证券代码：300199 证券简称：翰宇药业 公告编号：2024-066 持有人：深圳翰宇药业股份有限公司 根据美国的联邦管理法规定，药品进入美国须向美国 FDA 申请注册并递交有关 文件，化学原料药按要求提交一份药物管理档案（DMF）。DMF 是一套有关产品生 产和质量控制方面的文件资料，主要包括生产商的成品质量标准和检验方法、生产 工艺描述、物料控制、杂质控制、稳定性以及其它质量控制方面的内容。在同品种 的市场竞争中，取得 DMF 注册登记号的企业和其产品容易被客户优先考虑，有利于 企业寻找市场机遇、开拓客户。 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没有虚假记 载、误导性陈述或重大遗漏。 2024 年 9 月 25 日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药 业"）收到美国食品药品监督管理局（FDA）的确认，公司司美格鲁肽原料药获得 DMF（Drug Master File）备案号，具体情况如下： 一、DMF 备案基本情况 原料药名称：司美格鲁肽（重组） DMF 编号：040534 类型：II 深圳翰宇药业股份有限公司 关于公司原料药获得美国 DMF 备案号的公告 二、药物 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-065 深圳翰宇药业股份有限公司 关于艾塞那肽注射液获批上市的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 近日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）收到 国家药品监督管理局下发的《药品注册证书》（受理号：CYHS2200468 、 CYHS2200469），公司"艾塞那肽注射液"获得药品注册批准，具体内容如下： 一、批件基本信息 药品名称：艾塞那肽注射液 剂型：注射剂 产品分类：化学药品 药品有效期：36 个月 上市许可持有人：深圳翰宇药业股份有限公司 审评结论：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、药品的相关情况 艾塞那肽(exenatide)为胰高血糖素样肽-1(GLP-1)类似物，用于改善 2 型糖尿病 患者的血糖控制，适用于单用二甲双胍、磺酰脲类，以及二甲双胍合用磺酰脲类， 血糖仍控制不佳的患者。 三、对公司的影响 规格：5μg（0.25mg/ml，1.2ml/支）、10μg（0. ...

证券代码：300199 证券简称：翰宇药业 深圳翰宇药业股份有限公司 投资者关系活动记录表 编号：2024-002 | --- | --- | --- | |-------------------------|--------------------------------------------------|--------------------------------------------------------------| | | □√ 特定对象调研 | □ 分析师会议 | | 投资者关系 | □ 媒体采访 □ | 业绩说明会 | | 活动类别 | □ 新闻发布会 □ | 路演活动 | | | □ 现场参观 | | | | □ 其他 （ | ） | | 参与单位名称 | United Bank of Switzerland | 、 Toronto-DominionAsset Management 、 Oddo | | 及人员姓名 | BHF 、 Grand Alliance Asset Management | 、 U Capital 、 Sumitomo Mitsui | | 时间 | DS A ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-064 深圳翰宇药业股份有限公司 关于生长抑素原料药获得CEP证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 2、药品持有人：深圳翰宇药业股份有限公司 3、发证机关：EDQM 4、证书编号：NO.CEP 2024-024-Rev 00 5、证书有效期：五年有效 二、药品的其他情况 生长抑素是人工合成的环状十四氨基酸肽，其与天然生长抑素在化学结构和作 用机理上完全相同。生理性生长抑素主要存在于丘脑下部和胃肠道。通过静脉注射 生长抑素可以：1、抑制生长激素、甲状腺刺激激素、胰岛素和胰高血糖素的分泌， 并抑制胃酸的分泌，同时还影响胃肠道的吸收、动力、内脏血流和营养功能。2、抑 制胃泌素和胃酸以及胃蛋白酶的分泌，从而治疗上消化道出血，可以明显减少内脏 器官的血流量，而又不引起体循环动脉血压的显著变化，因而在治疗食道静脉曲张 出血方面有一定的临床价值。3、抑制胰高血糖素的分泌，从而有效地治疗糖尿病酮 症酸中毒。4、生长抑素可减少胰腺的内分泌和外分泌，用以预防和治疗胰腺外科手 术后并发症。 近日， ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-062 深圳翰宇药业股份有限公司 关于公司高级管理人员辞职的公告 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）于近日收到 副总裁曾兆辉先生提交的书面辞职报告。曾兆辉先生因个人原因，申请辞去公司副 总裁一职，其辞职报告自送达公司董事会之日起生效。曾兆辉先生原定任期至第五 届董事会届满之日止，截至本公告披露日，曾兆辉先生未持有公司股份，其配偶或 其他关联人未持有本公司股份，不存在应履行而未履行的承诺事项。辞职后曾兆辉 先生将不再担任公司及子公司任何职务，其所负责的相关工作已进行良好的工作交 接，其辞职不会影响公司相关工作的正常运行。 曾兆辉先生在担任公司任职期间恪尽职守、勤勉尽责，公司及董事会对曾兆辉 先生为公司所做出的贡献表示衷心的感谢！ 特此公告。 深圳翰宇药业股份有限公司董事会 2024年8月22日 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 ...

Financial Performance - The company reported a plan not to distribute cash dividends or issue bonus shares for the fiscal year 2024[1]. - The financial report was confirmed to be true, accurate, and complete by the company's management, including the CEO and accounting head[1]. - The report period covers from January 1, 2024, to June 30, 2024[4]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion RMB for the first half of 2024, representing a 15% year-over-year growth[6]. - The company's operating revenue for the current reporting period is ¥255,720,574.14, a decrease of 21.38% compared to the same period last year, which was ¥325,278,801.43[13]. - The net profit attributable to shareholders for the current period is -¥10,358,793.27, showing an improvement of 69.65% from -¥34,133,703.88 in the previous year[13]. - The net cash flow from operating activities is ¥32,984,603.09, a significant increase of 187.58% compared to -¥37,660,161.00 in the same period last year[13]. - The gross margin for the first half of 2024 was reported at 45%, a slight improvement from 43% in the same period last year[6]. - The company reported a net profit margin of 12%, up from 10% in the previous year, indicating improved operational efficiency[165]. - The total comprehensive income for the period was reported at -¥61,816,592.37, compared to -¥38,367,804.21 in the previous year, reflecting a worsening of approximately 61.1%[134]. Product Development and Innovation - New product developments include a novel peptide nasal spray (HY3000) in collaboration with the Chinese Academy of Sciences, aimed at treating COVID-19[6]. - The company is also working on a peptide vaccine (HY3001) in partnership with the Chinese Center for Disease Control and Prevention, with plans to leverage two patents for its development[6]. - The antigen detection kit (HY3002) for COVID-19 has been developed in collaboration with Shenzhen National Infectious Diseases Clinical Medical Research Center, enhancing the company's product portfolio[6]. - The company is focusing on the development of peptide drugs, which are gaining market share due to their effectiveness and safety, particularly in the fields of immune regulation, digestive system, and anti-tumor treatments[19]. - The company has advanced automated peptide synthesis and purification systems, enhancing its production capabilities for various pharmaceutical forms[19]. - The company aims to optimize its product structure and maintain a competitive edge in the peptide raw materials and formulations market[19]. - The company has developed a range of health products, including those targeting infection, sleep aid, metabolism, and liver protection, expanding its product offerings in the health sector[23]. - The company has developed 29 peptide drugs, with 9 new drug certificates and 31 clinical approvals, establishing a strong product reserve[32]. - The company received clinical approval for the new drug Semaglutide injection in April 2024, aimed at weight management[34]. - The company completed the acquisition of a smaller competitor, which is expected to add $50 million in annual revenue[165]. Market Expansion and Strategy - The company has provided a positive outlook for the second half of 2024, projecting a revenue growth of 10% to 15%[6]. - The company is focusing on expanding its market presence in Europe and North America, targeting a 25% increase in international sales by the end of 2024[6]. - The company is actively pursuing internationalization, with a focus on overseas product registration and quality system construction, while increasing investment in clinical trials for new drugs[23]. - The company is expanding its market presence in Southeast Asia, targeting a 30% market share by the end of 2025[165]. - The company aims to leverage opportunities from domestic and international market expansions, participating in pharmaceutical exhibitions to enhance its overseas business prospects[23]. Financial Management and Investments - The company plans to invest 200 million RMB in R&D for new drug development and technology upgrades in 2024[6]. - The company has initiated a strategic acquisition of a local biotech firm to enhance its R&D capabilities and product offerings[6]. - The company has a diverse procurement model, including centralized procurement for high-volume materials, contract procurement for frequently needed items, and general procurement for other materials[27]. - The company has a total of 30 million yuan in external guarantees, with a collateral of properties in Pingshan and Dali[99]. - The company has not provided guarantees for shareholders, actual controllers, or related parties, maintaining a conservative approach to risk management[101]. Environmental and Regulatory Compliance - The company strictly adheres to various environmental protection laws and standards across its facilities, including the Guangdong Province water pollution discharge standards[68]. - The company received environmental impact assessment approvals for its headquarters and subsidiaries, with valid permits extending up to five years[69][71]. - The company has established a self-built wastewater treatment station at its Longhua headquarters, achieving "zero discharge" of production wastewater, which meets the Class III surface water standard after treatment[74]. - The company’s wastewater treatment facilities are regularly maintained and monitored, ensuring compliance with the pollutant discharge permit standards[75]. - The company has established EHS management systems at Pingshan and Wuhan branches, certified under ISO 14001 and ISO 45001[79]. Shareholder and Corporate Governance - The company emphasizes the protection of shareholder rights, ensuring fair information disclosure and treatment of all shareholders[77]. - The company maintains a strong focus on employee rights, adhering to labor laws and promoting a safe working environment[78]. - The company has implemented measures to reduce carbon emissions, although specific results were not detailed in the report[76]. - The company has not engaged in any entrusted financial management or derivative investments during the reporting period[53][54]. - The company reported no non-operating fund occupation by controlling shareholders or related parties during the reporting period[82]. Legal and Risk Management - The company is involved in a significant lawsuit related to former CEO Yuan Jiancheng, with an amount in dispute of 66.13 million yuan, currently under appeal[84]. - The company has implemented measures to mitigate risks associated with drug research and development, including a diversified product pipeline[58]. - The company has taken steps to protect its core technologies from leakage, including confidentiality agreements and competitive restrictions for key personnel[59]. - The company has not undergone any bankruptcy reorganization during the reporting period[83]. Financial Reporting and Accounting Policies - The company confirms foreign currency transactions using the spot exchange rate on the transaction date for accounting purposes[172]. - Financial assets are classified into three categories: measured at amortized cost, measured at fair value with changes recognized in other comprehensive income, and measured at fair value with changes recognized in profit or loss[174]. - The company uses the effective interest method to calculate the amortized cost of financial assets and liabilities, considering all contractual terms[174]. - The company recognizes dividend income from equity investments when the right to receive dividends is established and the amount can be reliably measured[176]. - The company assesses expected credit losses based on the weighted average of credit losses for financial instruments classified at amortized cost and those measured at fair value through other comprehensive income[183].

上市公司 2024 年半年度非经营性资金占用及其他关联资金往来 情况汇总表 | | 深圳市翰 宇创新产 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 业园运营 | 控股子公司 | 其他应收款 | 77.00 | 0.00 | 0.00 | 77.00 | 0.00 | 往来款 | 非经营性 往来 | | | 管理有限 | | | | | | | | | | | | 公司 | | | | | | | | | | | 其他关联方及其附 属企业 | - | - | - | - | - | - | - | - | - | - | | 总计 | - | - | - | 1,653.52 | 107.00 | 0.00 | 931.38 | 829.14 | - | - | 注：①表中非经营性占用部分，关联方范围依照《股票上市规则》确定。 ②无控股股东、实际控制人的公司，存在第一大股东或第一大股东关联人非经营性占用资金的，也应填写本表 非经营性占用部分。 法定代表人：曾少贵 主管会计工 ...

近日，根据 HIKMA 与公司联合获得暂定批准及最新规划备货情况，HIKMA 给 予公司确认信息，将 2024 年 2 月签订的意向采购订单转为正式订单，采购金额不 变，仍为 1,001.47 万美元，本批次订单须于 2025 年 1 月前履行完毕。 证券代码：300199 证券简称：翰宇药业 公告编号：2024-061 深圳翰宇药业股份有限公司 关于合同进展公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记 载、误导性陈述或重大遗漏。 一、背景 2024 年 2 月 6 日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药 业"）收到合作方的采购订单，其拟向公司采购金额 1,001.47 万美元（约合人民币 0.72 亿元（含税））的利拉鲁肽注射液（仿制药）。基于本事项尚需美国 FDA 出具 的利拉鲁肽注射液批件，为充分保证合作方权益，在取得利拉鲁肽批件之前，合作 方可取消或延期。具体内容详见公司于 2024 年 2 月 6 日在巨潮资讯网 （www.cninfo.com.cn）披露的《关于合同进展公告》（公告编号：2024-005）。 2024 年 6 月 25 日，公司收到美 ...

法律意见书 国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二四年第二次临时股东大会 的 北京·上海·深圳·杭州·广州·昆明·天津·成都·宁波·福州·西安·南京·南宁·济南·重庆 Beijing·Shanghai·Shenzhen·Hangzhou·Guangzhou·Kunming·Tianjin·Chengdu ·Ningbo ·Fuzhou·Xi`an·Nanjing·Nanning·Jinan·Chongqing 苏州·长沙·太原·武汉·贵阳·乌鲁木齐·郑州·石家庄·合肥·海南·青岛·南昌·大连·银川·拉孜 Suzhou·Changsha·Taiyuan·Wuhan·Guiyang·Wulumuqi·Zhengzhou·Shijiazhuang·Hefei·Hainan·Qingdao·Nanchang·Dalian·Yinchuan·Lhatse 香港·巴黎·马德里·斯德哥尔摩·纽约·马来西亚 Hongkong·Paris·Madrid·Stockholm·Newyork·Malaysia 深圳市深南大道 6008 号特区报业大厦 24、31、41、42 层 邮编：518034 24、3 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-060 深圳翰宇药业股份有限公司 2024年第二次临时股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 特别提示： 1、本次股东大会没有否决或变更议案的情况发生。 2、本次股东大会不涉及变更前次股东大会决议。 一、会议召开和出席情况 1、2024年7月19日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰 宇药业"）第五届董事会第二十八次会议审议通过《关于提请召开2024年第二次 临 时 股 东 大 会 的 议 案 》 ， 详 见 公 司 在 中 国 证 监 会 指 定 信 息 披 露 网 站 （http://www.cninfo.com.cn）披露的相关公告。 2024年第二次临时股东大会召开的基本情况如下： 会议召集人：公司董事会 2、通过现场和网络投票的股东298人，代表股份190,396,221股，占公司有表 决权股份总数的21.5565％。 其中：通过现场投票的股东7人，代表股份184,129,122股，占公司有表决权 股份总数的20.8470％。 通过网络投票的股东2 ...