股票简称：华海药业 股票代码：600521 公告编号：临 2025-111 号 浙江华海药业股份有限公司 关于公司产品拟中选第十一批全国药品集中采购的公告 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个别及连带责任。 2025 年 10 月 27 日—10 月 28 日，浙江华海药业股份有限公司（以下简称"华海 药业"或"公司"）参加了国家组织药品联合采购办公室（以下简称"联采办"）组 织的第十一批全国药品集中采购的投标工作，公司 4 个产品拟中选本次集中采购，现 将相关情况公告如下： | 股票简称: | 华海药业 | | --- | --- | | 债券简称: | 华海转债 | 债券简称：华海转债 债券代码：110076 公司 2025 年半年度营业收入的 0.32%。 2、阿戈美拉汀片 2025 年 3 月，公司收到国家药品监督管理局核准签发的阿戈美拉汀片《药品注册 证书》。因该产品于 2025 年 3 月获批，因此截至 2025 年上半年末，公司该产品在国 内市场未产生销售。 3、尼麦角林片 | 产品名称 | 适应症 | 规格 ...

Core Viewpoint - Huahai Pharmaceutical's stock has shown mixed performance in recent months, with a year-to-date increase of 9.76% but a decline of 13.74% over the past 20 days, indicating volatility in investor sentiment and market conditions [1][2]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported a revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - Cumulatively, the company has distributed 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed over the past three years [3]. Stock Market Activity - As of October 28, Huahai Pharmaceutical's stock price was 19.34 yuan per share, with a market capitalization of 28.957 billion yuan. The stock experienced a trading volume of 224 million yuan and a turnover rate of 0.78% [1]. - The company has appeared on the "Dragon and Tiger List" twice this year, with the most recent instance on September 9, where it recorded a net buy of -531.011 million yuan [1]. Shareholder Information - As of September 19, the number of shareholders for Huahai Pharmaceutical increased by 28.47% to 67,300, while the average number of circulating shares per person decreased by 22.16% to 21,624 shares [2]. - Among the top ten circulating shareholders, China Europe Medical Health Mixed A (003095) is the third largest, holding 33.2468 million shares, an increase of 12.2339 million shares from the previous period [3].

关于获得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个别及连带责任。 浙江华海药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的卡格列净片的《药品注册证书》，现将 相关情况公告如下： 一、药品的基本情况 药品名称：卡格列净片 剂型：片剂 规格：100mg（按 C₂₄H₂₅FO₅S 计） 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 申请人：浙江华海药业股份有限公司 药品批准文号：国药准字 H20255777 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、药品其他相关情况 卡格列净片适应症：1、本品与盐酸二甲双胍联用：当单独使用盐酸二甲双胍 血糖控制不佳时，可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿 病患者的血糖控制；2、本品与盐酸二甲双胍和磺脲类药物联用：当联用盐酸二甲 双胍和磺脲类药物血糖控制不佳时，可与盐酸二甲双胍和磺脲类药物联合使用，配 合饮食和运动改 ...

转自：证券时报 人民财讯10月27日电，华海药业(600521)10月27日公告，公司于近日收到国家药品监督管理局核准签发 的卡格列净片的《药品注册证书》，本品与盐酸二甲双胍联用：当单独使用盐酸二甲双胍血糖控制不佳 时，可与盐酸二甲双胍联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制；本品与盐酸二 甲双胍和磺脲类药物联用：当联用盐酸二甲双胍和磺脲类药物血糖控制不佳时，可与盐酸二甲双胍和磺 脲类药物联合使用，配合饮食和运动改善成人2型糖尿病患者的血糖控制。 ...

华海药业公告，公司近日收到国家药监局核准签发的卡格列净片《药品注册证书》。卡格列净片主要用 于改善成人2型糖尿病患者的血糖控制。根据米内网数据预测，该药在2024年国内市场销售金额约为3.7 亿元。截至目前，公司在该药研发项目上已投入研发费用约564万元。此次注册证书的获得将进一步丰 富公司产品线，提升市场竞争力，对公司经营业绩产生积极影响。 ...

Core Points - Zhejiang Huahai Pharmaceutical Co., Ltd. will begin paying interest on its convertible bonds on November 3, 2025, for the period from November 2, 2024, to November 1, 2025 [2][13] - The total issuance amount of the convertible bonds is RMB 1.8426 billion, with a total of 18,426,000 bonds issued at a face value of RMB 100 each [3][10] - The bond has a maturity period of six years, from November 2, 2020, to November 1, 2026 [2][3] Interest Payment Details - The annual interest rate for the fifth year is set at 1.8%, resulting in a payment of RMB 1.80 per bond (including tax) [3][17] - The interest payment record date is October 31, 2025, with the interest payment date being November 3, 2025 [15][16] - The interest income for individual investors is subject to a 20% personal income tax, leading to a net payment of RMB 1.44 per bond after tax [17][18] Bond Characteristics - The bond is convertible into the company's A-shares, with an initial conversion price of RMB 34.66 per share, and the latest conversion price is RMB 33.06 per share [14] - The bond does not provide any guarantees [7] - The bond's credit rating is "AA" with a stable outlook, as assessed by Shanghai New Century Credit Rating Co., Ltd. [10][11] Payment Method - The company has appointed China Securities Depository and Clearing Corporation Limited Shanghai Branch to handle the payment and settlement of the bond interest [16] - If the company fails to transfer the interest payment on time, it will be responsible for the subsequent payment process [16] Contact Information - The company is located at 88 Xunda Road, Xunqiao Town, Linhai City, Taizhou, Zhejiang Province [19] - The underwriter and trustee for the convertible bonds is Zheshang Securities Co., Ltd. [20]

浙江华海药业股份有限公司 | | | 关于可转换公司债券 2025 年付息公告 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个别及连带责任。 重要内容提示： 浙江华海药业股份有限公司于 2020 年 11 月 2 日公开发行的可转换公司债券 (以下简称"华海转债")将于 2025 年 11 月 3 日开始支付自 2024 年 11 月 2 日至 2025 年 11 月 1 日期间的利息。根据《浙江华海药业股份有限公司公开发行可转 换公司债券募集说明书》（以下简称"《募集说明书》"）有关条款的规定，现将有 关事项公告如下： 一、华海转债发行上市概况 1、债券名称：浙江华海药业股份有限公司可转换公司债券 7、票面金额和发行价格：按面值发行，每张面值为人民币 100 元 8、债券期限：本次发行的可转换公司债券的期限为自发行之日起 6 年，即 2020 年 11 月 2 日至 2026 年 11 月 1 日。 1 可转债付息债权登记日：2025 年 10 月 31 日 可转债除息日：2025 年 11 月 3 日 可转债兑息日：2025 年 ...

Investment Rating - The report maintains a "Positive" investment rating for the pharmaceutical and biotechnology industry in China [5]. Core Insights - The ESMO conference showcased significant breakthroughs in both foreign and domestic innovative drugs, highlighting the competitive strength of Chinese pharmaceutical companies on the international stage [3][12]. - The report emphasizes the potential of domestic innovative drugs to redefine standard therapies, particularly in the context of PD-1/VEGF dual antibodies and antibody-drug conjugates (ADCs) [8][29]. Summary by Sections 1. PD-1 plus and Domestic Dual Antibodies - The PD-(L)1/VEGF dual antibody, Ivosidenib, demonstrated strong positive results in a Phase III trial for first-line treatment of advanced squamous non-small cell lung cancer (NSCLC), showing a progression-free survival (PFS) improvement of 4.2 months compared to the PD-1 group [13][16]. - SSGJ-707, a PD-1/VEGF dual antibody, showed promising results in treating microsatellite stable (MSS) colorectal cancer, with an overall response rate (ORR) of 68.7% and a disease control rate (DCR) of 98.5% [18][19]. - HB0025, another PD-L1/VEGF dual antibody, reported an ORR of 83.3% in squamous NSCLC patients, indicating strong anti-tumor efficacy [20][21]. 2. ADCs: Accelerated Breakthroughs - SKB264, an ADC, has shown significant PFS and overall survival (OS) benefits in a Phase III trial for EGFR-mutant NSCLC, with PFS HR of 0.49 and OS HR of 0.60, indicating its potential as a new standard therapy [29][30]. - In the breast cancer domain, SKB264 demonstrated an ORR of 41.5% in CDK4/6i pre-treated HR+/HER2- advanced breast cancer, significantly outperforming chemotherapy [31][32]. - The report highlights the global potential of SKB264, with ongoing studies expected to further validate its efficacy and safety profile [23][29].

Core Viewpoint - Huahai Pharmaceutical's stock has experienced a decline in recent trading sessions, with a notable drop of 21.55% over the past 20 days, indicating potential concerns regarding its financial performance and market sentiment [1][2]. Financial Performance - For the first half of 2025, Huahai Pharmaceutical reported a revenue of 4.516 billion yuan, a year-on-year decrease of 11.93%, and a net profit attributable to shareholders of 409 million yuan, down 45.30% year-on-year [2]. - The company has cumulatively distributed 2.989 billion yuan in dividends since its A-share listing, with 1.016 billion yuan distributed over the past three years [3]. Stock Market Activity - As of October 23, Huahai Pharmaceutical's stock price was 18.53 yuan per share, with a market capitalization of 27.744 billion yuan. The stock has seen a year-to-date increase of 5.16% but has declined by 6.79% in the last five trading days [1]. - The company has appeared on the "龙虎榜" (a trading board for stocks with significant trading activity) twice this year, with the most recent appearance on September 9, where it recorded a net buy of -531.01 million yuan [1]. Shareholder Information - As of September 19, the number of shareholders for Huahai Pharmaceutical increased by 28.47% to 67,300, while the average circulating shares per person decreased by 22.16% to 21,624 shares [2]. - Major shareholders include China Europe Medical Health Mixed Fund, which increased its holdings by 12.23 million shares, and Hong Kong Central Clearing Limited, which reduced its holdings by 4.92 million shares [3]. Business Overview - Huahai Pharmaceutical, established on February 28, 2001, and listed on March 4, 2003, specializes in the research, production, and sales of various dosage forms of generic drugs, biological drugs, innovative drugs, and specialty raw materials [1]. - The company's revenue composition includes 61.86% from finished drug sales, 36.75% from raw materials and intermediates, 0.78% from other sources, and 0.62% from technical services [1].

Core Insights - Levodopa is a key medication for treating Parkinson's disease, alleviating symptoms such as muscle stiffness, tremors, and slow movement. It also shows potential for treating Alzheimer's disease, chronic pain, and constipation, with broad applications in biomedical and materials science fields [1][3][4]. Industry Overview - The levodopa market has seen continuous growth in demand due to an aging population and increasing Parkinson's disease cases. The market was negatively impacted by the pandemic from 2020 to 2022, but sales began to recover in 2023, reaching 31.83 million yuan in 2024 [1][7][8]. Industry Chain - The levodopa industry chain consists of upstream suppliers of chemical raw materials and excipients, midstream research and manufacturing processes, and downstream applications in medical institutions, pharmacies, and patients. The number of Parkinson's patients significantly influences the industry's development, with over 3 million patients aged 65 and above in China [6][7]. Competitive Landscape - The global levodopa market is dominated by a few large pharmaceutical companies, such as Merck & Co. and Pfizer, while domestic companies primarily focus on generic drugs. Key players in China include Shandong Xinhua Pharmaceutical Co., Zhejiang Huahai Pharmaceutical Co., and others [8][9]. Industry Development Trends - Market demand for levodopa is expected to continue increasing due to the rising incidence of Parkinson's disease and improvements in healthcare systems in emerging countries [10]. - Technological advancements in biopharmaceuticals are likely to enhance levodopa production processes, leading to improved efficiency and product quality. Companies are expected to develop various formulations, such as sustained-release and controlled-release preparations, to enhance patient experience [11]. - The globalization of the levodopa industry presents opportunities for companies to expand into international markets, increasing brand recognition and competitiveness [12].