mutation.
Product Snapshot
- Vorasidenib – a pioneering dual‑targeted IDH1/IDH2 inhibitor; the first innovative IDH‑mutant glioma therapy introduced in 20 years.
- Indication – Grade 2 diffuse gliomas (astrocytoma or oligodendroglioma) with wild‑type or mutant IDH1/IDH2.
- Global Footprint – Approved in the U.S. (Aug 6, 2024), Canada, Australia, Israel, Switzerland, UAE; first Asian “use” via the Boao Lecheng Pilot Zone (Nov 24, 2024) and early‑access launch in Beijing (Jul 2, 2025).
Regulatory Milestones
| Date | Authority | Action |
|---|---|---|
| 13 Nov 2025 | CDE/NMPA | Vorasidenib added to the SPARK project |
| 6 Aug 2024 | FDA | U.S. approval granted |
| 24 Nov 2024 | Hainan Boao Lecheng Zone | First Asian administration |
| 2 Jul 2025 | Beijing Health Authorities | Early‑access approval as urgently needed import |
Clinical Development Highlights
- SPARK Inclusion – positions vorasidenib alongside other cutting‑edge pediatric oncology programs, expanding access for children with IDH‑mutant diffuse glioma.
- Early‑Access in Beijing – now available in designated medical institutions within the Tianzhu Comprehensive Bonded Zone, giving Chinese clinicians an immediate therapeutic option.
- International Momentum – the drug’s approval trajectory mirrors Servier’s strategy to broaden the global IDH‑mutant glioma market, projected to reach $3–$5 B by 2034.
Market & Commercial Outlook
The IDH‑mutant glioma segment remains the most neglected within neuro-oncology, with a cumulative market size approaching $1.8 B worldwide by 2030. Vorasidenib’s dual‑targeted mechanism—simultaneous inhibition of IDH1 and IDH2, the “on‑ and off‑cancer” enzymatic axis—offers a superior therapeutic index compared with single‑IDH inhibitors. Early 2025 data from the U.S. phase III trials indicate a 12–15 % average reduction in lesion volume at 12 months, underscoring its clinical promise for the Chinese patient base.
Forward‑Looking Statements
This briefing contains forward‑looking statements regarding regulatory actions, trial data, and commercial opportunities. Actual results may differ materially.-Fineline Info & Tech