HanKang Capital Portfolio | CureGene's Elifugrel (CG-0255) Enrolls First Subject in U.S. Pivotal Registration Trial, Accelerating Global Commercialization

A patient walked into a clinical site in the United States this week and became the first person to enroll in a pivotal registration trial for a drug that its developers believe could reshape how the world treats blood clots. The moment marks a turning point for CureGene Pharmaceutical Co., Ltd., a Chinese biotech company betting that its novel antiplatelet therapy can outperform drugs that have dominated cardiology for decades.

CureGene announced that the first subject has been enrolled in its U.S. pivotal registration clinical trial for CG-0255 (elifugrel), a next-generation P2Y12 receptor inhibitor that is the world's first antiplatelet agent available in both intravenous and oral formulations. The milestone propels the drug into the final stretch of global clinical development and sets the stage for a potential New Drug Application (NDA) submission in the United States.

Cardiovascular and cerebrovascular diseases remain the leading cause of death and disability worldwide. Current standard therapies—chiefly clopidogrel, ticagrelor, and prasugrel—carry limitations that leave hundreds of millions of patients underserved. CureGene is wagering that CG-0255 can fill those gaps.

A Dual-Formulation First

CG-0255 was built on CureGene's proprietary "Puyu" prodrug platform. Its design delivers two advantages that have no parallel in the current antiplatelet arsenal.

First, it is the only P2Y12 inhibitor available as both an intravenous injection and an oral capsule—covering the full spectrum of clinical scenarios from emergency rooms to long-term outpatient care. Second, it uses an entirely new metabolic pathway: the prodrug is activated by carboxylesterases found throughout the human body, completely bypassing the liver's CYP450 enzyme system, and in particular the CYP2C19 enzyme.

That distinction matters enormously. Clopidogrel, the most widely used P2Y12 inhibitor globally, depends on CYP2C19 for activation. Nearly 60% of people of East Asian descent carry variants of this enzyme that render clopidogrel less effective or ineffective—a phenomenon known as "clopidogrel resistance." CG-0255's mechanism eliminates that problem at the molecular level.

Three Clinical Advantages

Earlier clinical data have pointed to three standout properties:

Speed. The intravenous formulation reaches peak effect in under 15 minutes; the oral capsule does so in under 30 minutes. That rapid onset could close a critical gap in acute stroke treatment, where every minute of delayed antiplatelet therapy translates into lost brain tissue.

Potency at a fraction of the dose. The clinical dose of CG-0255 is just 1% of the clopidogrel dose, potentially reducing the burden on patients and lowering the risk of dose-related side effects.

Safety and consistency. Because it does not rely on genetic enzyme variants for activation, CG-0255 shows no significant inter-patient variability. The risks of major bleeding and drug-drug interactions are markedly lower—features that make it especially attractive for elderly patients with multiple comorbidities who are already taking several medications.

The U.S. Trial

The U.S. pivotal registration trial will evaluate both the injectable and oral forms of CG-0255 across a broad set of indications: acute coronary syndrome (ACS), recent myocardial infarction, ischemic stroke, and peripheral artery disease. The breadth of the trial signals CureGene's ambition to position CG-0255 as a comprehensive platform therapy rather than a niche product.

"The enrollment of the first subject in the U.S. registration clinical trial is an important milestone in CureGene's journey as a global innovator," said Dr. Gongxin He, founder and chief executive officer of CureGene. "Cardiovascular and cerebrovascular diseases are the leading cause of death and disability worldwide, and existing treatment options leave significant unmet needs. With its novel mechanism and dual-dosage-form advantages, elifugrel has the potential to reshape the global antiplatelet treatment landscape."

China in Parallel

While the U.S. trial advances, development in China is moving in parallel. CureGene has received clinical trial approval from China's Center for Drug Evaluation (CDE), and a Phase II trial for the ischemic stroke indication is poised to begin. The dual-track strategy in both the U.S. and China is designed to enable simultaneous regulatory filings and give CG-0255 a head start in the world's two largest pharmaceutical markets.

The company has said the drug could receive regulatory approval as early as 2027.

Backed by HanKang Capital

CureGene, founded in 2018, has drawn backing from HanKang Capital, a healthcare-focused venture fund that led the company's Pre-A round in 2019 and has continued to invest in subsequent rounds. HanKang Capital's portfolio includes several listed biotech companies such as Akeso (09926.HK), InnoCare (09969.HK, 688428.SH), Keymed Biosciences (02162.HK), and Abbisko (02256.HK), among others.

The first patient's enrollment in the U.S. is more than a regulatory checkbox. It is a signal that a Chinese-origin drug built on a genuinely novel mechanism may be ready to compete on the world stage. Whether CG-0255 can deliver on its promise in late-stage trials will determine whether it becomes a best-in-class therapy for the hundreds of millions of patients living with cardiovascular risk—or joins the long list of candidates that looked brilliant in early data but stumbled under the weight of larger, more demanding studies.

For now, CureGene has earned the right to be taken seriously. The data will decide the rest.