药物名称：利拉鲁肽原料药 药物英文名称：Liraglutide 深圳翰宇药业股份有限公司 关于全资子公司利拉鲁肽原料药 获得韩国MFDS受理的公告 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"）全 资子公司翰宇药业（武汉）有限公司的利拉鲁肽原料药获得韩国食品药品安全厅 （以下简称"MFDS"）的审批受理。现将具体情况公告如下： 证券代码：300199 证券简称：翰宇药业 公告编号：2025-023 一、药物的基本情况 三、对公司的影响 利拉鲁肽原料药获得受理后仍需 MFDS 审批通过后方可上市销售，最终审 批结果尚存在不确定性。未来上市后，将有效提升公司在行业中的竞争力，有望 对公司未来的业绩增长和行业地位产生积极推动作用。 特此公告。 深圳翰宇药业股份有限公司董事会 2025 年 5 月 7 日 注册号：20250425-210-J-1880 药物生产商：翰宇药业（武汉）有限公司 二、药物的其他情况 利拉鲁肽是人胰高血糖素样肽-1（Glucagon-like peptide-1，GLP-1）的 ...

Core Viewpoint - Hanyu Pharmaceutical's subsidiary has received approval for liraglutide active pharmaceutical ingredient from the Korean Ministry of Food and Drug Safety, which is expected to enhance the company's competitiveness and positively impact future performance and industry position [1] Company Summary - Hanyu Pharmaceutical's subsidiary, Hanyu Pharmaceutical (Wuhan) Co., Ltd., has had its liraglutide active pharmaceutical ingredient approved by the Korean Food and Drug Safety [1] - Liraglutide is a GLP-1 analog with multiple physiological functions, including promoting insulin secretion in a glucose-dependent manner, protecting pancreatic beta cells, and delaying gastric emptying to reduce appetite [1] Industry Summary - The approval of liraglutide is anticipated to boost the company's competitive edge within the industry, potentially leading to growth in future performance and an improved industry standing [1]

翰宇药业（300199）公告，全资子公司翰宇武汉于近日收到《高新技术企业证书》，发证时间为2024年 12月16日，有效期为三年。翰宇武汉此前已按15%的企业所得税税率进行纳税申报及预缴，本次通过高 新技术企业的重新认定不会对公司经营业绩产生重大影响。 ...

一、基本情况 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"） 翰 宇药业（武汉）有限公司（以下简称"翰宇武汉"）收到由全国高新技术企业认 定管理工作领导小组办公室认定，湖北省科学技术厅、湖北省财政厅、国家税务 总局湖北省税务局联合颁发的《高新技术企业证书》（编号：GR202442003830）， 发证时间为 2024 年 12 月 16 日，有效期为三年。 二、对公司的影响 本次系翰宇武汉原高新技术企业证书有效期满后的重新认定。根据国家对高 新技术企业的相关税收优惠政策，翰宇武汉自通过高新技术企业重新认定起，三 年内可继续享受国家关于高新技术企业的相关税收优惠政策，即按 15%的税率 缴纳企业所得税。翰宇武汉此前已按照 15%的企业所得税税率进行纳税申报及 预缴，本次通过高新技术企业的重新认定不会对公司经营业绩产生重大影响。 证券代码：300199 证券简称：翰宇药业 公告编号：2025-022 深圳翰宇药业股份有限公司 关于全资子公司通过国家高新技术企业重新认定的公告 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。 特此公告。 深圳翰宇药业 ...

Core Viewpoint - The impact of the U.S. tariff policy on Chinese pharmaceutical companies is relatively limited, with many companies reporting normal operations and minimal effects from the tariffs [1][2][3][4][5]. Company Responses - Heng Rui Pharmaceutical stated that overseas sales account for only 2.56% of its revenue, indicating that U.S. tariffs will have a minimal impact on its business [1]. - Han Yu Pharmaceutical emphasized its diversified market layout, which mitigates risks from single market policy changes, and reported no significant impact from the tariffs [2]. - WuXi AppTec acknowledged that tariffs would have some effect but deemed it manageable, highlighting their optimized supply chain and global presence [3]. - Kang Tai Biological reported no exports to the U.S. and is focusing on markets along the Belt and Road, indicating a strategic shift to other regions [4]. - Mindray Medical confirmed that while some raw materials are imported from the U.S., they are taking measures to ensure supply safety and view the tariff impact as a one-time issue [4]. Industry Trends - The Chinese vaccine industry is rapidly developing, with companies like CanSino Biologics transitioning from followers to leaders in vaccine technology, focusing on domestic innovation [6][7]. - The overall sentiment among companies is that the tariff policy presents an opportunity for domestic product substitution, with many firms prepared to adapt to changing market conditions [5][8]. - Companies are increasingly focusing on technological innovation and expanding into emerging markets to counteract potential supply chain disruptions caused by tariffs [5][6][7].

Policy Developments - The National Medical Products Administration (NMPA) released the "Quality Management Specifications for Online Sales of Medical Devices," effective from October 1, 2025, which emphasizes qualification review, information transparency, and risk prevention for online medical device sales [1] Drug and Device Approvals - Insilico Medicine's INS018_055 tablet is expected to receive breakthrough therapy designation for treating idiopathic pulmonary fibrosis [2] - Yuyuan Pharmaceutical's injectable Ganciclovir has passed the consistency evaluation for generic drugs, which will enhance the company's market share and competitiveness [3] - Warner Pharmaceuticals' Bismuth Potassium Citrate Granules have also passed the consistency evaluation for generic drugs, benefiting future market sales [4] - Changchun High-tech's subsidiary, Jinsai Pharmaceutical, received approval for clinical trials of Fuxin Qibai monoclonal antibody injection, aimed at treating endometriosis [5] Financial Reports - Yunnan Baiyao reported a Q1 2025 net profit of 1.935 billion yuan, a 13.67% increase year-on-year, with total revenue of 10.841 billion yuan, up 0.62% [6] - WuXi AppTec's Q1 2025 net profit surged by 89.06% to 3.672 billion yuan, driven by revenue growth and operational efficiency improvements [7][8] - Kefu Medical's 2024 annual report showed a net profit increase of 22.6% to 312 million yuan, with revenue of 2.983 billion yuan, up 4.53% [9] - Hongbo Pharmaceutical's Q1 2025 net profit increased by 226.47% to 11.974 million yuan, with revenue of 16.9 million yuan, up 29.61% [10] Capital Market Activities - Jiangsu Hengrui Medicine has received approval from the China Securities Regulatory Commission for its Hong Kong IPO, planning to issue up to 815.1 million shares [11] - Merck announced its acquisition of SpringWorks for approximately $3.9 billion in equity value [12] - China Merchants Bio intends to increase its stake in Renfu Pharmaceutical by 0.5%-1% within six months, reflecting confidence in the company's future [13] Industry Developments - Xiangyu Medical expects to obtain registration certificates for seven robotic products by 2025, focusing on rehabilitation and other medical applications [14] - Soundon Medical has formed a strategic partnership with MED-EL's BHM to advance global bone conduction hearing solutions [16] - Hanyu Pharmaceutical signed a comprehensive cooperation agreement with Huawei Cloud to focus on "AI Smart Drugs" in drug development [17] Public Sentiment Alerts - Innovative Medical announced that shareholder Shanghai Guanghuan Technology reduced its stake by 3.41 million shares, representing 0.8191% of the total circulating shares [18]

Group 1 - The core viewpoint of the articles highlights the impressive financial performance of Hanyu Pharmaceutical, with a significant revenue increase and successful turnaround in profitability [1][2] - In 2024, the company achieved a revenue of 590 million yuan, a year-on-year growth of 36.82%, and reduced losses by over 60%. In Q1 2025, revenue reached 310 million yuan, with a remarkable year-on-year increase of 106.29% and a net profit of approximately 69.87 million yuan [1] - The growth is attributed to the company's strong foundation in peptide raw materials and formulations, as well as the steady advancement of its GLP-1 drug export strategy [1] Group 2 - Hanyu Pharmaceutical's overseas business has been a significant driver of growth, with overseas revenue increasing by 189.79% to 325 million yuan in 2024 [1] - The company is one of the few globally with large-scale peptide raw materials, offering 32 peptide raw materials and 17 formulation products, reaching over 20 countries for raw materials and over 90 countries for formulations [1] - The partnership with Huawei Cloud aims to explore AI applications in drug development, enhancing efficiency and quality in drug research and production management [2] Group 3 - The company has established a diversified pipeline for short, medium, and long-term development, focusing on several key products such as Teriparatide injection and other promising candidates [3] - Hanyu Pharmaceutical is also advancing its small nucleic acid drugs and CDMO/CMO business, capitalizing on the advantages of oligonucleotide drugs in treating various diseases [3][4] - The integration of resources from its core bases in Wuhan and Shenzhen has created a comprehensive development platform for peptide drugs, enhancing global competitiveness [4] Group 4 - The company plans to continue its strategic focus on talent, innovation, and internationalization, increasing R&D investment and leveraging partnerships to integrate AI into drug development processes [4] - As the strategic layout progresses, Hanyu Pharmaceutical aims to solidify its market position as a leader in the peptide sector, enhancing its global influence and competitiveness [4]

Core Insights - In 2024, Shenzhen Hanyu Pharmaceutical Co., Ltd. demonstrated significant financial improvements, with a notable increase in net cash flow from operating activities and a substantial reduction in sales expenses, indicating a strategic shift in operations and financial management [1][11][4]. Financial Performance Summary - Revenue Growth: The company's revenue for 2024 reached 590.20 million yuan, a 36.82% increase from 431.38 million yuan in 2023, driven by a rise in overseas sales, particularly in peptide formulations and raw materials, with foreign revenue accounting for 55.10% of total revenue [2]. - Profitability: The net profit attributable to shareholders was -173.65 million yuan, a 66.21% reduction from -513.88 million yuan in 2023, reflecting improved revenue and cost control [2]. The adjusted net profit, excluding non-recurring items, was -239.65 million yuan, a 59.44% reduction from -590.91 million yuan [2]. - Earnings Per Share: Basic earnings per share improved to -0.20 yuan from -0.58 yuan in 2023, indicating a narrowing loss [3]. Expense Analysis - Sales Expenses: Sales expenses decreased significantly by 50.76% to 119.49 million yuan from 242.64 million yuan in 2023, suggesting a more efficient sales strategy [4]. - Management Expenses: Management expenses remained relatively stable at 122.45 million yuan, slightly down from 127.70 million yuan in 2023, indicating consistent operational management [5]. - Financial Expenses: Financial expenses decreased by 9.03% to 113.95 million yuan, with interest expenses still high at 106.50 million yuan, reflecting ongoing debt burdens [6]. Research and Development - R&D Expenses: R&D expenses were 88.01 million yuan, down 45.50% from 161.50 million yuan in 2023, primarily due to reduced clinical trial and outsourcing costs [7]. - R&D Investment: Total R&D investment was 119.49 million yuan, accounting for 20.25% of revenue, a significant drop from 44.96% in 2023, with a higher proportion of capitalized R&D expenses [9]. - R&D Personnel: The number of R&D personnel increased slightly to 196, with a stable educational structure, indicating a focus on enhancing team quality [10]. Cash Flow Analysis - Operating Cash Flow: The net cash flow from operating activities surged to 164.71 million yuan from -3.54 million yuan in 2023, marking a 4757.21% increase, reflecting improved cash generation capabilities [11]. - Investment Cash Flow: Investment cash inflow decreased by 77.51% to 51.65 million yuan, while cash outflow increased by 48.52% to 121.66 million yuan, resulting in a net cash flow of -70.01 million yuan [11]. - Financing Cash Flow: Cash inflow from financing activities rose by 10.22% to 1.53 billion yuan, but cash outflow increased by 45.08% to 1.88 billion yuan, leading to a net cash flow of -345.48 million yuan, indicating high reliance on external financing [12].

Core Insights - The company reported a revenue of 590 million yuan for 2024, marking a year-on-year increase of 36.82% [1] - The net cash flow from operating activities reached 165 million yuan, showing a significant growth of 4757.21% [1] - The international business proportion increased from 26.01% to 55.10% through revenue structure optimization [1] Business Performance - The revenue from formulations reached 247 million yuan, up 19.02% year-on-year, while raw material drug revenue was 260 million yuan, reflecting a growth of 114.12% [1] - Sales expenses decreased by 50.76% year-on-year, contributing to profit growth [1] - In Q1 2025, the company continued its growth trend with revenue of 310 million yuan, a year-on-year increase of 106.29%, and a net profit of approximately 69.87 million yuan, marking a turnaround to profitability [1] Future Outlook - The company plans to embrace advancements in biotechnology and artificial intelligence, integrating these technologies into drug development, production, and commercial processes to enhance R&D efficiency and product competitiveness [2] - The company aims to accelerate the globalization strategy for peptide and small nucleic acid formulations, raw materials, and CDMO/CMO businesses, expanding into international markets across North America, South America, Europe, Asia, and the Middle East [2] - The company seeks to establish itself as a brand with international influence through deep collaboration with leading global pharmaceutical companies while focusing on unmet clinical needs to solidify its leading position in the industry [2]

证券代码：300199 证券简称：翰宇药业 公告编号：2025-014 深圳翰宇药业股份有限公司 第六届监事会第二次会议决议公告 本公司及监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。 一、监事会会议召开情况 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）于2025年 4月15日以电子邮件并电话通知方式向公司全体监事发出了召开第六届监事会第 二次会议通知。 本次会议于2025年4月24日下午16:30在公司龙华总部2006董事会会议室以 现场方式召开。会议应到监事3名，实到监事3名，其中监事付梅春先生以通讯表 决方式出席会议。本次会议由监事会主席李庆洋先生主持，公司高级管理人员列 席了本次会议。 本次会议的召集、召开符合《中华人民共和国公司法》和《公司章程》的有 关规定，会议决议合法、有效。 二、监事会会议审议情况 （一）审议通过《关于公司<2024年年度报告>及其摘要的议案》 经审核，监事会认为：董事会编制和审核深圳翰宇药业股份有限公司2024年 年度报告及其摘要的程序符合法律、行政法规和中国证监会的规定，报告内容真 实、准确、完整地反映了公司的实际情况 ...