近日，沈阳兴齐眼药股份有限公司（简称“兴齐眼药”）宣布其自主研发的一款滴眼液新药已获得国家药品监督管理局（NMPA）的临床试验批准。该药物主要用于治疗干眼症，属于高浓度环孢素A阳离子纳米乳滴眼液，具有良好的眼部渗透性和生物利用度。干眼症是一种常见的眼表疾病，患者常表现为眼睛干涩、异物感、视力波动等症状，严重影响生活质量。目前市场上虽有多种治疗手段，但疗效有限且部分患者存在耐受性问题。兴齐眼药此次获批的滴眼液采用创新制剂技术，有望在提高疗效的同时减少不良反应。公司表示，将按照相关法规要求，尽快启动I期临床试验，以评估药物的安全性、耐受性及药代动力学特征。若后续临床研究顺利，该产品有望填补国内高浓度环孢素A滴眼液的空白，为干眼症患者提供更优治疗选择。这一进展也标志着兴齐眼药在眼科创新药研发领域迈出重要一步，进一步巩固其在国内眼科用药市场的领先地位。
Recently, Shenyang Xingqi Pharmaceutical Co., Ltd. (referred to as ‘Xingqi Pharma’) announced that a novel eye drop developed in-house has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials. The investigational drug is a high-concentration cyclosporine A cationic nanoemulsion ophthalmic solution, primarily intended for the treatment of dry eye disease—a common ocular surface disorder characterized by symptoms such as dryness, foreign body sensation, and fluctuating vision, which significantly impair patients’ quality of life. Although various treatments are currently available, their efficacy remains limited, and tolerability issues persist for some patients. Xingqi’s new formulation leverages innovative drug delivery technology to enhance ocular penetration and bioavailability, potentially offering improved therapeutic outcomes with fewer side effects. The company stated it will promptly initiate Phase I clinical trials to evaluate the drug’s safety, tolerability, and pharmacokinetic profile in accordance with regulatory requirements. If clinical development progresses successfully, this product could fill a critical gap in China’s market for high-concentration cyclosporine A eye drops and provide a superior treatment option for dry eye patients. This milestone also underscores Xingqi Pharma’s continued leadership and commitment to innovation in the ophthalmic therapeutics sector.
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