浙江华海药业股份有限公司 关于子公司药品上市许可申请获得受理的提示性公告 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。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）下属全 资子公司浙江华海生物科技有限公司（以下简称"华海生物"）收到国家药品监督管 理局（以下简称"国家药监局"）核准签发的阿达木单抗注射液（以下简称"HOT-3010 闲康乐®"）境内生产药品注册上市许可申请的《受理通知书》。现将相关情况公告如 下： 债券简称：华海转债 债券代码：110076 股票简称：华海药业 股票代码：600521 公告编号：临 2024-121 号 申请人：浙江华海生物科技有限公司 结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查，决定予 以受理。 二、药物的其他相关情况 一、药物基本情况 药物名称：阿达木单抗注射液 申报适应症：类风湿关节炎；强直性脊柱炎；银屑病；克罗恩病；葡萄膜炎；多 关节型幼年特发性关节炎；儿童斑块状银屑病；儿童克罗恩病 剂型：注射剂 规格：0.8ml:40mg 注册分类：治疗 ...

浙江华海药业股份有限公司 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"）核准签发的二甲双胍恩格列净片（I）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：二甲双胍恩格列净片（I） | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-120 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 剂型：片剂 规格：每片含盐酸二甲双胍 500mg 与恩格列净 5mg 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 2024 年 9 月，公司获得国家药监局核准签发的二甲双胍恩格列净片（V）、二 甲双胍恩格列净片（VI）的《药品注册证书》，具体内容详见公司于 2024 年 9 月 26 日刊登在中国证券报、上海 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-119 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 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"）核准签发的达格列净片的《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：达格列净片 剂型：片剂 规格：5mg、10mg（以 C21H25ClO6 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 H20249659、国药准字 H20249660 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 二、药品其他相关情况 浙江华海药业股份有限公司 董 事 会 二零二四年十二月四日 ...

一、药品的基本情况 药品名称：甲氨蝶呤注射液 | 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-118 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 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"）核准签发的甲氨蝶呤注射液的《药品注册证书》， 现将相关情况公告如下： 剂型：注射剂 规格：10ml:1g 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 H20249374 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 甲氨蝶呤注射液具有广谱抗肿瘤活性，可单独使用或与其它化疗药物联 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2024-117 | 号 | | --- | --- | --- | --- | --- | | 债券简称：华海转债 | 债券代码：110076 | | | | 浙江华海药业股份有限公司 二、药品其他相关情况 本次获批的产品主要用于适合接受利格列汀和二甲双胍治疗的 2 型糖尿病成 年患者，用于改善这些患者的血糖控制水平。该产品最早由勃林格殷格翰公司研发， 于 2012 年 1 月在美国上市，国内于 2017 年 3 月批准上市。目前国内获得该药品注 册证书的生产厂家主要有齐鲁制药有限公司、广东东阳光药业股份有限公司。根据 米内网数据预测，利格列汀二甲双胍片剂产品 2024 年上半年国内市场销售金额约 人民币 4,141 万元。 截止目前，公司在利格列汀二甲双胍片（Ⅱ）国内研发项目上已投入研发费用 约人民币 886 万元。 1 三、对公司的影响 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 ...

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： https://roadshow.sseinfo.com/）； 会议召开方式：上证路演中心网络互动； 投资者可于 2024 年 11 月 13 日(星期三) 至 11 月 19 日(星期二)16:00 前登 录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 600521@huahaipharm.com 进行提问。公司将在说明会上对投资者普遍关注的问 题进行回答。 浙江华海药业股份有限公司（以下简称"公司"）已于 2024 年 10 月 31 日发 布公司 2024 年第三季度报告，为便于广大投资者更全面深入地了解公司 2024 年第三季度经营成果、财务状况，公司计划于 2024 年 11 月 20 日 15:00-16:00 举行 2024 年第三季度业绩说明会，就投资者关心的问题进行交流。 | 证券简称：华海药业 | 证券代码：600521 | 公告编号： | 临 | 2024-116 | 号 | | --- | --- | --- | --- | - ...

Investment Rating - The report maintains a "Buy" rating for the company [3][4]. Core Views - The company has shown improved profitability through quality enhancement and lean management, with a revenue of 7.248 billion yuan for Q1-Q3 2024, representing a 16.76% increase year-on-year, and a net profit of 1.031 billion yuan, up 42.92% [3]. - The gross margin for Q1-Q3 2024 is 62.66%, an increase of 3.7 percentage points year-on-year, with Q3 gross margin at 64.26%, up 7.93 percentage points year-on-year [3]. - The company is accelerating its research and development in biopharmaceuticals and innovative drugs, with over 120 projects in progress and 70 domestic registration approvals [3]. Financial Summary - For Q3 2024, the company reported a revenue of 2.119 billion yuan, a 10.76% increase year-on-year, and a net profit of 283 million yuan, up 85.09% [3]. - The EPS forecast for 2024-2026 is set at 0.90, 1.10, and 1.33 yuan respectively, with a target price of 22.50 yuan based on a PE of 21X for 2025 [3][4]. - The company’s total market capitalization is 27.208 billion yuan, with a current price of 18.55 yuan [5]. Research and Development - The company has over 120 projects under research, with significant progress in biopharmaceuticals, including 20 projects in various clinical stages [3]. - Key clinical trials include HB0034, a monoclonal antibody targeting IL-36R, and HB0017, targeting IL-17A, both showing promising results [3]. Sales and Expenses - The sales expense ratio for Q1-Q3 2024 is 18.61%, an increase of 2.91 percentage points year-on-year, while the management expense ratio decreased to 13.67% [3]. - The net profit margin reached 14.31%, an increase of 2.82 percentage points year-on-year, driven by improved gross margins and optimized expenses [3]. Market Position - The company is positioned in the pharmaceutical industry, focusing on essential consumer goods, with a strong emphasis on innovative drug development and market expansion [4].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has experienced rapid growth in the first three quarters of 2024, with a strong performance in its domestic formulation business. Revenue reached 7.248 billion yuan, representing a year-on-year increase of 16.76%. The net profit attributable to shareholders was 1.031 billion yuan, up 42.92% year-on-year [4] - The company maintains a positive long-term outlook, with profit forecasts for 2024-2026 projected at 1.304 billion yuan, 1.555 billion yuan, and 1.929 billion yuan respectively. The current stock price corresponds to a PE ratio of 20.8, 17.4, and 14.0 for the respective years [4] Financial Summary and Valuation Indicators - For the first three quarters of 2024, the company achieved revenue of 7.248 billion yuan (up 16.76% year-on-year) and a net profit of 1.031 billion yuan (up 42.92% year-on-year). The gross margin was 62.066% (up 3.7 percentage points), and the net margin was 14.31% (up 2.82 percentage points) [4] - In Q3 2024, revenue was 2.119 billion yuan (up 10.76% year-on-year), with a net profit of 283 million yuan (up 85.09% year-on-year) [4] - The company has over 70 formulation products registered in China and more than 120 projects in development, with significant progress in its pipeline [6] Sales and Expense Ratios - The sales expense ratio for the first three quarters of 2024 was 18.61%, an increase of 2.91 percentage points year-on-year. The management expense ratio was 13.67%, down 0.93 percentage points year-on-year [5] - In Q3 2024, the sales expense ratio was 16.13%, reflecting a year-on-year increase of 3.28 percentage points [5] Research and Development Progress - The company has made significant advancements in its R&D projects, with over 120 projects currently in development and nearly 100 ANDA approvals in the U.S. [6]

Investment Rating - The report maintains a "Strong Buy" rating for Huahai Pharmaceutical (600521) with a target price of 27.4 CNY [1][2]. Core Views - The company's performance in the first three quarters of 2024 met expectations, with revenue reaching 7.248 billion CNY (+16.76%) and net profit attributable to shareholders at 1.031 billion CNY (+42.92%) [1]. - The raw material drug segment is recovering with existing products and new product launches, leading to a stable growth trajectory [2]. - Domestic formulation business is a strong growth driver, with revenue of 2.81 billion CNY (+31%) in the first three quarters of 2024 [2]. - The overseas formulation segment is stable, with revenue of 1.03 billion CNY in the same period, showing improved profitability [2]. - The forecast for net profit attributable to shareholders for 2024-2026 is 1.301 billion CNY, 1.607 billion CNY, and 1.993 billion CNY, representing year-on-year growth of 56.7%, 23.5%, and 24.0% respectively [2]. Financial Summary - Total revenue for 2023 is projected at 8.309 billion CNY, with expected growth rates of 20.2% in 2024, 20.4% in 2025, and 20.2% in 2026 [3]. - Net profit for 2023 is estimated at 830 million CNY, with significant growth anticipated in the following years [3]. - Earnings per share (EPS) is expected to increase from 0.57 CNY in 2023 to 1.36 CNY by 2026 [3]. - The company’s total assets are projected to grow from 18.6 billion CNY in 2023 to 28.825 billion CNY by 2026 [6].

债券简称：华海转债 债券代码：110076 股票简称：华海药业 股票代码：600521 公告编号：临 2024-115 号 浙江华海药业股份有限公司 关于下属子公司获得药物临床试验许可的公告 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。 近日，浙江华海药业股份有限公司（以下简称"华海药业"或"公司"）的下属 子公司上海华奥泰生物药业股份有限公司（以下简称"华奥泰"）获得新西兰药品和 医疗器械安全管理局（以下简称"MEDSAFE"）、健康及残疾伦理委员会（以下简称 "HDEC"）批准，在当地开展 HB0056 注射液 I 期临床试验。现将相关情况公告如下： 一、药物基本情况 药物名称：HB0056 注射液 适应症：哮喘 剂型：注射剂 申请事项：临床试验 申请人：上海华奥泰生物药业股份有限公司 结论：同意开展临床试验 二、药物的其他相关情况 2024 年 8 月，公司下属子公司华奥泰向 MEDSAFE 及 HDEC 提交了 HB0056 注 射液的临床试验申请；近日 MEDSAFE 及 HDEC 批准华奥泰在新西兰进行 H ...