SHENYANG XINGQI PHARMACEUTICAL CO.(300573)
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兴齐眼药:SQ-129玻璃体缓释注射液获得临床试验批准
Zhi Tong Cai Jing· 2025-10-09 08:33
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of SQ-129 vitreous sustained-release injection, a modified new drug aimed at treating diabetic macular edema and macular edema caused by retinal vein occlusion [1] Group 1: Product Development - SQ-129 vitreous sustained-release injection is classified as a chemical drug type 2.2 modified new drug [1] - The clinical application is intended for (1) treatment of diabetic macular edema (DME) in adult patients; (2) treatment of macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in adult patients [1] - The company has completed various studies, including pharmaceutical and non-clinical pharmacology and toxicology, demonstrating good safety and clinical development value for SQ-129 [1] Group 2: Market Context - Currently, there are no approved products in the domestic and international markets for SQ-129 [1]
兴齐眼药(300573.SZ):SQ-129玻璃体缓释注射液获得临床试验批准
智通财经网· 2025-10-09 08:29
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of SQ-129 vitreous sustained-release injection, which is a modified new drug in category 2.2 aimed at treating diabetic macular edema and macular edema caused by retinal vein occlusion [1] Group 1: Product Development - SQ-129 vitreous sustained-release injection is developed for treating adult patients with diabetic macular edema (DME) [1] - The injection is also intended for adult patients suffering from macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) [1] - The company has completed various studies, including pharmaceutical and non-clinical pharmacology and toxicology, demonstrating good safety and clinical development value for SQ-129 [1] Group 2: Market Context - Currently, there are no approved products in the domestic and international markets for SQ-129 vitreous sustained-release injection [1]
兴齐眼药:SQ-129玻璃体缓释注射液获得临床试验批准通知书
Di Yi Cai Jing· 2025-10-09 08:13
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of SQ-129 vitreous sustained-release injection, a new drug aimed at treating diabetic macular edema and macular edema caused by retinal vein occlusion [2]. Group 1: Product Development - SQ-129 vitreous sustained-release injection is classified as a Category 2.2 modified new chemical drug [2]. - The clinical indications for SQ-129 include treatment for adult patients with diabetic macular edema (DME) and macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) [2]. - The company has completed various studies, including pharmaceutical and non-clinical pharmacology and toxicology, demonstrating good safety and clinical development value for SQ-129 [2]. Group 2: Market Context - Currently, there are no approved products in the domestic and international markets for SQ-129 [2]. - Following the approval of the clinical trial, the company must conduct clinical research according to the approval document and obtain further approval from the National Medical Products Administration before the product can be marketed [2].
兴齐眼药(300573.SZ):SQ-129玻璃体缓释注射液获得临床试验批准通知书
Ge Long Hui A P P· 2025-10-09 08:13
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of SQ-129, a sustained-release injection for the treatment of diabetic macular edema and macular edema caused by retinal vein occlusion [1] Group 1 - The SQ-129 sustained-release injection is classified as a category 2 modified new chemical drug [1] - The clinical trial aims to treat adult patients with diabetic macular edema (DME) [1] - The clinical trial also targets adult patients with macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) [1]
兴齐眼药:SQ-129玻璃体缓释注射液获临床试验批准
Xin Lang Cai Jing· 2025-10-09 08:05
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SQ-129, a vitreous body sustained-release injection aimed at treating diabetic macular edema (DME) and macular edema caused by branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) [1] Summary by Categories Product Development - SQ-129 is classified as a Class 2 modified new chemical drug and has completed various studies including pharmaceutical and non-clinical pharmacology and toxicology, demonstrating good safety and clinical development value [1] - There are currently no approved products of this kind available in the domestic and international markets [1]
兴齐眼药(300573) - 关于SQ-129玻璃体缓释注射液获得临床试验批准通知书的公告
2025-10-09 07:58
证券代码:300573 证券简称:兴齐眼药 公告编号:2025-052 沈阳兴齐眼药股份有限公司 关于SQ-129玻璃体缓释注射液获得临床试验批准通知书 的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 近日,沈阳兴齐眼药股份有限公司(以下简称"公司")收到国家药品监督 管理局签发的关于 SQ-129 玻璃体缓释注射液的《药物临床试验批准通知书》。现 将相关情况公告如下: 一、药品基本情况 药品名称:SQ-129 玻璃体缓释注射液 适应症(1):本品适用于治疗成年患者的糖尿病性黄斑水肿(DME)。 适应症(2):本品适用于治疗成年患者中由视网膜分支静脉阻塞(BRVO)或 中央静脉阻塞(CRVO)引起的黄斑水肿。 通知书编号:2025LP02615 剂型:注射剂 申请事项:境内生产药品注册临床试验 注册分类:化学药品 2.2 类 申请人:沈阳兴齐眼药股份有限公司 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,2025 年 7 月 17 日受理的 SQ-129 玻璃体缓释注射液临床试验申请符合药品注册的有关 要求,同意开展临床试验。 通知书编 ...
兴齐眼药:9月28日召开董事会会议
Mei Ri Jing Ji Xin Wen· 2025-09-29 13:00
Company Overview - Xingqi Eye Pharmaceutical (SZ 300573) announced on September 29 that its fifth board meeting was held on September 28, 2025, discussing the revised proposal for the issuance of stocks to specific targets for the year 2025 [1] - As of the report, Xingqi Eye Pharmaceutical has a market capitalization of 15.9 billion yuan [1] Financial Performance - For the first half of 2025, the company's revenue composition was 96.15% from pharmaceutical manufacturing and 3.85% from other businesses [1]
兴齐眼药(300573) - 沈阳兴齐眼药股份有限公司2025年度向特定对象发行股票预案(修订稿)
2025-09-29 12:28
证券代码:300573 证券简称:兴齐眼药 沈阳兴齐眼药股份有限公司 SHENYANG XINGQI PHARMACEUTICAL CO., LTD. (中国(辽宁)自由贸易试验区沈阳片区新运河路 25 号) 2025 年度向特定对象发行股票预案 (修订稿) 二〇二五年九月 沈阳兴齐眼药股份有限公司 2025年度向特定对象发行股票预案 公司声明 1、公司及董事会全体成员保证本预案内容真实、准确、完整,并确认不存 在虚假记载、误导性陈述或重大遗漏,并对本预案内容的真实性、准确性、完整 性承担个别和连带的法律责任。 2、本预案按照《中华人民共和国公司法》《中华人民共和国证券法》《上市 公司证券发行注册管理办法》等法律法规及规范性文件的要求编制。 3、本次向特定对象发行股票完成后,公司经营与收益的变化由公司自行负 责,因本次向特定对象发行股票引致的投资风险由投资者自行负责。 4、本预案是公司董事会对本次向特定对象发行股票的说明,任何与之相反 的声明均属不实陈述。 5、投资者如有任何疑问,应咨询自己的股票经纪人、律师、专业会计师或 其他专业顾问。 6、本预案所述事项并不代表审批机关对于本次向特定对象发行股票相关事 项 ...
兴齐眼药(300573) - 沈阳兴齐眼药股份有限公司2025年度向特定对象发行股票募集资金使用可行性分析报告(修订稿)
2025-09-29 12:28
证券代码:300573 证券简称:兴齐眼药 沈阳兴齐眼药股份有限公司 SHENYANG XINGQI PHARMACEUTICAL CO., LTD. (中国(辽宁)自由贸易试验区沈阳片区新运河路 25 号) 2025 年度向特定对象发行股票 募集资金使用可行性分析报告 (修订稿) 二〇二五年九月 沈阳兴齐眼药股份有限公司 2025年度向特定对象发行股票募集资金使用可行性分析报告 一、募集资金使用计划 本次拟募集资金总额不超过(含)78,978.56 万元,募集资金扣除发行费用后 的净额全部用于下列项目建设,具体情况如下: 项目投资总额超出募集资金净额部分由公司以自有资金或通过其他融资方 式解决。公司董事会可根据股东会的授权,对项目的募集资金投入顺序和金额进 行适当调整。若公司在本次发行募集资金到位之前根据公司经营状况和发展规划, 对项目以自筹资金先行投入,则先行投入部分将在本次发行募集资金到位之后以 募集资金予以置换。 若实际募集资金数额少于上述项目拟投入募集资金投资金额,在最终确定的 本次募投项目范围内,公司将根据实际募集资金数额,按照项目的重要性、时效 性等情况进行调整并最终决定募集资金的具体投资项目及 ...
兴齐眼药(300573) - 关于作废部分2021年限制性股票激励计划已授予尚未归属限制性股票的公告
2025-09-29 12:28
沈阳兴齐眼药股份有限公司 关于作废部分 2021 年限制性股票激励计划 证券代码:300573 证券简称:兴齐眼药 公告编号:2025-048 已授予尚未归属限制性股票的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整,没有 虚假记载、误导性陈述或重大遗漏。 沈阳兴齐眼药股份有限公司(以下简称"公司")于 2025 年 9 月 28 日召开 了第五届董事会第十一次会议审议通过了《关于作废部分 2021 年限制性股票激 励计划已授予尚未归属限制性股票的议案》,同意根据《沈阳兴齐眼药股份有限 公司 2021 年限制性股票激励计划(草案)》(以下简称"《激励计划》")的相关规 定,对 2021 年限制性股票激励计划已授予尚未归属的 184,402 股第二类限制性 股票进行作废处理。现将相关情况说明如下: 一、本次股权激励计划已履行的相关审批程序 1、2021年8月26日,公司召开第四届董事会第五次会议,会议审议通过了《关 于〈沈阳兴齐眼药股份有限公司2021年限制性股票激励计划(草案)〉及其摘要 的议案》《关于〈沈阳兴齐眼药股份有限公司2021年限制性股票激励计划实施考 核管理办法〉的议案》《关于提请 ...