Kejun Pharma’s Efugrel (CG-0255) Completes First Subject Enrollment in U.S. Pivotal Registration Trial, Accelerating Global Commercialization

ShanghaiJune 20, 2026 /PRNewswire/ — Kejun Pharmaceuticals today announced that its self-developed, first-in-class next-generation antiplatelet drug Efugrel (CG-0255) has successfully completed the enrollment of the first subject in a pivotal registration clinical trial in the United States. This marks the drug’s entry into the final sprint phase of global clinical development, taking a substantial step toward submitting a New Drug Application (NDA) in the U.S. and benefiting patients with cardiovascular and cerebrovascular diseases worldwide.

Efugrel (CG-0255) is the core product developed by Kejun Pharmaceuticals through its proprietary “Puyu” prodrug technology platform, featuring two unique advantages:

1. Dual Formulation Capability: It is the world’s first P2Y12 receptor inhibitor available in both intravenous and oral formulations, comprehensively covering diverse clinical scenarios;
2. Novel Metabolic Pathway: It employs an innovative thiol-based hydrolytic prodrug design, activated through carboxylesterase enzymes widely present in the human body, completely bypassing the liver CYP450 (especially CYP2C19) enzyme-dependent pathway.

This mechanism fundamentally addresses the long-standing clinical issue of “clopidogrel resistance” (affecting nearly 60% of the East Asian population) and fully overcomes the pain points of existing drugs, such as slow onset of action, significant individual variability, and high risk of drug-drug interactions, representing a revolutionary breakthrough in antiplatelet therapy.

This U.S. registration clinical trial will comprehensively evaluate the efficacy and safety of Efugrel injection and oral capsules in indications such as acute coronary syndrome (ACS), recent myocardial infarction, ischemic stroke, and peripheral artery disease. Preliminary clinical data for Efugrel have already demonstrated three core advantages:

1. Rapid Onset, Buying Critical Time for Emergency Care: The intravenous formulation achieves peak efficacy in <15 minutes, and the oral formulation in <30 minutes, enabling rapid intervention against arterial thrombosis and filling the global gap in rapid antiplatelet treatment during the acute phase of stroke;
2. Potent Efficacy at Low Doses: The clinical dose is only 1% of that of clopidogrel, significantly reducing medication burden and potential safety risks;
3. Safe and Stable, Broad Applicability: It shows no significant individual variability, with extremely low risks of bleeding and drug-drug interactions, making it particularly suitable for elderly patients with multiple underlying conditions requiring combination therapy.

Dr. He Gongxin, Founder and CEO of Kejun Pharmaceuticals, stated: “The successful enrollment of the first subject in the U.S. registration clinical trial for Efugrel is a significant milestone in Kejun Pharmaceuticals’ global innovative drug R&D journey. Cardiovascular and cerebrovascular diseases are the leading cause of death and disability worldwide, and existing treatment options have significant unmet needs. With its novel mechanism and dual-formulation advantages, Efugrel has the potential to reshape the global antiplatelet treatment landscape.”

In addition to the U.S. market, Efugrel’s clinical development in China is also progressing efficiently. It has received clinical trial approval from the China National Medical Products Administration’s Center for Drug Evaluation (CDE), and the Phase II clinical trial for the ischemic stroke indication is about to commence. The product’s coordinated clinical layout in both the U.S. and Chinese markets provides strong support for subsequent simultaneous regulatory submissions and seizing global market opportunities.

The key clinical progress of Efugrel is not only a milestone for Kejun Pharmaceuticals but may also bring faster, safer, and more precise antiplatelet treatment options to hundreds of millions of cardiovascular and cerebrovascular disease patients worldwide. We look forward to this “China-originated innovative drug” benefiting patients globally at an early date, truly fulfilling the mission of “bringing benefits to patients.”