| | | 浙江华海药业股份有限公司 关于召开 2023 年半年度业绩说明会的公告 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。 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 2023 年 09 月 05 日(星期二) 至 09 月 11 日(星期一)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 2023 年 8 月 31 日发 布公司 2023 年半年度报告，为便于广大投资者更全面深入地了解公司 2023 年半 年度经营成果、财务状况，公司计划于 2023 年 09 月 12 日下午 16:00-17:00 举 行 2023 年半年度业绩说明会，就投资者关心的问题进行交流。 一、 说明会类型 （二） 会议召开地点：上海证券交易所上证路演中心（网址： http ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2023-101 | 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 关于制剂产品盐酸双环胺胶囊获得美国 FDA 批准文号 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"公司"）收到美国食品药品 监督管理局（以下简称"美国 FDA"）的通知，公司向美国 FDA 申报的盐酸双 环胺胶囊的新药简略申请（ANDA，即美国仿制药申请）已获得批准，现将相关 情况公告如下： 一、药品的基本情况 1、药物名称：盐酸双环胺胶囊 2、ANDA 号：217531 3、剂型：胶囊剂 4、规格：10mg 5、申请事项：ANDA（美国新药简略申请） 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物的其他相关情况 盐酸双环胺胶囊主要用于治疗功能性肠易激综 ...

Financial Performance - The company's operating revenue for the first half of 2023 reached ¥4,294,130,016.33, representing a 12.31% increase compared to ¥3,823,472,246.00 in the same period last year[18]. - The net profit attributable to shareholders of the listed company was ¥568,819,789.73, a slight increase of 0.14% from ¥567,996,952.57 in the previous year[18]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥621,855,085.17, which is a 6.58% increase from ¥583,462,815.48 in the same period last year[18]. - The net cash flow generated from operating activities was ¥890,637,394.62, showing a significant increase of 81.49% compared to ¥490,746,363.49 in the previous year[18]. - The net assets attributable to shareholders of the listed company at the end of the reporting period were ¥8,274,115,746.63, reflecting a 9.64% increase from ¥7,546,549,238.90 at the end of the previous year[18]. - The total assets of the company amounted to ¥19,549,707,237.64, which is a 7.70% increase from ¥18,151,737,482.18 at the end of the previous year[18]. - Basic earnings per share for the reporting period (January to June) remained at CNY 0.39, unchanged from the same period last year[19]. - Diluted earnings per share for the reporting period also remained at CNY 0.39, unchanged from the same period last year[19]. - The basic earnings per share after deducting non-recurring gains and losses increased by 7.50% to CNY 0.43 from CNY 0.40 in the same period last year[19]. - The weighted average return on equity decreased by 1.06 percentage points to 7.24% from 8.30% in the same period last year[19]. Research and Development - The company has over 20 projects in its biopharmaceutical pipeline, with 11 projects currently in clinical trials, including a globally innovative dual-target anti-tumor drug project[22]. - The company has established a comprehensive R&D system with global registration centers and various research platforms, enhancing its innovative capabilities[34]. - The company has submitted over 40 invention patent applications for its innovative biological drugs, with 20 projects currently under research, including 11 in clinical stages[43]. - R&D expenses accounted for 12.2% of total revenue, remaining stable compared to the previous year[45]. - The company achieved 11 new product approvals and completed 8 new product applications during the reporting period[45]. - The company has over 60 products in the pipeline and received 4 ANDA approvals in the U.S.[45]. - The company introduced 300+ core technical talents in the first half of 2023, strengthening its talent pool[48]. Market Presence and Sales - The company has a total of 79 products with ANDA approval in the U.S. market as of June 30, 2023[22]. - The company’s raw material drug business covers 106 countries and regions, with 60 raw material drug registration numbers approved by the National Medical Products Administration[23]. - The company’s sales network has expanded to cover all 31 provinces, municipalities, and autonomous regions in China[22]. - The sales revenue from the U.S. formulation business grew by 73.3% year-on-year, indicating significant market expansion efforts[42]. - The company has established a sales network covering 31 provinces and regions in China, with 50 products passing the consistency evaluation of generic drug quality and efficacy[36]. - The company has increased its self-operated export ratio, making it a key export method, particularly in Europe, the USA, Southeast Asia, and Latin America[28]. - The company has implemented a diversified sales structure and marketing model to adapt to industry trends and strategic needs, focusing on market-driven sales strategies[29]. Financial Position and Investments - The company's cash and cash equivalents increased by 40.97% to ¥1,924,457,361.33, accounting for 9.84% of total assets[52]. - The company's short-term borrowings rose by 57.98% to ¥2,206,332,638.88, reflecting increased liquidity needs[53]. - The company's inventory increased by 2.27% to ¥3,451,194,741.15, representing 17.65% of total assets[53]. - The company's total overseas assets amounted to ¥2,007,299,238.81, making up 10.27% of total assets[54]. - The company has invested a total of approximately ¥13.34 billion and $4 million in various projects, with the largest being the Huahai Pharmaceutical Project at ¥5.68 billion, which is currently 25.34% complete[57]. - The company reported a total of ¥338.07 million in new purchases of financial assets during the period[58]. - The company has ongoing projects such as the Nanyang Block Factory Project, which has seen an investment of approximately ¥900.95 million, achieving 90.09% completion[57]. Environmental and Regulatory Compliance - The company has committed to enhancing safety and environmental protection measures in compliance with increasingly stringent regulations, focusing on sustainable development and pollution control[66]. - The company has established a quality risk management system covering the entire product lifecycle to minimize risks and ensure product quality, thereby maximizing patient safety[65]. - The company has implemented an online monitoring system for pollution discharge, ensuring compliance with environmental standards[86]. - The company has completed environmental impact assessments for four projects during the reporting period, including a digital manufacturing project[88]. - The company has achieved a 10% reduction in carbon emission intensity year-on-year while increasing production capacity[96]. - The company has installed real-time monitoring facilities for wastewater and air pollutants to ensure compliance with discharge standards[96]. Corporate Governance and Management - The company did not propose any profit distribution or capital reserve increase in its recent financial report[74]. - There was a change in senior management with the resignation of the vice president, which may impact company operations[73]. - The company repurchased and canceled a total of 968,000 restricted stocks for 27 departing incentive targets as of June 9, 2023[76]. - The company has ensured that there are no non-operating fund occupations by controlling shareholders or related parties during the reporting period[101]. - There are no significant lawsuits or arbitration matters reported during the reporting period[103]. - The company has disclosed ongoing litigation related to the valsartan incident, including details of lawsuits in the United States and arbitration cases in Europe[104]. Risks and Challenges - The company faces risks in new product development due to high technical difficulty, significant upfront investment, and lengthy approval cycles, which could adversely affect the recovery of initial investments if products fail to pass registration[64]. - Fluctuations in raw material prices, influenced by geopolitical factors, could negatively impact the company's operating performance, although the company is expanding its formulation business to mitigate this risk[68]. - The company is exposed to exchange rate fluctuations due to its international operations, which could affect revenue and profit levels, but it actively manages this risk through financial tools[69]. - The company's global strategy may be impacted by geopolitical tensions and trade barriers, potentially affecting its export business[71].

浙江华海药业股份有限公司 股东大会会议议案 浙江华海药业股份有限公司 时间：2023 年 9 月 5 日下午 14 点 30 分 地点：浙江省临海市汛桥镇浙江华海药业股份有限公司行政楼高级报告厅 会议议程 2023 年第二次临时股东大会资料 股票简称：华海药业 股票代码：600521 中国·浙江·临海 二零二三年九月五日 浙江华海药业股份有限公司 股东大会会议议案 浙江华海药业股份有限公司 2023 年第二次临时股东大会会议议程 一、与会者签到 1、审议《关于延长公司向特定对象发行股票股东大会决议有效期及授权有 效期的议案》； 四、股东现场提问 五、选举大会计票人、监票人 六、投票表决，统计表决结果 七、见证律师宣读会议见证意见 八、会议结束 1 二、每一表决票分别注明该票所代表的股份数，每股为一票表决权，投票结 果按股份数判定票数。 三、大会设监票人和计票人，由计票人计票并当场宣布表决结果。 四、表决时，投同意票的，在同意栏内打"√"；投弃权票的，在弃权栏内 打"√"；投反对票的，在反对栏内打"√"。 五、不使用本次大会统一发放的表决票，或夹写规定外文字或填写模糊无法 辨认者，视为无效票，作弃权处理。在大会 ...

证券代码：600521 证券简称：华海药业 公告编号：临 2023-097 号 债券代码：110076 债券简称：华海转债 浙江华海药业股份有限公司 关于召开 2023 年第二次临时股东大会的提示性公告 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法律责任。 重要内容提示： 浙江华海药业股份有限公司（以下简称"公司"）于2023年8月16日召开第 八届董事会第十六次临时会议，会议审议通过了《关于提议召开2023年第二次 临时股东大会的议案》，公司将于2023年9月5日召开2023年第二次临时股东大 会，并已于2023年8月17日在《中国证券报》《上海证券报》《证券时报》《证 券日报》和上海证券交易所网站www.sse.com.cn上刊登了《浙江华海药业股份 有限公司关于召开2023年第二次临时股东大会的通知》。为进一步保护投资者 的合法权益，为公司股东行使股东大会表决权提供便利，现将有关事项再次提 示如下： 1 / 6 股东大会召开日期：2023年9月5日 本次股东大会采用的网络投票系统：上海证券交易所股东大会网络投票 系统 召开的日 ...

| 股票简称：华海药业 | 股票代码：600521 | 公告编号：临 | 2023-096 | 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 关于制剂产品二甲磺酸利右苯丙胺胶囊获得美国 FDA 批准 文号的公告 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"公司"）收到美国食品药品 监督管理局（以下简称"美国 FDA"）的通知，公司向美国 FDA 申报的二甲磺 酸利右苯丙胺胶囊的新药简略申请（ANDA，即美国仿制药申请）已获得正式批 准，现将相关情况公告如下： 一、药品的基本情况 1、药物名称：二甲磺酸利右苯丙胺胶囊 2、ANDA 号：216266 3、剂型：胶囊剂 4、规格：10 mg、20 mg、30 mg、40 mg、50 mg、60 mg、70 mg 5、申请事项：ANDA（美国新药简略申请） 2023 年 5 月，公司向 FDA 申报的二甲磺酸利右苯 ...

浙江天册律师事务所 关于 浙江华海药业股份有限公司 向特定对象发行 A 股股票的 补充法律意见书（三） 浙江省杭州市杭大路 1 号黄龙世纪广场 A 座 11 楼 310007 电话：0571-87901111 传真：0571-87901500 7-3-1 补充法律意见书（三） 浙江天册律师事务所 关于浙江华海药业股份有限公司 向特定对象发行 A 股股票的 补充法律意见书（三） 请发行人进一步说明:（1）本次募投项目具体生产产品情况，是现有产 品或是新增产品；若为新增产品，说明新增产品与现有业务在人员、技术、 客户等方面的关系，并结合前述情况说明本次募投项目是否属于募集资金投 编号：TCYJS2023H1290 号 7-3-2 致：浙江华海药业股份有限公司 浙江天册律师事务所（以下简称"本所"）根据上海证券交易所上市审 核中心"上证上审（再融资）〔2023〕606 号"《关于浙江华海药业股份有限 公司向特定对象发行股票申请文件的审核问询函》的要求，出具本补充法律 意见书。 《浙江天册律师事务所关于浙江华海药业股份有限公司向特定对象发行 A 股股票的法律意见书》《浙江天册律师事务所关于浙江华海药业股份有限 公司向 ...

关于浙江华海药业股份有限公司 向特定对象发行股票 申请文件的审核问询函回复 保荐机构（主承销商） 二〇二三年八月 7-1-1 上海证券交易所： 贵所于 2023 年 8 月 22 日出具的《关于浙江华海药业股份有限公司向特定对 象发行股票申请文件的审核问询函》（上证上审（再融资）[2023]606 号，以下简 称"核查函"）已收悉，浙江华海药业股份有限公司与浙商证券股份有限公司、 浙江天册律师事务所、天健会计师事务所（特殊普通合伙）等相关方本着勤勉尽 责、诚实守信的原则，对核查函所列问题逐项进行了认真核查及落实，现回复如 下，请予审核。 关于回复内容释义、格式及补充更新披露等事项的说明： 一、如无特别说明，本回复中使用的简称或专有名词与《浙江华海药业股份 有限公司向特定对象发行股票募集说明书（申报稿）》中的释义相同。在本回复 中，合计数与各分项数值相加之和在尾数上存在差异，均为四舍五入所致。 7-1-2 1、关于募投项目 根据申报材料及前次审核问询回复，1）本次募投项目包括制剂数字化智能 制造建设项目、抗病毒等特色原料药多功能生产平台和补充流动资金；2）抗病 毒等特色原料药多功能生产平台所涉及特色原料药暂未取 ...

录 一、关于财务性投资………………………………………………………………………第 1—8 页 7-2-1 关于浙江华海药业股份有限公司 申请向特定对象发行股票的审核问询函中 有关财务事项的说明 天健函〔2023〕1210 号 上海证券交易所: 由浙商证券股份有限公司转来的《关于浙江华海药业股份有限公司向特定对 象发行股票申请文件的审核问询函》(上证上审(再融资)(2023)606 号,以下 简称审核问询函>奉悉。我们已对审核问询函所提及的浙江华海药业股份有限公 司(以下简称华海药业公司或公司)财务事项进行了审慎核查,现汇报如下。 一、关于财务性投资 根据前次审核问询回复,1)2022年11月,公司以1.2亿元认购上海君实 生物医药科技股份有限公司(以下简称君实生物)新发行股份,取得君实生物 0. 23%的股权,公司的控股子公司华奥泰生物与君实生物于 2019年已经就贝伐 珠单抗(含非小细胞肺癌和结直肠癌）的后续研发、生产、上市及销售开展合作, 公司投资君实生物有助于提高公司在生物创新药领域的布局,符合公司主营业 务及战略发展方向,因此未认定为财务性投资;2) 截至 2022年12月31日, 公司对深圳市星河环境 ...

关于制剂产品坎地沙坦酯片获得美国 FDA 批准文号的公告 | 股票简称：华海药业 股票代码：600521 | 公告编号：临 | 2023-094 | 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 3、剂型：片剂 4、规格：8 mg、16mg、32mg 5、申请事项：ANDA（美国新药简略申请） 6、申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物的其他相关情况 坎地沙坦酯片主要用于治疗高血压。坎地沙坦酯片由 AstraZeneca 研发，于 1998 年 6 月在美国上市。当前，美国境内，坎地沙坦酯片主要生产商有 Alembic、 Viatris、Macleods 等。2022 年该药品美国市场销售额约 3,336.83 万美元（数据来 源于 IMS 数据库）。 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"公司"）收到美国 ...