近日，康缘药业宣布其自主研发的中药新药‘车前子片’获得国家药品监督管理局（NMPA）批准，正式进入临床试验阶段。车前子片是以传统中药材车前子为主要成分，结合现代制剂工艺开发而成的创新中药，拟用于治疗慢性前列腺炎等泌尿系统疾病。该品种在前期药理和毒理研究中已显示出良好的安全性和潜在疗效，此次获批标志着其从实验室研究迈向临床验证的关键一步。康缘药业作为国内领先的中药现代化企业，长期致力于基于经典名方和道地药材的新药研发。车前子在中医理论中具有清热利尿、渗湿通淋的功效，常用于治疗小便不利、淋浊带下等症状。公司通过现代科技手段对车前子的有效成分进行提取与优化，提升其生物利用度和治疗一致性，为患者提供更可靠、标准化的中药治疗方案。此次临床试验的启动，不仅有望填补相关疾病领域中药治疗的空白，也体现了国家对中医药创新发展的支持。未来，康缘药业将继续推进中药新药的研发进程，助力中医药高质量发展和国际化。
Recently, Kangyuan Pharmaceutical announced that its self-developed traditional Chinese medicine (TCM) new drug, ‘Plantaginis Semen Tablets’ (derived from Plantago asiatica seeds), has received approval from China’s National Medical Products Administration (NMPA) to enter clinical trials. The formulation is based on the traditional herb Plantaginis Semen, processed using modern pharmaceutical techniques, and is intended for the treatment of chronic prostatitis and other urological disorders. Preclinical pharmacological and toxicological studies have demonstrated a favorable safety profile and promising therapeutic potential, marking this regulatory approval as a critical milestone in advancing the drug from laboratory research to human clinical evaluation.As a leading enterprise in TCM modernization, Kangyuan Pharmaceutical has long focused on developing innovative drugs rooted in classical TCM formulas and authentic medicinal herbs. In traditional Chinese medicine theory, Plantaginis Semen is known for its heat-clearing, diuretic, and dampness-resolving properties, commonly used to treat symptoms such as dysuria and abnormal vaginal discharge. By leveraging modern scientific methods to extract and optimize active components, the company aims to enhance bioavailability and therapeutic consistency, offering patients a more reliable and standardized TCM treatment option.The initiation of clinical trials not only holds promise for addressing unmet needs in urological disease management with TCM but also reflects the Chinese government’s support for innovation in traditional medicine. Kangyuan Pharmaceutical remains committed to advancing the development of novel TCM products, contributing to the high-quality growth and global recognition of Chinese herbal medicine.
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