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Bayer wins China approval for stroke drug Asundexian, sold as Sunharbo

Nate Gregory
Published Oct 28, 2026
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Summary:
  • China's drug regulator cleared Bayer's Asundexian, branded Sunharbo, to lower the risk of another stroke in adults who have already had one.
  • In a study, adding Asundexian to antiplatelet therapy cut repeat strokes by 26% without increasing serious bleeding.
  • Bayer's stock jumped as much as 3.4% on Monday and has advanced almost 23% year to date.

What happened

Bayer said Monday that China's National Medical Products Administration approved Asundexian to reduce the chance of a second stroke in adults with a prior event. The pill will be sold as Sunharbo and targets Factor XIa, a clotting protein.

It is the first Factor XIa inhibitor to win any regulatory approval. Bristol Myers Squibb and Johnson & Johnson are testing a rival candidate, milvexian.

Trial details and competitive backdrop

A clinical study found Asundexian, when used alongside antiplatelet therapy, reduced secondary stroke risk by 26% without increasing serious bleeding. Stefan Oelrich, who leads Bayer's pharma unit, has said the drug - which previously failed in a heart condition study - could reach blockbuster scale as a stroke therapy.

Bayer is seeking approvals in other markets as well, with submissions filed in countries that include the US and Europe.

New developments in healthcare can reshape investor expectations and decision making. We're hosting our first ever investor livestream on 11/17 to show you how to use ChatGPT and Claude to invest like a pro, hosted by Briefs Finance CEO Jaspreet Singh. Save your seat.

Why China matters

Bayer notes that in China, stroke stands as the foremost cause of death and long-term disability, and rates have risen in recent years. About 1 in 10 individuals who make it through a noncardioembolic ischemic stroke experience a recurrence within one year, even with today's preventive measures.

The bottom line for investors

Bayer says Sunharbo should help revive its pharma growth engine, which is contending with generics hitting blood thinner Xarelto and eye drug Eylea. Its newer drugs include the menopause therapy Lynkuet and the heart treatment Beyonttra. Shares climbed as much as 3.4% Monday, and the stock has gained nearly 23% year to date.

Smart investors look for reliable ways to gain a modest edge over time. On 11/17, our CEO Jaspreet Singh goes live for our first ever investor livestream on how to use ChatGPT and Claude to invest like a pro. Register to join him.

Disclosure

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