Alexander Krupp: Asundexian Receives Priority Review Designation from China‘s NMPA
Alexander Krupp, Executive Clinical Product Excellence Lead, VP at Bayer, shared on LinkedIn:
”Exciting news: Asundexian receives Priority Review designation from China‘s NMPA.
The numbers behind this moment tell an extraordinary story.
Regulatory Context:
In China, cardiovascular drugs represent just 4.3% of new drug approvals (2020-2024): only 12-13 cardiovascular NDAs in five years.
Thus, Priority Review designation carries exceptional weight.
While 56% of all innovative drugs receive priority review, CV drugs rarely make the cut in a landscape with a strategic priority on oncology (35-48% of approvals).
Patient Reality:
China faces the world‘s largest stroke crisis:
- 17.8 million people living with stroke
- 3.4 million new strokes annually (9,300 every day)
- 2.3 million stroke deaths per year (6,300 daily)
- N1 cause of death and disability in the nation
- 5.6-17.7% recurrence rate within 12 months equals up to 3 million patients at risk of second stroke annually
Health System Burden:
- ¥58 billion ($8.5B USD) in annual hospitalization costs alone
- More than ¥400 billion total economic burden annually
- Yet <10% of eligible patients receive acute reperfusion therapy
- Secondary prevention is where the real impact lies
Why NMPA Moved Quickly:
Our OCEANIC-STROKE data (NEJM, 2025) in 12,327 patients showed:
- 26% reduction in recurrent ischemic stroke (HR 0.74, P<0.001)
- No increase in major bleeding (1.9% vs 1.7% placebo, P=NS)
- A Factor XIa inhibitor that breaks the decades-old efficacy-safety trade-off
The Math That Matters:
A 26% reduction in recurrent stroke could prevent 600,000-900,000 recurrent strokes annually in China alone.
For patients whose mean age is 65.7 years – a full decade younger than Western stroke populations – that‘s productive years saved, families preserved, and disability prevented.
To the team who made this possible:
You generated data that convinced one of the world‘s most rigorous regulators to accelerate review in an underserved therapeutic area.
You navigated regulatory complexity.
You never stopped believing Chinese patients deserved access to this innovation… FAST! This achievement is yours.
Priority review isn‘t just regulatory acceleration – it‘s recognition that a therapy addresses critical unmet need.
In a country where stroke kills more people than any other cause, where CV innovation represents <5% of approvals, and where 17.8 million patients are waiting, that recognition means everything.
Key References:
1. China NMPA Priority Review
2. OCEANIC-STROKE Trial (NEJM)
3. China Stroke Burden and Epidemiology
Title: China stroke surveillance report 2021
Authors: Wen-Jun Tu, Long-De Wang on behalf of the Special Writing Group of China Stroke Surveillance Report
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