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浙江海正药业股份有限公司 关于公司药品通过仿制药一致性评价的公告
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,浙江海正药业股份有限公司(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")核准签发的他克莫司胶囊《药品补充申请批准通知书》,公司药品他克莫司胶囊已通过仿制药质 量和疗效一致性评价。现就相关情况公告如下: 一、药品的基本情况 药品名称:他克莫司胶囊 剂型:胶囊剂 规格:0.5mg、1mg 注册分类:化学药品 上市许可持有人:浙江海正药业股份有限公司 生产企业:浙江海正药业股份有限公司 2024年12月5日,国家药监局受理了公司递交的他克莫司胶囊一致性评价申请。截至目前,公司针对该 药品仿制药质量和疗效一致性评价已投入约6,144.39万元人民币。 三、对上市公司影响及风险提示 根据国家相关政策,通过一致性评价的药品品种在医保支付及医疗机构采购等领域将获得更大的支持力 度,因此公司的他克莫司胶囊通过仿制药一致性评价,有利于扩大上述药品的市场份额,提升市场竞争 力。 受理号:CYHB2450594、CYHB2450593 通知书编号:2025B04548、20 ...
海正药业:关于公司药品通过仿制药一致性评价的公告
Zheng Quan Ri Bao· 2025-09-29 11:20
证券日报网讯 9月29日晚间,海正药业发布公告称,近日,公司收到国家药品监督管理局核准签发的他 克莫司胶囊《药品补充申请批准通知书》,公司药品他克莫司胶囊已通过仿制药质量和疗效一致性评 价。 (文章来源:证券日报) ...
9月29日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-29 10:45
Group 1 - Yinglian Co., Ltd. expects a net profit increase of 1531.13% to 1672.97% year-on-year for the first three quarters of 2025, with projected revenue of 1.63 billion to 1.65 billion yuan, a growth of 9.49% to 10.83% [1] - Meixin Sheng plans to reduce its shareholding by no more than 1% through centralized bidding and block trading [1] - Huayin Technology signed two sales contracts totaling 402 million yuan, with one contract for special functional materials and another for research project materials [3] Group 2 - Shen Highways reported a total toll revenue of 114 million yuan for August [5] - Dash Smart signed a contract worth 113 million yuan for a smart hospital project [7] - Tianbang Food received an administrative regulatory measure decision from the China Securities Regulatory Commission for failing to disclose information in a timely manner [8] Group 3 - Fashilong plans to invest 250 million yuan to establish a wholly-owned subsidiary focused on AI applications and cloud computing [10] - Junpu Intelligent received a government subsidy of 20 million yuan, accounting for 243.97% of its audited net profit for 2024 [11] - Longyun Co. plans to apply for a bank credit limit of 32 million yuan [12] Group 4 - Yifan Pharmaceutical's subsidiary received acceptance for a drug registration application for a medication used to lower phenylalanine levels in patients [12] - Rundu Co. received a drug registration certificate for a hypertension medication [13] - Huahai Qingke elected a new employee director and appointed a new vice president [17] Group 5 - Wanyi Technology received a government subsidy of 173,000 yuan [19] - Haizheng Pharmaceutical's tacrolimus capsules passed the consistency evaluation for generic drugs [20] - Pulaike's new veterinary vaccine received registration certification [22] Group 6 - Boguang New Materials signed a major sales contract estimated at 4.3 billion to 5 billion yuan for nickel powder products [41] - Electric Soul Network announced plans for shareholders to reduce their holdings by up to 1.63% [42] - Jin Haitong's shareholders plan to reduce their holdings by up to 3% [44]
海正药业(600267.SH):他克莫司胶囊药品通过仿制药一致性评价
Ge Long Hui A P P· 2025-09-29 08:01
格隆汇9月29日丨海正药业(600267.SH)公布,公司收到国家药品监督管理局核准签发的他克莫司胶囊 《药品补充申请批准通知书》,公司药品他克莫司胶囊已通过仿制药质量和疗效一致性评价。他克莫司 胶囊主要适用于预防肝脏或肾脏移植术后的移植物排斥反应。 ...
海正药业:公司他克莫司胶囊通过仿制药一致性评价
Xin Lang Cai Jing· 2025-09-29 07:52
海正药业9月29日公告,公司收到国家药品监督管理局核准签发的他克莫司胶囊《药品补充申请批准通 知书》,公司药品他克莫司胶囊已通过仿制药质量和疗效一致性评价。他克莫司胶囊主要适用于预防肝 脏或肾脏移植术后的移植物排斥反应。 ...
海正药业(600267.SH):他克莫司胶囊已通过仿制药质量和疗效一致性评价
智通财经网· 2025-09-29 07:43
他克莫司胶囊主要适用于预防肝脏或肾脏移植术后的移植物排斥反应。治疗肝脏或肾脏移植术后应用其 他免疫抑制药物无法控制的移植物排斥反应。原研药他克莫司胶囊由AstellasPharmaCo.Limited研发。目 前,他克莫司胶囊国内主要生产厂商有浙江海正药业股份有限公司、杭州中美华东制药有限公司等。 智通财经APP讯,海正药业(600267.SH)发布公告,近日,公司收到国家药品监督管理局(以下简称"国家 药监局")核准签发的他克莫司胶囊《药品补充申请批准通知书》,公司药品他克莫司胶囊已通过仿制药 质量和疗效一致性评价。 ...
华益泰康IPO辅导进展:投资机构派驻董事调整,新聘85后董事王进
Sou Hu Cai Jing· 2025-08-17 01:23
Core Viewpoint - Huayi Taikang Pharmaceutical Co., Ltd. is progressing with its IPO guidance, with the guidance period set from April 1, 2025, to June 30, 2025, after starting the IPO filing on January 26, 2024 [2] Company Overview - Huayi Taikang was established in June 2010, focusing on the research, development, production, and sales of complex formulations and innovative formulations, providing one-stop, international pharmaceutical R&D and customized production services [3] - The company has a registered capital of 60.048 million yuan and is legally represented by Zhu Honggang [3] Product Portfolio - The main products approved for sale include sustained-release metoprolol succinate tablets, enteric-coated paroxetine sustained-release tablets, tacrolimus capsules, enteric-coated esomeprazole magnesium capsules, and agomelatine tablets, primarily used in treating hypertension, depression, organ transplantation, digestive system, and neurological diseases [4] Financial Performance - Revenue for Huayi Taikang from 2022 to 2024 was 113 million yuan, 258 million yuan, and 308 million yuan respectively, with net profits of -40.59 million yuan, 65.64 million yuan, and 59.40 million yuan [5] - In Q1 2025, the company reported revenue of 85.24 million yuan, a year-on-year increase of 30.41%, and a net profit of 28.46 million yuan, a year-on-year increase of 175.71% [6][8] - The basic earnings per share for Q1 2025 was 0.47 yuan, compared to 0.18 yuan in the same period last year [8]
华益泰康筹备上市:70后董事长诸弘刚控制37%表决权,曾任职默沙东
Sou Hu Cai Jing· 2025-08-15 08:54
Group 1 - Huayi Taikang Pharmaceutical Co., Ltd. (Huayi Taikang) has initiated its IPO counseling process, with the counseling period set from April 1, 2025, to June 30, 2025 [3] - The counseling includes all directors, supervisors, senior management, and shareholders holding more than 5% of the shares [3] - The company has appointed Wang Jin as a new director during the counseling period [3] Group 2 - Established in June 2010, Huayi Taikang focuses on the research, production, and sales of complex and innovative formulations, providing one-stop international pharmaceutical R&D and customized production services [4] - The company has received approval for several key products, including Succinic Acid Metoprolol Sustained-Release Tablets and Tacrolimus Capsules, which are primarily used in treating hypertension, depression, organ transplants, and digestive and neurological diseases [4] - Revenue figures for Huayi Taikang from 2022 to 2024 are 113 million, 258 million, and 308 million yuan, respectively, with net profits of -40.59 million, 65.64 million, and 59.40 million yuan [4] Group 3 - In the first quarter of 2025, Huayi Taikang reported revenue of 85.24 million yuan, a year-on-year increase of 30.41%, and a net profit of 28.46 million yuan, up 175.71% [5] - The company’s basic earnings per share for the first quarter of 2025 is 0.47 yuan, compared to 0.18 yuan in the same period last year [6] - The weighted average return on equity based on net profit attributable to shareholders for the first quarter of 2025 is 7.31%, up from 4.69% in the previous year [6] Group 4 - Zhu Honggang is the controlling shareholder and actual controller of Huayi Taikang, holding a direct stake of 1.58% and controlling a total of 36.78% of the voting rights through various entities [6] - Zhu Honggang has a background in pharmaceutical sciences, holding a Ph.D. from the University of Utah, and has held various managerial positions in the pharmaceutical industry since 2003 [8]
0602脱水研报
2025-06-04 01:50
Summary of Conference Call Records Industry and Company Involvement 1. **Magnetic Sensors**: The report highlights the magnetic sensor industry, emphasizing its role as a core component in intelligent perception layers, benefiting from the growth in robotics and automotive electronics markets [1][3][5]. 2. **Pharmaceuticals**: The report discusses the pharmaceutical industry, particularly focusing on the impact of centralized procurement policies on generic drugs and the potential for performance recovery in the formulation sector [15][32]. 3. **Coal Industry**: The coal sector is analyzed, with insights into port inventory dynamics and the expected rebound in coal prices due to seasonal demand [28][29]. 4. **Gaming Industry**: The gaming industry is covered, noting the successful launch of new games and their impact on company growth [30][31]. Core Insights and Arguments Magnetic Sensors 1. **Market Growth**: The magnetic sensor market is expected to grow due to increased demand from robotics, automotive electronics, and other sectors like renewable energy and consumer electronics, with a projected market size increase from $2.9 billion in 2023 to $3.7 billion by 2029, reflecting a CAGR of 4% [6][11]. 2. **Technological Advancements**: The report details the technological evolution of magnetic sensors, with Hall effect sensors holding a 64% market share in 2024, and the rise of AMR/GMR/TMR sensors in high-end applications [4][11]. 3. **Domestic Market Potential**: There is significant room for domestic manufacturers to replace international leaders, as the current localization rate for magnetic sensor chips in China is only 25% [11][13]. Pharmaceuticals 1. **Centralized Procurement Impact**: The pharmaceutical sector has faced challenges due to centralized procurement policies, which have been in place for eight years, affecting the performance of certain companies [15][16]. 2. **Optimizing Procurement Policies**: Recent trends indicate a shift towards optimizing procurement policies, which may lead to performance recovery opportunities for companies in the formulation sector [15][20]. 3. **Long-term Cash Flow Transition**: The report suggests that the generic drug business is transitioning to a cash flow model, with a focus on stabilizing prices post-competition [25][27]. Coal Industry 1. **Inventory Dynamics**: Port inventories are decreasing due to improved demand from thermal power plants, which is expected to lead to a rebound in coal prices as seasonal demand peaks [28][29]. 2. **Investment Opportunities**: The report identifies stable dividend-paying coal companies as potential investment opportunities, particularly those with robust cash flow and growth prospects [29]. Gaming Industry 1. **Market Growth**: The gaming market in China saw a total sales scale of 27.35 billion yuan in April 2025, marking a year-on-year growth of 21.93% [30]. 2. **Successful Game Launches**: Several gaming companies have successfully launched new products, which are expected to drive further growth [30][31]. 3. **Product Pipeline**: Companies are well-positioned with a rich pipeline of upcoming games, indicating strong future growth potential [31]. Other Important Insights 1. **Market Sentiment**: The overall market sentiment is improving, particularly in the pharmaceutical sector, as companies adapt to new procurement policies [20][23]. 2. **Sector-Specific Risks**: The report highlights the risks associated with centralized procurement for generic drugs, including potential price declines and market volatility [16][18]. 3. **Technological Innovations**: The advancements in magnetic sensor technology are crucial for applications in various sectors, including industrial automation and consumer electronics [4][7]. This summary encapsulates the key points from the conference call records, providing a comprehensive overview of the discussed industries and their respective dynamics.
未知机构:脱水研报丨它是智能感知层核心器件,机器人、汽车电子等下游需求翻倍增长;集采优化政策不断出台,部分公司或出现明显的业绩预期修复—2025602-20250603
未知机构· 2025-06-03 01:55
Summary of Conference Call Records Industry or Company Involved 1. **Magnetic Sensors**: Core component in intelligent perception layer, benefiting from growth in robotics and automotive electronics [3][5][11] 2. **Pharmaceuticals**: Focus on drug formulation and the impact of centralized procurement [15][32] 3. **Coal Industry**: Insights on coal price rebound and inventory dynamics [28][29] 4. **Gaming Industry**: Performance of newly launched games and market growth [30][31] Core Points and Arguments Magnetic Sensors 1. **Market Growth**: The magnetic sensor market is expected to grow due to increased demand from robotics, automotive electronics, and other sectors like renewable energy and consumer electronics. The global market size is projected to increase from $2.9 billion in 2023 to $3.7 billion by 2029, with a CAGR of 4% [6][11]. 2. **Domestic Manufacturers**: There is significant room for domestic manufacturers to replace international leaders, as the current domestic market share is only 25% [11][13]. 3. **Technological Advancements**: The market is driven by technological evolution and diverse applications, with Hall effect sensors dominating the market with a 64% share in 2024 [4][11]. Pharmaceuticals 1. **Centralized Procurement Impact**: The pharmaceutical industry has faced challenges due to centralized procurement, which has been in place for eight years. However, recent optimization policies may lead to performance recovery for some companies [15][20]. 2. **Performance Recovery**: Companies like Huadong Medicine may see a reduction in procurement risks for several products in 2024, potentially stabilizing their sales [23][25]. 3. **Long-term Outlook**: The pharmaceutical sector is transitioning towards cash flow generation as competition increases and prices stabilize post-procurement [27]. Coal Industry 1. **Inventory Dynamics**: Recent improvements in coal inventory levels are expected to lead to a price rebound as demand increases during peak seasons [28][29]. 2. **Market Sentiment**: The coal sector is anticipated to experience valuation increases as stable high dividends become more attractive [29]. 3. **Demand Recovery**: The demand for thermal power generation is expected to turn positive, supporting coal price recovery [28]. Gaming Industry 1. **Market Growth**: The gaming market in China saw a total sales scale of 27.35 billion yuan in April 2025, a year-on-year increase of 21.93% [30]. 2. **Successful New Releases**: Several gaming companies have launched successful new products, contributing to their growth and market presence [30][31]. 3. **Future Potential**: Companies with strong product pipelines and successful launches are expected to continue growing, with notable titles set to release soon [31]. Other Important but Possibly Overlooked Content 1. **Magnetic Sensor Applications**: The sensors are crucial in various applications, including industrial automation, automotive systems, and consumer electronics, indicating a broad market potential [7][9]. 2. **Pharmaceutical Pricing Dynamics**: The long-tail effects of centralized procurement pricing governance may continue to impact the market, necessitating ongoing adjustments [18][19]. 3. **Coal Supply Constraints**: The reduction in coal production due to low prices and high-cost mines may support price stability in the coal market [28]. This summary encapsulates the key insights from the conference call records, highlighting the growth potential and challenges across multiple industries.