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柯君医药CG-0255注射剂获得临床试验批准,用于创新抗血小板治疗

CureGene Secures Clinical Trial Approval for CG-0255 Injection for Innovative Antiplatelet Therapy

PHARMA FOCUS ASIA 等信源发布 2024-12-13 14:06

可切换为仅中文


CureGene Pharmaceutical has received approval from China's National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) for CG-0255 Benzenesulfonate for Injection.CG-0255 is the first thiol prodrug of its kind, metabolised by widely expressed carboxylesterases, bypassing the liver enzyme system. This mechanism helps overcome common challenges such as drug resistance, reduced bioavailability, and adverse interactions.

CureGene Pharmaceutical已获得中国国家医药产品管理局(NMPA)的批准,用于注射用CG-0255苯磺酸盐的临床试验申请(CTA)。CG-0255是同类中第一种硫醇前药,由广泛表达的羧酸酯酶代谢,绕过肝酶系统。这种机制有助于克服常见的挑战,例如耐药性,生物利用度降低和不良相互作用。

The drug achieves peak efficacy in under 15 minutes and is available in both injectable and oral forms, offering flexibility for various clinical needs.This investigational antiplatelet drug, classified as a section 1.1 novel drug, marks a significant step forward in the development of CG-0255 in China following notable clinical advancements reported in the United States earlier this year.Coronary artery disease (CAD), a leading cause of death worldwide, accounts for nearly 10 million fatalities annually.

该药物在15分钟内达到峰值疗效,可注射和口服两种形式,为各种临床需求提供灵活性。这种研究性抗血小板药物被归类为第1.1节新药,标志着随着今年早些时候美国报道的显着临床进展,中国CG-0255的开发迈出了重要的一步。。

The increasing prevalence of CAD underscores the need for effective treatments to mitigate associated risks, such as heart attacks and strokes. Antiplatelet therapies play a vital role in reducing these complications by preventing blood clot formation.CG-0255, developed by CureGene, represents the next generation of antiplatelet therapies as a P2Y12 receptor antagonist.

冠心病患病率的增加强调了需要有效的治疗来减轻相关风险,如心脏病发作和中风。抗血小板治疗通过防止血栓形成在减少这些并发症方面发挥着至关重要的作用。由CureGene开发的CG-0255代表了作为P2Y12受体拮抗剂的下一代抗血小板疗法。

This novel drug, which has both intravenous and oral formulations, features a unique metabolic pathway designed to enhance its efficacy and safety profile. Phase I clinical trials conducted in the United States demonstrated promising outcomes, with findings presented at major cardiology events, including the 2023 American Heart Association (AHA) and 2024 European Society of Cardiology (ESC) annual meetings.The approved CTA focuses on the injectable formulation of.

这种新型药物具有静脉和口服制剂,具有独特的代谢途径,旨在提高其疗效和安全性。在美国进行的I期临床试验显示出有希望的结果,研究结果在主要的心脏病学活动中发表,包括2023年美国心脏协会(AHA)和2024年欧洲心脏病学会(ESC)年会。批准的CTA侧重于注射制剂。