登录新浪财经APP 搜索【信披】查看更多考评等级 为应对行业变局，东亚药业提出"原料药制剂一体化"战略，希望通过向下游制剂延伸来提升竞争力。 2024年下半年以来，公司陆续申报了十余个原料药及制剂品种，其中左氧氟沙星片已于近期获批，成为 其转型落地的首个制剂产品。 然而，转型成效远未达预期。目前仅有一个品种获批，其余大多仍在申报阶段，短期内难以形成规模贡 献。更关键的是，已获批的左氧氟沙星片属于市场竞争激烈的成熟仿制药，利润空间有限，难以支撑业 绩反转。 除此之外，公司内部治理问题也逐渐暴露。2024年10月，东亚药业因募集资金用途披露不准确、未及时 履行审议程序等问题，被上交所予以监管警示。这不仅影响公司资本市场形象，也反映出其在规范运作 和信息披露方面存在不足，可能进一步动摇投资者信心。 东亚药业的业绩压力已持续多年。数据显示，2023年至2025年前三季度，公司营业收入从13.56亿元逐 年下滑至5.96亿元，归母净利润则由盈转亏，从盈利1.21亿元转为亏损7240.96万元。尤其引人关注的 是，公司资产负债率已从2023年的39.72%攀升至2025年三季度的46.46%，财务结构风险逐渐显露。 造成 ...

1月23日，浙江东亚药业股份有限公司（简称"东亚药业"）发布2025年业绩预告，预计实现归属于上市 公司股东的净亏损为9000万元到7500万元，上年同期为净亏损1.01亿元；预计实现归属于上市公司股东 的扣除非经常性损益的净亏损为1.02亿元到8700万元，上年同期为净亏损9840.82万元。相关数据显示， 东亚药业已连续多期业绩下滑，这家老牌原料药企业究竟面临着哪些挑战？ 三大因素致业绩预亏 对于业绩预亏的原因，东亚药业在预告中表示，从收入端来看，报告期内，受国内集采降价、行业相关 政策及市场竞争加剧等因素影响，产品终端特别是头孢类产品，需求变化较大，叠加产业链各环节产能 供需变化、库存压力等影响，导致其部分产品面临需求减少的压力。上述情况导致东亚药业报告期营业 收入较上年度下滑，毛利额同比减少1.08亿元。 对此，东亚药业提出了"原料药制剂一体化"战略。2025年半年报显示，东亚药业自2024年下半年以来已 陆续申报并获得国家药监局受理头孢妥仑匹酯、拉氧头孢钠、头孢美唑钠、头孢丙烯等，其中，在报告 期内提交了盐酸头孢卡品酯、布立西坦、多奈哌齐等原料药注册申请；在制剂的仿制药业务线，重点围 绕可转债募投项 ...

证券代码：605177 证券简称：东亚药业 公告编号：2026-003 债券代码：111015 债券简称：东亚转债 浙江东亚药业股份有限公司2025年度业绩预告 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。 重要内容提示： 预计2025年度实现归属于上市公司股东的扣除非经常性损益的净利润为-10,200万元到-8,700万元。 （三）本业绩预告为公司初步测算数据，未经注册会计师审计。但公司已与会计师进行了充分沟通，在 业绩预告方面不存在重大分歧。 二、上年同期经营业绩和财务状况 ● 本次业绩预告适用情形：净利润为负值。 ● 浙江东亚药业股份有限公司（以下简称"公司"）预计2025年度实现归属于上市公司股东的净利润 为-9,000万元到-7,500万元。 ● 公司预计2025年度实现归属于上市公司股东的扣除非经常性损益的净利润为-10,200万元到-8,700万 元。 一、本期业绩预告情况 （一）业绩预告期间 2025年1月1日至2025年12月31日。 （二）业绩预告情况 经财务部门初步测算，公司预计2025年度实现归属于上 ...

报告期内，公司原料药及制剂陆续新申报了一批批件。其中获得了左氧氟沙星片的批件，为公司获批的 首个制剂批件，标志着公司原料药制剂一体化发展战略取得重大突破，将进一步丰富公司产品线，有助 于提升公司竞争力，促进公司持续、稳定、健康地发展。同时为公司后续制剂注册证书申报积累了宝贵 的经验。 东亚药业（605177）(605177.SH)发布2025年度业绩预告，预计2025年度实现归属于上市公司股东的净 亏损7,500万元至9,000万元。 ...

报告期内，公司原料药及制剂陆续新申报了一批批件。其中获得了左氧氟沙星片的批件，为公司获批的 首个制剂批件，标志着公司原料药制剂一体化发展战略取得重大突破，将进一步丰富公司产品线，有助 于提升公司竞争力，促进公司持续、稳定、健康地发展。同时为公司后续制剂注册证书申报积累了宝贵 的经验。 智通财经APP讯，东亚药业(605177.SH)发布2025年度业绩预告，预计2025年度实现归属于上市公司股 东的净亏损7,500万元至9,000万元。 ...

Core Viewpoint - The antibacterial drug market in China is under pressure, with sales expected to drop below 100 billion yuan in 2024 and continue declining by approximately 18% in the first three quarters of 2025, reaching over 60 billion yuan [1][14]. Market Performance - The total sales of systemic antibacterial drugs in public medical institutions in China have been declining, with a significant drop in sales from 2024 to 2025 [1][14]. - The market for systemic antibacterial drugs includes 12 major therapeutic categories, with cephalosporins leading but experiencing four consecutive years of sales decline from 2022 to the first three quarters of 2025 [3][16]. Company Rankings - In the ranking of major companies, Pfizer, China National Pharmaceutical Group, and North China Pharmaceutical Group hold the top three positions, with sales exceeding 6.2 billion yuan, 2.1 billion yuan, and 1.9 billion yuan respectively in the first three quarters of 2025 [5][18]. - Nanjing Youke Biological, ranked fifteenth, showed remarkable growth with a year-on-year increase of 137.17%, marking its first entry into the top 20 groups [5][18]. Product Performance - The top 20 systemic antibacterial drugs accounted for over 50% of the market share, with the leading product, injectable cefoperazone/sulbactam (2:1), achieving sales of over 4.5 billion yuan [21][22]. - Notably, the compound injection of cefoperazone/sulbactam saw a dramatic increase of 219.32%, marking a significant rise in its market presence [21][23]. National Procurement Impact - Among the top 20 products, 15 have been included in the national procurement program, with 13 experiencing double-digit declines in sales [21][23]. - The tenth batch of national procurement saw injectable piperacillin/tazobactam drop by 55.61%, while the eleventh batch saw injectable cefoperazone/sulbactam decline by 47.56% [21][23]. New Drug Development - Currently, there are no domestic class 1 new drugs among the top 20 systemic antibacterial products, although five class 1 new antibacterial drugs have been approved since 2021 [25][26]. - Eight products meet the criteria for national procurement inclusion, with seven being injectable forms and one oral formulation [25][26].

Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December compared to November [1][5]. Group 1: Drug Approval Trends - As of December 19, 2023, a total of 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling in rejections or withdrawals compared to November [1]. - The therapeutic areas affected include cardiovascular, metabolic diseases, nervous system, respiratory, anti-infection, oncology, ophthalmology, dermatology, and digestive systems, with specific drugs like sacubitril/valsartan and sitagliptin/metformin among those impacted [1]. - Multiple manufacturers faced challenges with the same drug, such as the allergy treatment bilastine, which had six companies involved in unsuccessful applications [2]. Group 2: Reasons for Rejections - Some companies, like Jiutian Pharmaceutical, have publicly stated that their withdrawal was due to the need for further data refinement after discussions with the National Drug Review Center [3]. - Manufacturers of rejected generic drugs indicated that the primary issues were related to raw materials rather than the formulations themselves [3]. Group 3: Regulatory Changes - The approval process for generic drugs is tightening, as indicated by the recent drafts of guidelines from the National Medical Products Administration, which outline significant deficiencies in pharmaceutical research and bioequivalence studies [5][6]. - The new guidelines suggest that applications with major deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [5]. Group 4: Market Dynamics - The Chinese generic drug market is facing increased competition, with a significant number of companies vying for approval of similar products, leading to market saturation [7]. - The report from the Chinese Academy of Medical Sciences indicates that by 2024, generic drugs will still account for 50% of the overall pharmaceutical market, with a notable increase in the number of approved generic varieties [7]. - The market concentration remains low, with the top ten companies holding around 22% of the market share, indicating ongoing challenges for profitability in the generic sector [7]. Group 5: Industry Insights - Industry experts have noted that the increasing number of generic drug projects, often with lower development costs compared to innovative drugs, contributes to market saturation and competition [8]. - Concerns about "internal competition" in the generic drug sector have prompted calls for regulatory adjustments to optimize the approval process and reduce unnecessary resource expenditure [8].

Core Viewpoint - Zhejiang Anglikang Pharmaceutical Co., Ltd. reported significant growth in revenue and net profit for the first three quarters of 2025, driven by product structure optimization and high-margin products [1][3]. Financial Performance - The company achieved a revenue of 1.055 billion yuan and a net profit of 77.6899 million yuan, marking a year-on-year increase of 55.59% [1]. - In Q3 alone, revenue reached 331 million yuan, up 20.67% year-on-year, with net profit soaring by 164.77% to 11.7647 million yuan [1]. Strategic Developments - Anglikang is transitioning towards a "combination of generics and innovation" model, with its innovative drug pipeline progressing well, particularly the ALK-N001 project entering Phase I clinical trials [1]. - The collaboration with Shanghai Qinhuali Biopharmaceutical Technology Co., Ltd. on the ALK-N002/IMD-1005 project enhances Anglikang's position in the oncology drug market [2]. Product Pipeline and Market Position - ALK-N002/IMD-1005 is a novel IgG1 subtype antibody targeting CD47, showing promising preclinical results in inhibiting tumor growth in specific cancer models [2]. - The partnership is expected to enrich Anglikang's product matrix in the anti-tumor innovation drug sector, boosting its competitive strength [2]. Industry Context - The pharmaceutical industry is undergoing structural adjustments and innovation upgrades, with Anglikang successfully navigating these changes through clear strategic planning [3]. - Short-term support for Anglikang's business comes from the market expansion of generic drugs like levofloxacin and effective cost control [3]. - Long-term growth potential is linked to the clinical advancement of the ALK series innovative drug projects and the realization of value from industry chain investments [3].

Core Viewpoint - The company, Anglikang, reported significant growth in revenue and net profit for the first three quarters of the year, indicating a strong recovery in its financial performance and a shift towards accelerated profitability release [1][2]. Financial Performance - For the first three quarters, Anglikang achieved a revenue of 1.006 billion yuan and a net profit attributable to shareholders of 77.69 million yuan, marking a year-on-year increase of 55.59% [1]. - In the third quarter alone, the company generated revenue of 331 million yuan, a year-on-year growth of 20.67%, and a net profit of 11.76 million yuan, which represents a substantial year-on-year increase of 165% [1]. Product Strategy - The growth in profitability is attributed to the company's ongoing product structure optimization strategy, with a continuous increase in the proportion of high-margin products, leading to a gross margin rise to 38.59%, up by 7.15 percentage points year-on-year [1]. - Anglikang is transitioning towards a "combination of generics and innovation" development model, with its innovative drug pipeline progressing well [1]. Innovation and Collaboration - The ALK-N001 project has entered Phase I clinical trials, and the company has reached an agreement with a partner for the second innovative drug project, ALK-N002/IMD-1005, further enhancing its innovative drug research and development capabilities [1][2]. - ALK-N002/IMD-1005 is a globally innovative targeted antibody drug that may provide new immunotherapy options for cancer patients, showing promising preclinical results in tumor models [2]. Market Position and Future Outlook - The partnership with the collaborator is expected to enrich the company's product matrix in the anti-tumor innovative drug field, enhancing its overall competitiveness [2]. - Anglikang's investment in its subsidiary, Haichang Bio, which plans to apply for a Hong Kong stock listing, is anticipated to inject new momentum into its development and open new paths for value growth [2]. - The current pharmaceutical industry is undergoing structural adjustments and innovation upgrades, and Anglikang's clear strategic layout positions it well for breakthroughs in this environment [2].

Core Viewpoint - Zhejiang Dongya Pharmaceutical Co., Ltd. is facing regulatory scrutiny due to discrepancies in the use of raised funds compared to what was disclosed in its IPO prospectus, leading to a warning for its former board secretary and ongoing financial challenges for the company [1][2][3]. Group 1: Regulatory Issues - Zhejiang Securities Regulatory Bureau found that Dongya Pharmaceutical's actual use of raised funds did not align with the disclosures made in its IPO prospectus, and the company failed to follow internal review procedures for these changes [2]. - The company has been ordered to rectify these issues, and the violations will be recorded in the securities market's integrity archives [2][3]. Group 2: Financial Performance - Dongya Pharmaceutical's revenue for 2022, 2023, 2024, and the first half of 2025 were reported at 1.18 billion, 1.36 billion, 1.20 billion, and 416 million respectively, with year-on-year growth rates of 65.62%, 15.00%, -11.66%, and -35.85% [4]. - The net profit attributable to shareholders for the same periods was 104 million, 121 million, -101 million, and -30.23 million, with year-on-year growth rates of 52.46%, 16.11%, -183.02%, and -193.09% [4]. - The company's debt-to-asset ratio has increased from 25.56% in 2022 to 47.70% in the first half of 2025, indicating rising financial leverage [4]. Group 3: Business Challenges - Dongya Pharmaceutical's core antibacterial drug business is under significant pressure due to the government's "antibiotic restriction orders," which have limited the market space for antibacterial drugs [5][6]. - The company has attempted to implement a "raw material drug formulation integration" strategy, but progress has been slow, with only one of over ten submitted formulations receiving approval [7]. - The existing product structure remains heavily reliant on antibacterial drugs, exposing the company to substantial market and policy risks [7].