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莎普爱思:关于立他司特滴眼液Ⅲ期临床试验完成首例受试者入组的公告
Zheng Quan Ri Bao· 2025-10-24 12:26
Core Viewpoint - The company, Shapais, announced the completion of the first subject enrollment in the Phase III clinical trial for its drug, Litasite Eye Drops [2] Group 1 - The company organized the Phase III clinical trial for Litasite Eye Drops [2] - The announcement was made on the evening of October 24 [2] - The trial has successfully enrolled its first participant [2]
莎普爱思:获得盐酸奥布卡因滴眼液《药品注册证书》
Ge Long Hui· 2025-10-24 08:21
Core Viewpoint - The company Shapuaisi (603168.SH) has received the drug registration certificate for Oubukain Hydrochloride Eye Drops from the National Medical Products Administration, indicating a significant advancement in its product offerings in the ophthalmology field [1] Group 1 - The approved Oubukain Hydrochloride Eye Drops are intended for surface anesthesia in ophthalmology [1]
莎普爱思(603168.SH):立他司特滴眼液III期临床试验完成首例受试者入组
Ge Long Hui A P P· 2025-10-24 08:19
Core Viewpoint - The company has completed the enrollment of the first subject in the Phase III clinical trial for Latanoprost eye drops, aimed at evaluating its efficacy and safety in treating dry eye in the Chinese population [1] Group 1 - The Phase III clinical trial is designed as a multi-center, randomized, double-blind, placebo-controlled study [1] - The trial's primary focus is to assess the effectiveness and safety of Latanoprost eye drops in the treatment of dry eye [1] - The first subject was enrolled on October 23, 2025 [1]
莎普爱思(603168.SH):获得盐酸奥布卡因滴眼液《药品注册证书》
Ge Long Hui A P P· 2025-10-24 08:19
Core Viewpoint - The company, Shapuaisi (603168.SH), has received the drug registration certificate for Oubukain Hydrochloride Eye Drops from the National Medical Products Administration, indicating a significant advancement in its product offerings in the ophthalmology field [1] Group 1 - The approved Oubukain Hydrochloride Eye Drops are intended for surface anesthesia in ophthalmology [1]
莎普爱思(603168) - 莎普爱思关于获得盐酸奥布卡因滴眼液《药品注册证书》的公告
2025-10-24 08:15
药品批准文号:国药准字H20255752 证券代码:603168 证券简称:莎普爱思 公告编号:临 2025-059 浙江莎普爱思药业股份有限公司 关于获得盐酸奥布卡因滴眼液 《药品注册证书》的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,浙江莎普爱思药业股份有限公司(以下简称"公司"、"莎普爱思")收到 国家药品监督管理局核发的盐酸奥布卡因滴眼液的《药品注册证书》(证书编号: 2025S03202),现将有关信息公告如下: 一、《药品注册证书》主要内容 药品名称:盐酸奥布卡因滴眼液 剂型:眼用制剂 规格:0.4%(0.5ml:2mg) 注册分类:化学药品4类 上市许可持有人:浙江莎普爱思药业股份有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药 品注册的有关要求,批准注册,发给药品注册证书。 二、药品其他情况 本次获批的盐酸奥布卡因滴眼液,可用于眼科领域内的表面麻醉。 截至本公告披露日,公司针对该药品的累计研发投入约为 372.64 万元人民币。 三、对公司的影响、后续安排及风险 ...
莎普爱思(603168) - 莎普爱思关于立他司特滴眼液Ⅲ期临床试验完成首例受试者入组的公告
2025-10-24 08:15
证券代码:603168 证券简称:莎普爱思 公告编号:临 2025-060 剂型:眼用制剂 注册分类:化学药品3类 二、立他司特滴眼液临床试验相关情况 立他司特滴眼液Ⅲ期临床试验,采用多中心、随机、双盲、安慰剂平行对照 设计,评价立他司特滴眼液在中国人群中治疗干眼的有效性和安全性,已于2025 年10月23日完成首例受试者入组。 截至本公告披露日,立他司特滴眼液项目累计研发投入约1,915.15万元人民 币。 浙江莎普爱思药业股份有限公司 关于立他司特滴眼液 III 期临床试验 完成首例受试者入组的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,浙江莎普爱思药业股份有限公司(以下简称"公司")组织开展的立 他司特滴眼液III期临床试验完成首例受试者入组。具体情况如下: 一、立他司特滴眼液基本情况 药品名称:立他司特滴眼液 三、风险提示 根据中国药品注册相关的法律法规要求,药物在获得临床试验批准后,须完 成临床试验方可进行药品注册上市许可申请。 由于药物研发的特殊性,药物从临床试验到投产的周期长,环节多,易受不 可预 ...
莎普爱思:立他司特滴眼液III期临床试验完成首例受试者入组
Xin Lang Cai Jing· 2025-10-24 08:02
Core Viewpoint - The company has initiated a Phase III clinical trial for its drug, Litasan Eye Drops, aimed at treating dry eye in the Chinese population, with the first subject enrolled on October 23, 2025 [1] Group 1: Clinical Trial Details - The trial is designed as a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the drug in the target population [1] - As of the announcement date, the total research and development investment for this project has reached approximately 19.15 million yuan [1] Group 2: Development Risks - The drug development process from clinical trials to production is lengthy and involves multiple stages, which may lead to potential issues that could result in the termination of the research [1] - The company commits to providing timely updates on the progress of the trial [1]
莎普爱思:收到盐酸奥布卡因滴眼液药品注册证书
Core Viewpoint - The company received the drug registration certificate for Oubkain Hydrochloride Eye Drops from the National Medical Products Administration, indicating a significant regulatory approval for a product used in ophthalmic surface anesthesia [1] Company Summary - Shapais (603168) announced on October 24 that it has obtained the drug registration certificate for Oubkain Hydrochloride Eye Drops [1] - The eye drops are intended for use in the field of ophthalmology, specifically for surface anesthesia [1]
A股股票回购一览:17家公司披露回购进展
Mei Ri Jing Ji Xin Wen· 2025-10-15 23:43
Core Insights - On October 16, 17 companies announced a total of 17 stock repurchase updates, indicating a significant activity in the market [1] Group 1: First Disclosure of Repurchase Plans - Three companies disclosed their stock repurchase plans for the first time, with proposed repurchase amounts of up to 400 million yuan, 150 million yuan, and 100 million yuan respectively for Hengmingda, Qizhong Technology, and Kangchen Pharmaceutical [1] Group 2: Approval of Repurchase Plans by Shareholders - Five companies had their repurchase plans approved by shareholder meetings, with the highest proposed repurchase amounts being 150 million yuan for Fenghuo Communication, 70 million yuan for Shaanxi Jinye, and 10 million yuan for Youkede-W [1] Group 3: Progress of Implemented Repurchase Plans - Four companies reported on the progress of their repurchase plans, with the highest repurchase amounts being 37.86 million yuan for Jiuan Medical, 11.19 million yuan for Intercontinental Oil and Gas, and 3.09 million yuan for Jiansheng Group [1] Group 4: Completed Repurchase Plans - Five companies completed their repurchase plans, with the highest completed amounts being 797 million yuan for Zhongwei Co., 200 million yuan for Shuangta Food, and 7.5177 million yuan for Shapais [1]
浙江莎普爱思药业股份有限公司2023年股票期权与限制性股票激励计划部分限制性股票回购注销实施公告
Core Viewpoint - The company announced the repurchase and cancellation of a total of 1,798,500 restricted stocks due to the departure of four incentive recipients and unmet performance targets for the year 2024 [1][2][4]. Summary by Sections Repurchase and Cancellation Reasons - The repurchase and cancellation of restricted stocks were approved during the sixth board meeting on April 28, 2025, due to four incentive recipients leaving the company and not meeting the performance criteria for the second release period of the incentive plan [1][2][3]. Details of the Repurchase - The company will repurchase 186,000 shares from the four departing employees and an additional 1,612,500 shares due to unmet performance targets, totaling 1,798,500 shares [1][2][4]. - The repurchase price is set at 4.18 yuan per share, which may include interest from bank deposits [4]. Impact on Share Structure - Following the repurchase, the total number of shares will decrease from 375,925,005 to 374,126,505 [5]. Compliance and Legal Opinions - The board confirmed that the decision-making process and information disclosure comply with relevant laws and regulations, ensuring no harm to the rights of incentive recipients or creditors [6][8]. - Legal opinions affirm that the repurchase has obtained necessary approvals and adheres to the relevant regulations, indicating no significant impact on the company's financial performance [8].