证券时报e公司讯，九洲药业(603456)10月31日晚间公告，控股子公司康川济医药收到国家药监局核准 签发的盐酸多巴胺注射液的《药品注册证书》。 盐酸多巴胺注射液，适用于心肌梗死、创伤、内毒素败血症、心脏手术、肾功能衰竭、充血性心力衰竭 等引起的休克综合征；补充血容量后休克仍不能纠正者，尤其有少尿及周围血管阻力正常或较低的休 克。 ...

证券代码：603456 证券简称：九洲药业 公告编号：2024-077 浙江九洲药业股份有限公司 关于控股子公司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法律责任。 剂型：注射剂 规格：2.5ml：50mg 申请事项：药品注册（境内生产） 注册分类：化学药品 3 类 批准文号：国药准字 H20249144 上市许可持有人：南京康川济医药科技有限公司 上市许可持有人地址：南京市江宁区文芳路 199 号 5 幢二层（江宁高新园） 近日，浙江九洲药业股份有限公司（以下简称"公司"）控股子公司南京康 川济医药科技有限公司（以下简称"康川济医药"）收到国家药品监督管理局（以 下简称"国家药监局"）核准签发的盐酸多巴胺注射液的《药品注册证书》（受理 号：CYHS2301483），具体情况如下： 一、药品的基本情况 药品名称：盐酸多巴胺注射液 三、对上市公司的影响及风险提示 本次取得盐酸多巴胺注射液的《药品注册证书》，表明康川济医药可在国内 市场生产、销售该药品，进一步丰富公司产品管线，有助于提升公司产品的市场 竞争力。上 ...

Financial Performance - In the first three quarters of 2024, the company achieved revenue of 3.965 billion CNY, a year-on-year decrease of 13.36% [3] - The net profit attributable to the parent company was 631 million CNY, down 34.74% year-on-year [3] - The company experienced a narrowing decline in quarterly revenue, with stable performance from major clients and significant growth in the formulation business [3] Business Development - The company is enhancing its R&D platform and expanding its global business by establishing wholly-owned subsidiaries in Japan and Germany [2][3] - New project numbers increased by 15% year-on-year, with over half of new projects coming from overseas, particularly in the European market [3][4] - The CDMO business showed steady growth in Q3, with expectations for continued improvement in Q4, maintaining an annual gross margin around 40% [4] Capacity and Production - The new base in Taizhou is progressing with the construction of four workshops, with a current capacity utilization rate of 30-40% [4] - The overall capacity utilization rate is below 60%, primarily affected by the specialty raw materials business [6] - The company plans to establish six peptide GMP production lines within five years, aiming for an annual production capacity of 2-3 tons of peptide products [5] Market Challenges and Strategies - The specialty raw materials segment faced significant revenue and gross margin declines due to market competition and price fluctuations [6] - The company is implementing strategic product adjustments and increasing R&D investment to enhance cost competitiveness [6] - The company is actively expanding its overseas business development team and establishing R&D platforms in the US, Japan, and Germany to drive new client acquisition [5][7] Future Outlook - The company is pursuing overseas capacity acquisitions, focusing on Europe and North America, with an expected acquisition amount not exceeding 100 million USD [7] - The formulation business is expected to maintain high growth throughout the year, supported by recent acquisitions and the establishment of a complete industry chain [7]

股 票 研 究 证 券 研 究 报 告 ——九洲药业 2024 年三季报点评 原料药承压，新业务加码推进 九洲药业(603456) [Table_Industry] 医药/必需消费 | --- | --- | --- | --- | --- | --- | |----------|-----------------------------------|-----------------------|-------|-------|-------| | | | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 吴晗 ( 分析师 ) | | | | | | 0755-23976735 | 010-83939773 | | | | | | dingdan@gtjas.com | wuhan024878@gtjas.com | | | | | 登记编号 | S0880514030001 | S0880523080005 | | | | 本报告导读： 原料药短期承压，制剂布局加快，多肽等新兴业务加码布局，业绩增长可期。 投资要点： [Table_Summary] 维持"增持"评级。202 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company is experiencing temporary pressure on its Q3 performance, with a focus on actively advancing new business areas [3] - Despite a decline in revenue and net profit, the company's CDMO business remains stable, and the rapid development of its peptide business is expected to contribute to new revenue growth [3] Financial Performance Summary - For the first three quarters of 2024, the company achieved revenue of 3.965 billion yuan, a year-on-year decline of 13.36%; net profit attributable to shareholders was 631 million yuan, down 34.74% year-on-year; and net profit excluding non-recurring items was 618 million yuan, down 35.04% year-on-year [3] - In Q3 alone, revenue was 1.201 billion yuan, a year-on-year decline of 9.15% and a quarter-on-quarter decline of 6.79%; net profit attributable to shareholders was 156 million yuan, down 54.80% year-on-year and 34.56% quarter-on-quarter [3] - The company has adjusted its profit forecast for 2024-2026, expecting net profits of 854 million, 972 million, and 1.181 billion yuan respectively, with corresponding EPS of 0.95, 1.08, and 1.31 yuan [3] Business Development Summary - The company's raw material CDMO project pipeline is steadily growing, with a 14% year-on-year increase in new projects in H1 2024, totaling 1,103 projects by the end of June 2024 [4] - The company is actively expanding its formulation CDMO business, serving over 60 clients with more than 100 formulation projects, and has seen a project number increase of approximately 32% year-on-year, with revenue growth exceeding 50% [4] - The establishment of the TIDES division in H1 2024 aims to accelerate the development of new business areas, particularly in peptide-conjugated drug technology [5]

证券代码：603456 证券简称：九洲药业 公告编号：2024-076 浙江九洲药业股份有限公司 关于公司通过美国 FDA 现场检查的公告 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。 一、美国 FDA 现场检查的相关情况 检查结果：以 NAI（无行动指示）的结果顺利通过 二、对公司的影响及风险提示 浙江九洲药业股份有限公司（以下简称"公司"）外沙厂区于 2024 年 8 月 19日至2024年8月23日期间接受了美国食品药品监督管理局（以下简称"FDA"） 的 cGMP（现行药品生产质量管理规范）现场检查，检查范围涵盖质量体系、物 料、生产、包装与标签、设备设施、实验室控制六大系统。近日，公司收到美国 FDA 签发的现场检查报告（EIR，Establishment Inspection Report），该报告表明 公司外沙厂区已通过本次 cGMP 现场检查，现将相关情况公告如下： 公司名称：浙江九洲药业股份有限公司 检查地点：浙江省台州市椒江区外沙路 99 号 检查范围：公司外沙厂区涉及原料药产品（磺胺二甲氧嘧啶、磺胺二甲 ...

九洲药业：公司通过美国FDA现场检查 财联社10月25日电，九洲药业公告，公司外沙厂区于2024年8月 19日至8月23日期间接受了美国FDA的cGMP现场检查，检查范围涵盖质量体系、物料、生产、包装与 标签、设备设施、实验室控制六大系统。 近日，公司收到美国FDA签发的现场检查报告，该报告表明公司外沙厂区已通过本次cGMP现场检查。 本次通过美国FDA现场检查，表明公司外沙厂区在药品cGMP管理体系和生产环境设施等方面符合美国 FDA要求，为公司持续拓展国际市场提供了坚实的保障，并对拓展全球规范市场带来积极影响。 查看公告原文 ...

Financial Performance - The company's operating revenue for Q3 2024 was CNY 1,200,981,402.86, a decrease of 9.15% compared to CNY 1,321,966,893.34 in the same period last year[1]. - Net profit attributable to shareholders for Q3 2024 was CNY 155,888,065.39, down 54.80% from CNY 345,043,114.27 year-on-year[1]. - The basic earnings per share for Q3 2024 was CNY 0.17, a decline of 58.54% compared to CNY 0.41 in the same period last year[4]. - Total operating revenue for the first three quarters of 2024 was CNY 3,965,261,223.17, a decrease of 13.4% compared to CNY 4,576,609,415.43 in the same period of 2023[16]. - Net profit for the first three quarters of 2024 was CNY 632,852,491.81, a decline of 34.4% from CNY 964,411,448.85 in the same period of 2023[17]. - The total comprehensive income for the first three quarters of 2024 was CNY 628.98 million, compared to CNY 970.20 million in the same period of 2023, a decrease of approximately 35.2%[18]. - The company's total comprehensive income attributable to shareholders was CNY 627.01 million for the first three quarters of 2024, down from CNY 972.55 million in the same period of 2023, a decrease of about 35.5%[18]. Assets and Liabilities - The company's total assets at the end of the reporting period were CNY 11,008,581,078.46, an increase of 1.44% from CNY 10,851,987,356.69 at the end of the previous year[4]. - The company's total liabilities amounted to CNY 2,385,504,566.85 in Q3 2024, an increase from CNY 2,318,916,463.48 in Q3 2023, reflecting a rise of 2.9%[14]. - The equity attributable to shareholders of the parent company rose to CNY 8,549,162,888.63 in Q3 2024, compared to CNY 8,461,133,056.22 in Q3 2023, an increase of 1.0%[15]. - Long-term equity investments decreased to CNY 31,475,203.17 in Q3 2024 from CNY 55,704,833.79 in Q3 2023, a decline of 43.5%[14]. Cash Flow - The net cash flow from operating activities for the year-to-date was CNY 654,028,177.61, a decrease of 42.89% compared to CNY 1,145,267,855.24 in the same period last year[4]. - The net cash flow from operating activities for the year-to-date period decreased by 42.89%, mainly due to a reduction in received payments[8]. - Net cash flow from operating activities for the first three quarters of 2024 was CNY 3.29 billion, down from CNY 3.42 billion in 2023, indicating a decrease of approximately 3.8%[19]. - The net cash flow from investing activities was -CNY 747.14 million for the first three quarters of 2024, compared to -CNY 751.36 million in the same period of 2023, showing a slight improvement[20]. - The company reported a net cash outflow from financing activities of -CNY 477.78 million in the first three quarters of 2024, contrasting with a net inflow of CNY 2.71 billion in the same period of 2023[20]. - Cash and cash equivalents at the end of the third quarter of 2024 stood at CNY 2.50 billion, down from CNY 3.79 billion at the end of the third quarter of 2023, a decrease of approximately 34.1%[20]. Strategic Initiatives - The company plans to strengthen cooperation with key clients and expand its customer base to increase order volume[4]. - The company aims to enhance its R&D capabilities and accelerate global business expansion by establishing wholly-owned subsidiaries in Japan and Germany[4]. - The company will continue to focus on technology-driven growth and the rapid development of emerging businesses[4]. - Research and development expenses for the first three quarters of 2024 were CNY 240,137,612.13, slightly up from CNY 239,837,436.31 in 2023, indicating a stable investment in innovation[16]. - The company completed the deregistration of its subsidiary, Zhejiang Raybow Life Science Technology Co., Ltd., on September 2, 2024[10]. - A new wholly-owned subsidiary in Singapore was established on August 15, 2023, and renamed Jiuzhou Pharmaceutical (Singapore) PTE. LTD. on September 12, 2024[11]. - The company signed a share transfer agreement with Fangda Pharmaceutical Technology (Shanghai) Co., Ltd. for a 25% stake in Fangda Suzhou, with a transaction price of RMB 19.6 million[12]. Shareholder Information - The total number of common shareholders at the end of the reporting period was 48,424[9]. - Zhejiang Zhongbei Jiuzhou Group Co., Ltd. held 31.52% of the shares, making it the largest shareholder[9].

投资者可于 2024 年 10 月 18 日（星期五）至 10 月 24 日（星期四）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 （603456@jiuzhoupharma.com）进行提问，公司将在信息披露允许的范围内对投 资者普遍关注的问题进行回答。 一、说明会类型 证券代码：603456 证券简称：九洲药业 公告编号：2024-075 浙江九洲药业股份有限公司 关于召开 2024 年第三季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： 会议召开地点： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com/） 浙江九洲药业股份有限公司（以下简称"公司"）将于 2024 年 10 月 25 日在 上海证券交易所网站（www.sse.com.cn）披露公司 2024 年第三季度报告。为便于 广大投资者更全面、深入地了解公司业绩和经营情况，公司计划于 2024 年 10 月 25 日（星期五） ...

证券代码：603456 证券简称：九洲药业 公告编号：2024-074 浙江九洲药业股份有限公司 关于设立德国全资孙公司的进展公告 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。 2024 年 5 月 22 日，浙江九洲药业股份有限公司（以下简称"公司"）第八 届董事会第六次会议审议通过了《关于在德国设立全资孙公司的议案》，具体内 容详见公司于 2024 年 5 月 23 日在《上海证券报》和上海证券交易所网站 （www.sse.com.cn）披露的《浙江九洲药业股份有限公司关于在德国设立全资孙 公司的公告》（公告编号：2024-043）。 近日，公司已完成德国全资孙公司的设立工作，并取得弗莱堡地方法院颁发 的注册登记证明文件，相关信息如下： 1、公司名称：Jiuzhou Pharma Europe GmbH（九洲药业欧洲有限公司） 6、经营范围：支持新药、医药品开发的相关业务；CRO 有关的受托业务； 专利权等知识产权的调查；目标化合物制造方法的研究及生产相关欧洲业务；化 合物合成工艺的开发及受托相关欧洲业务；化合物的分析和 ...