Donanemab approved in China for early Alzheimer's disease
China's second amyloid-targeting antibody arrived eleven months after lecanemab, with a stepped dosing schedule and label support for stopping once plaques are cleared.
At a glance
- Generic name
- Donanemab
- Brand
- 记能达 / Kisunla
- Development code
- LY3009806
- Regulatory status
- Approved in China (NMPA, 2024-12-17)
What happened
The NMPA approved donanemab injection, submitted by Eli Lilly, for adults with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia. The approval was published by the NMPA on 20 December 2024; Lilly and Chinese state media reported it on 18 December.
Donanemab had been approved in the United States in July 2024. China's approval came about five months later, as a Class 1 innovative biologic under priority review.
Why it matters
Donanemab clears existing amyloid plaques rather than only limiting their formation, and its label supports pausing treatment once plaque levels reach a minimum — Lilly states it is the only amyloid-targeting therapy with label support for stopping.
The dosing schedule is stepped rather than flat: 350 mg, then 700 mg, then 1050 mg, then 1400 mg every four weeks. For a patient weighing treatment burden and infusion frequency, that difference is more consequential than headline efficacy numbers.
Access in China
Where it is available
Nationally approved. Prescribed by cognitive-disorder and memory clinics at large public hospitals, after amyloid pathology has been confirmed. Which centres currently hold stock and accept new international self-pay patients is not published; we confirm it during intake.
Language support
International departments at major public hospitals provide English support. Standard neurology clinics generally do not.
Typical timeline
Diagnosis and amyloid confirmation, APOE ε4 and safety work-up, then a four-weekly infusion schedule with periodic MRI monitoring. No public data on waiting time.
Cost
No figure is published here. We do not publish a price we cannot back with a written quotation from a specific hospital — ask us and we will obtain it in writing before you commit to anything.
What we don't know
These are the questions patients actually ask, and the ones nobody publishes. We list them rather than filling them with guesses.
- •Which hospitals currently hold stock and can start a new patient.
- •Per-infusion list price, and whether any assistance programme applies to foreign self-pay patients.
- •Whether each centre accepts a blood biomarker for amyloid confirmation or requires PET or CSF.
- •Locally applied MRI monitoring schedule after infusion.
Sources
- NMPA — approval of donanemab injection
Original language: Chinese · Published 2024-12-20
- Xinhua — Lilly's donanemab approved in China
Original language: Chinese · Published 2024-12-18
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Published 2024-12-17 . This page is general information, not medical advice, diagnosis or a recommendation for any individual. Regulatory status, availability and price can change without notice — confirm with the treating hospital before making decisions.