Timing Affects Speed, Not Total Exposure

CureGene Presents Evategrel China–US PK/PD and Food-Effect Data at AHA 2026

SHANGHAI, Nov. 8, 2026 /PRNewswire/ -- Clopidogrel does not work the same way in every patient. In East Asian populations the gap is wider still: a share of patients get too little platelet inhibition at the standard dose, and some get none. Effective antiplatelet therapy carries its own price, because the harder platelets are suppressed, the greater the risk of bleeding, and physicians must strike that balance every day. In acute ischaemic stroke the clock runs in hours, and today's antiplatelet drugs are not called on to be both fast and safe. Roughly 40% of stroke patients also arrive unable to swallow, and there is still no injectable option for them. Each of these problems comes back to one question: can the way a drug is absorbed, and how quickly it starts working, be counted on?

Evategrel (CG-0255), an investigational P2Y12 receptor antagonist, was designed with that question in mind.

Results from two clinical pharmacology studies in healthy volunteers were presented as a poster at the American Heart Association (AHA) Scientific Sessions 2026 in Chicago (November 6–9). One compared the pharmacokinetics and pharmacodynamics of oral Evategrel in Chinese and US participants; the other examined how food affects exposure to the oral formulation and its antiplatelet effect.

Why Evategrel Bypasses CYP450 and Does Not Rely on CYP2C19

Clopidogrel is given as an inactive compound. The liver has to oxidise it through several CYP450 steps before any H4, its active metabolite, is formed, which is why onset usually takes hours and why people who carry loss-of-function CYP2C19 variants respond poorly or not at all. Evategrel is built differently. It is a thiol prodrug, and a single carboxylesterase-mediated hydrolysis step releases the same H4. No CYP450 oxidation is involved, so onset does not depend on CYP2C19, and the response is more consistent from one patient to the next.

Chinese and US Participants Showed Comparable PK and PD

Both studies used the same design, one run in the United States and one in China. Oral Evategrel was absorbed quickly and cleared quickly. At matched dose levels, plasma concentrations and platelet inhibition traced the same course in the two populations, and inhibition rose with dose rather than differing by ethnicity.

Food Slows Absorption, but Total Exposure Is Unchanged

Taken on an empty stomach, Evategrel was absorbed faster and peaked sooner; after a meal the peak came later and lower. Total exposure and the degree of platelet inhibition, however, came out about the same either way. The explanation lies in how the drug works. H4 binds covalently and irreversibly to the P2Y12 receptor, so what matters is how much H4 accumulates over time, not how high the concentration spikes at any one moment.

One Molecule, Two Ways to Use It

Taken orally, Evategrel produces clear platelet inhibition within about 30 minutes. During maintenance therapy, patients do not have to schedule doses around meals, and when faster onset is wanted, a dose taken fasting is absorbed sooner. Given intravenously, it is intended for the acute phase of ischaemic stroke, giving patients who cannot swallow another route to treatment.

The two studies together answer two practical questions. First, do Chinese and US patients handle the drug the same way? That matters for running global trials in parallel. Second, how should the oral formulation be taken in real-world use?

Evategrel comes from CureGene's proprietary A-proX™ prodrug platform. A registration trial is running in the United States, and registration trials in China are due to begin shortly.

About AHA Scientific Sessions 2026

AHA Scientific Sessions is one of the largest and most influential meetings in cardiovascular medicine. The 2026 edition runs November 6–9 at McCormick Place in Chicago, spanning basic science, translational research, clinical trials and practice updates.

About Evategrel (CG-0255)

Evategrel (CG-0255) is a P2Y12 receptor antagonist discovered and developed by CureGene. It is a thiol prodrug: one carboxylesterase-mediated hydrolysis step releases H4 (CG-0236), the same active metabolite that clopidogrel produces, with no CYP450 oxidation along the way. To the Company's knowledge, Evategrel is the first P2Y12 receptor antagonist built on a thiol prodrug design, and the only one being developed in both oral and intravenous forms. It is intended for the same indications as clopidogrel, namely myocardial infarction and stroke, and the intravenous form gives the P2Y12 class an option for stroke patients who cannot take a tablet.

For further information on Evategrel, please visit https://www.curegene.com.cn/en.

About CureGene Pharmaceutical

CureGene Pharmaceutical (Shanghai CureGene Pharmaceutical Co., Ltd.) was founded in 2018 and combines proprietary platform technologies with efficient in-house discovery. Its work focuses on cardiovascular and cerebrovascular disease and on antiviral therapy, with the aim of building a China-based, globally oriented biopharma, and several pipeline assets discovered on its own platforms carry broad market potential and independently held global intellectual property. CureGene employs scientists and returning overseas researchers with international experience, and has moved candidates from discovery into the clinic quickly. Its pipeline has the potential to yield first-in-class or best-in-class therapies.

Forward-Looking Statements

This release contains forward-looking statements about the Company's research plans, the timing of its clinical trials and the potential value of its candidates. Those statements rest on current expectations and assumptions and are subject to the risks inherent in drug development, to regulatory decisions, to uncertain clinical outcomes and to the funding environment; actual results may differ materially. Except where required by law, the Company undertakes no obligation to update them after the date of this release. The drug described here has not been approved by any regulatory authority, and its safety and efficacy are still being studied.

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SOURCE CureGene