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兴齐眼药近视防控产品矩阵进一步丰富 又有两款药品获准注册
Zheng Quan Ri Bao Wang· 2026-01-04 13:53
Core Viewpoint - The approval of two new specifications of atropine sulfate eye drops by the National Medical Products Administration represents a significant expansion of the company's product matrix for myopia prevention, which is expected to drive further growth in its performance [1][2]. Group 1: Product Approval and Specifications - The company received approval for two new specifications of atropine sulfate eye drops: 0.02% (0.4ml: 0.08mg) and 0.04% (0.4ml: 0.16mg) [1]. - The previously approved 0.01% (0.4ml: 0.04mg) specification is the first eye drop product approved in China for myopia-related indications [2]. - The new products are based on existing formulations and are expected to enhance the company's offerings in the myopia prevention market [2]. Group 2: Financial Performance - The company has experienced rapid growth in recent years, with a 32.42% increase in revenue and a 40.84% increase in net profit attributable to shareholders in 2024 compared to 2023 [2]. - In the first three quarters of the current year, the company's revenue grew by 32.27%, while net profit surged by 105.98% [2]. Group 3: Market Context and Future Outlook - The increasing prevalence of myopia, particularly among children and adolescents, presents a significant public health challenge and a large market opportunity for myopia prevention products [3]. - The introduction of the new products is expected to optimize the company's product matrix for myopia prevention, providing more options for patients and potentially enhancing the company's growth [3]. - The company is actively exploring different mechanisms for myopia prevention based on foundational research, indicating a commitment to expanding its product offerings in this area [3].
兴齐眼药:硫酸阿托品滴眼液药品补充申请获批 完善产品矩阵
Zhong Zheng Wang· 2026-01-04 13:11
Core Viewpoint - Xingqi Eye Pharmaceutical has received approval from the National Medical Products Administration for the supplementary application of atropine sulfate eye drops, expanding its product specifications to include 0.02% and 0.04% concentrations, which are currently not available in the domestic market [1][2] Group 1: Product Development - The new product specifications of 0.02% (0.4ml: 0.08mg) and 0.04% (0.4ml: 0.16mg) will enhance the company's product matrix, addressing the unmet needs in myopia treatment for children and adolescents [1][2] - The company has a comprehensive product line that includes treatments for myopia progression, dry eye, infections, inflammation, and glaucoma, establishing a robust portfolio in ophthalmic medications [1] Group 2: Financial Performance - For the first three quarters of 2025, the company reported a revenue of 1.904 billion yuan, reflecting a year-on-year growth of 32.27%, driven by core products like atropine [2] - The approval of the new formulations is expected to further boost the company's sales performance and market presence in the ophthalmic sector [2] Group 3: Strategic Initiatives - The company aims to enhance product accessibility and patient experience through innovative drug pipelines, differentiated product strategies, and academic promotion in the field of myopia prevention [2] - Industry experts believe that the approval of the new formulations will facilitate continuous product iteration and better meet the treatment needs for myopia in young patients [2]
1月4日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-04 10:18
Group 1 - Zhongmin Resources has completed the construction of a 30,000-ton high-purity lithium salt project, which began trial production on January 2, 2026, with a total investment of 121 million yuan [2] - Shaoyang Hydraulic's acquisition of 100% of Chongqing Xincheng Hangrui Technology has been accepted by the Shenzhen Stock Exchange [3] - Xingqi Eye Medicine received approval for the supplementary application of atropine sulfate eye drops, aimed at delaying myopia progression in children aged 6 to 12 [4] Group 2 - Bailong Oriental expects a net profit of 600 million to 700 million yuan for 2025, representing a year-on-year increase of 46.34% to 70.73% [5] - Magmite's application for a private placement has been approved by the China Securities Regulatory Commission [6] - *ST Aowei's stock may face delisting risk due to a market capitalization below 500 million yuan [7] Group 3 - Changyuan Power plans to invest 572 million yuan in a wind power project in Hubei Province, with a planned capacity of 100 MW [8] - Haizheng Pharmaceutical's shareholder intends to transfer 6.06% of the company's shares [9] - Fusheng Technology has received approval for a share issuance to acquire assets and raise matching funds [10] Group 4 - Tenglong Co. plans to establish a joint venture for a liquid cooling company with an investment of 30 million yuan [11] - *ST Tianshan reported sales of live livestock amounting to 24.6 million yuan in December 2025, with significant year-on-year growth [12] - Hengxin Oriental's controlling shareholder has released a pledge of 0.91% of shares [13] Group 5 - Peking University Pharmaceutical plans to distribute a cash dividend of 1.68 yuan per 10 shares, totaling 100 million yuan [14] - Tianlong Co. intends to acquire a 54.87% stake in Suzhou Haomi Bo for 232 million yuan [15] - Jinggong Technology's first carbon fiber production line has successfully commenced trial production [16] Group 6 - Shanfeng Cement has terminated its investment and asset acquisition plans due to disagreements on asset valuation [17] - Shengyang Co. plans to acquire 51% of Shenzhen Daren High-tech for approximately 74.47 million yuan [18] - Xinxiang Chemical has resumed production of biomass cellulose filament after equipment upgrades [19] Group 7 - Jiuding New Materials plans to invest 246 million yuan in a wind turbine blade production line project [20] - Hunan Baiyin's shareholder has reduced its stake to below 5% [21] - Century Huatong intends to repurchase shares worth 300 million to 600 million yuan [22] Group 8 - Jincai Hulin plans to acquire 51% of Wuxi Sanli for 63.43 million yuan [23] - Jiamei Packaging's stock has experienced abnormal trading fluctuations, but no significant undisclosed information has been found [25] - Guoguang Electric's general manager has resumed duties after the lifting of restrictions [26] Group 9 - Shengxing Co. is planning a private placement for 2025, with no significant changes in its operational situation [27] - *ST Meigu has applied to lift the delisting risk warning after completing its restructuring plan [28] - CATL has repurchased 15.99 million A-shares for a total of 4.386 billion yuan [29] Group 10 - Phoenix Shipping's actual controller has been released from mandatory measures [30] - Guoxin Technology's new neural network processor has successfully passed internal testing [31] - Yanjing Co. plans to acquire control of Ningbo Yongqiang Technology, leading to a stock suspension [32]
兴齐眼药(300573.SZ):硫酸阿托品滴眼液获得药品注册证书
Ge Long Hui A P P· 2026-01-04 09:28
格隆汇1月4日丨兴齐眼药(300573.SZ)公布,收到国家药品监督管理局核准签发的硫酸阿托品滴眼液 《药品补充申请批准通知书》。公司硫酸阿托品滴眼液的研发代码为SQ-729,适应症为:本品用于延 缓球镜度数为-1.00D至-4.00D(散光≤1.50D、屈光参差≤1.50D)的6至12岁儿童的近视进展。本次补充 申请是在我公司已上市硫酸阿托品滴眼液(国药准字H20243320)基础上增加两个产品规格(1) 0.02%(0.4ml:0.08mg)、(2)0.04%(0.4ml:0.16mg)。本次补充申请开展了一项关于0.02%和 0.04%阿托品滴眼液的Ⅲ期临床研究,本研究采用多中心、随机、双盲、安慰剂平行对照、优效性设计 的试验方法。研究方案中关键指标、给药周期、停药后观察期设定均参照国家药品监督管理机构最新发 布的《控制近视进展药物临床研究技术指导原则(2020年12月)》,共随机入组800例,给药期2年,停 药观察期1年,研究结果显示,0.02%和0.04%阿托品滴眼液与安慰剂相比,均能够有效延缓儿童近视进 展,且总体安全性良好。截止目前,国内外尚无0.02%和0.04%硫酸阿托品滴眼液近视相关适应症 ...
兴齐眼药硫酸阿托品滴眼液补充申请获批准
Bei Jing Shang Bao· 2026-01-04 09:23
北京商报讯(记者 丁宁)1月4日晚间,兴齐眼药(300573)发布公告称,公司收到国家药品监督管理 局核准签发的硫酸阿托品滴眼液《药品补充申请批准通知书》。 公告显示,公司硫酸阿托品滴眼液的适应症为用于延缓球镜度数为-1.00D至-4.00D(散光≤1.50D、屈光 参差≤1.50D)的6至12岁儿童的近视进展。本次补充申请是在公司已上市硫酸阿托品滴眼液基础上增加 两个产品规格0.02%(0.4ml:0.08mg)、0.04%(0.4ml:0.16mg)。 截至目前,国内外尚无0.02%和0.04%硫酸阿托品滴眼液近视相关适应症产品获批上市。国外已有同类 0.01%、0.025%硫酸阿托品滴眼液产品上市。 ...
兴齐眼药低浓度阿托品滴眼液获批新规格
Quan Jing Wang· 2026-01-04 09:14
Core Viewpoint - The announcement highlights the approval of a new low-concentration atropine eye drop by the National Medical Products Administration, which is expected to uniquely position the company in the market for myopia treatment in children aged 6-12 [1] Group 1: Product Approval - The company received approval for supplementary applications of atropine sulfate eye drops in two new concentrations: 0.02% and 0.04% [1] - The approval numbers are H20258301 and H20258302, with a validity period until March 2029 [1] Group 2: Market Position - This product is the first of its kind in China aimed at delaying the progression of myopia in children with a spherical equivalent of -1.00D to -4.00D [1] - Phase III clinical trials demonstrated that both concentrations significantly delayed myopia progression compared to a placebo, with good safety profiles [1] - Currently, there are no competing products with the same concentrations available in the domestic or international markets, indicating a potential monopoly in this niche [1]
兴齐眼药:硫酸阿托品滴眼液药补充申请获批
Mei Ri Jing Ji Xin Wen· 2026-01-04 09:14
每经AI快讯,1月4日,兴齐眼药(300573.SZ)公告称,公司收到国家药品监督管理局核准签发的硫酸阿 托品滴眼液《药品补充申请批准通知书》。该药品适用于延缓球镜度数为-1.00D至-4.00D(散光 ≤1.50D、屈光参差≤1.50D)的6至12岁儿童的近视进展。公司在已上市硫酸阿托品滴眼液基础上增加两 个产品规格,分别为0.02%(0.4ml:0.08mg)和0.04%(0.4ml:0.16mg)。研究结果显示,0.02%和 0.04%阿托品滴眼液与安慰剂相比,均能有效延缓儿童近视进展,且总体安全性良好。由于医药产品市 场销售情况可能受多种因素影响,存在不确定性,敬请投资者谨慎决策,注意投资风险。 (文章来源:每日经济新闻) ...
兴齐眼药:硫酸阿托品滴眼液获得药品补充申请批准通知书
Xin Lang Cai Jing· 2026-01-04 08:32
兴齐眼药1月4日公告,公司收到国家药品监督管理局核准签发的硫酸阿托品滴眼液《药品补充申请批准 通知书》。该药品的适应症为:本品用于延缓球镜度数为-1.00D至-4.00D( 散光 ≤1.50 D 、 屈光参差 ≤1.50 D )的6至12岁儿童的近视进展。本次补充申请是在公司已上市硫酸阿托品滴眼液基础上增加两 个产品规格(1)0.02%(0.4ml:0.08mg)、(2)0.04%(0.4ml:0.16mg)。 ...
兴齐眼药(300573) - 关于获得药品注册证书的公告
2026-01-04 08:30
证券代码:300573 证券简称:兴齐眼药 公告编号:2026-001 沈阳兴齐眼药股份有限公司 关于获得药品注册证书的公告 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。 今日,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(以下简称"国家药监局")核准签发的硫酸阿托品滴眼液《药品补充申 请批准通知书》。现将有关事宜公告如下: 一、药品基本情况 药品通用名称:硫酸阿托品滴眼液 英文名/拉丁名:Atropine Sulfate Eye Drops 注册分类:化学药品 审批结论:根据《中华人民共和国药品管理法》及相关规定,经审查,2024 年 10 月 29 日受理的硫酸阿托品滴眼液符合药品注册有关要求,同意批准本次补 充申请。 上市许可持有人、生产企业:沈阳兴齐眼药股份有限公司 药品批准文号:(1)国药准字 H20258301(2)国药准字 H20258302 药品批准文号有效期:至 2029 年 03 月 04 日 二、药品的其他相关情况 公司硫酸阿托品滴眼液的研发代码为 SQ-729,适应症为:本品用于延缓球 镜度数为-1.00D 至 ...
兴齐眼药:硫酸阿托品滴眼液药品补充申请获批
Guo Ji Jin Rong Bao· 2026-01-04 08:24
兴齐眼药公告,公司收到国家药监局核准签发的硫酸阿托品滴眼液《药品补充申请批准通知书》。药品 规格为0.02%(0.4ml:0.08mg)和0.04%(0.4ml:0.16mg),适应症为延缓6至12岁儿童近视进展。药品批准 文号有效期至2029年03月04日。 ...