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ShanghaiMay 15, 2026 /PRNewswire/ — Shanghai Kejun Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Kejun Pharma”) recently announced that its self-developed Class 1 new drug, CG-0255 Besylate (Efugrel) capsules, has officially received approval from China’s National Medical Products Administration to conduct clinical research for the indication of ischemic stroke. This means that hundreds of millions of stroke patients worldwide are one step closer to a more efficient and stable antiplatelet therapy regimen.
Urgent Clinical Need: Significant Unmet Gaps Remain in Antiplatelet Therapy for Ischemic Stroke
Ischemic stroke (commonly known as “stroke”) is the leading cause of death and disability among adults in China, characterized by high incidence, high recurrence rates, and high disability rates. Antiplatelet therapy is the core strategy for preventing acute progression and recurrence of stroke. However, existing drugs still have numerous shortcomings:
- Clopidogrel: As the most commonly used drug in clinical practice, over 50% of patients are at risk of “clopidogrel resistance,” significantly reducing clinical efficacy and markedly increasing the risk of stroke recurrence;
- Ticagrelor: Carries a higher risk of bleeding, with limited applicable scenarios and patient populations;
- Limited Long-Term Options: Existing drugs struggle to cover the complex needs of the broad stroke patient population in terms of safety and efficacy.
Therefore, developing novel antiplatelet drugs with innovative metabolic mechanisms, stable efficacy, and excellent safety has become a critical bottleneck that clinical practice urgently needs to overcome.
CG-0255 (Efugrel): Poised to Reshape the Landscape of Antiplatelet Therapy for Stroke
CG-0255 Besylate (Efugrel) is a next-generation oral antiplatelet Class 1 new drug independently developed by Kejun Pharma, offering multiple differentiated advantages:
- Effective Overcoming of Drug Resistance: Mechanistically addresses the core clinical challenge of “clopidogrel resistance” through its metabolic pathway;
- Balance of Efficacy and Safety: Compared to existing drugs, it provides more stable antiplatelet efficacy with a better expected safety profile, achieving an optimal balance in clinical application;
- Low Dose, No Drug Interaction Risk: Clear dose-response relationship, no significant DDI risk, and overall good safety.
Dr. Hexin He, Founder of Kejun Pharma, stated:
“The approval of Efugrel capsules to advance clinical research marks a significant milestone for Kejun Pharma in the cardiovascular and cerebrovascular field. Currently, tens of millions of stroke patients worldwide are constrained by the dilemma of ‘clopidogrel resistance.’ The creation of Efugrel is precisely aimed at overcoming this global challenge. We will advance clinical development to the highest standards, striving to bring it to market as soon as possible, and build a stronger Great Wall to prevent stroke progression and recurrence for ischemic stroke patients in China and around the world.”
Clinical Outlook
With the aging of the population, stroke prevention and treatment have become a top public health priority in China. The advancement of clinical trials for Efugrel Besylate capsules is not only a key step forward in Kejun Pharma’s pipeline but also a solid footprint of Chinese innovative drug companies in addressing major unmet clinical needs.
In the future, Kejun Pharma will continue to uphold its R&D philosophy of “bringing benefits to patients and creating value for society,” accelerating the clinical development process of Efugrel to benefit the vast patient population as soon as possible.