关于对通化东宝药业股份有限公司 德皓函字202500000105 号 北 京 德 皓 国 际 会 计 师 事 务 所 (特 殊 普 通 合 伙 ) Beijing Dehao International Certified Public Accountants (Limited Liability Partnership) 关于对通化东宝药业股份有限公司 德皓函字2025 00000105号 上海证券交易所上市公司管理一部： 由通化东宝药业股份有限公司（以下简称"通化东宝"或"公 司"）转来的《关于通化东宝药业股份有限公司 2024 年年度报告的 信息披露监管问询函》 （上证公函【2025】0898 号） （以下简称" 《问 询函》"）奉悉，本所作为通化东宝 2024 年度财务报表审计的会计 师事务所，现就《问询函》中需要年审会计师发表意见的有关事项 核查说明如下： 进行两次更正：公司原预计归母净利润 4,053 万元，2 月 26 日进行 第一次更正，将预计归母净利润调整为 1,164 万元，主要系侵害商 标权 诉讼终审判决公司赔付 6,131 万，较此前预计的 3,000 万元差 异较大； 将预计归母净利 ...

智通财经记者 | 李科文 智通财经编辑 | 谢欣 与最初"量增、价跳水"的集采模式不同，在最新一轮胰岛素接续采购中，甘李药业不仅守住了一个相对 合理的中标价格，还凭借成本控制的优势，保住了更多利润。 甘李药业向智通财经记者表示，二次集采规则明确了中选价格线，允许部分产品价格上浮，各采购组内 中选价格的区间均有缩窄，有利于提升市场的有序公平竞争，避免了价格战对企业利润的过度挤压，从 而保障了企业的可持续发展。借助二次集采的政策支持，公司紧抓机遇，在保持A类中选的同时，产品 价格实现合理回调。 吃到集采红利的药企出现了。 7月10日，甘李药业发布2025年上半年度业绩预告。业绩预告显示，2025年上半年，甘李药业实现净利 润6亿元到6.4亿元，与上年同期相比，将增加3.01亿元到3.41亿元，同比增加100.73%到114.12% 此外，2025年上半年，甘李药业实现扣非净利润4.6亿元到5亿元，与上年同期相比，将增加3.33亿元到 3.73亿元，同比增加262.47%到293.99%。 通财经记者李科文制图 智 对于业绩增长原因，7月10日，甘李药业向智通财经记者回应称，本期收入增长可归因于国内、国外销 售收入 ...

2025 年 06 月 25 日 行业日报 看好/维持 医药 <<太平洋医药日报（20250624）：大塚 制药以6.7 亿美元囊获和铂医药双抗 新药 HBM7020>>--2025-06-25 <<太平洋医药日报（20250623）：参天 制药 Ryjunea 在欧盟获批上市>>-- 2025-06-24 <<太平洋医药日报（20250620）： Incyte 单抗 Monjuvi 获 FDA 批准>>- -2025-06-22 证券分析师：周豫 电话： E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 证券分析师：张崴 电话： E-MAIL：zhangwei@tpyzq.com 分析师登记编号：S1190524060001 医药 太平洋医药日报（20250625）：阿斯利康减重新药联合疗法在华 获批临床 ◼ 走势比较 (10%) (2%) 6% 14% 22% 30% 24/6/25 24/9/6 24/11/18 25/1/30 25/4/13 25/6/25 ◼ 子行业评级 | 化学制药 | 无评级 | | --- | --- | | 中药生产 | 无评级 ...

5月27日，通化东宝参与2025年吉林辖区上市公司投资者网上集体接待日。期间管理层就海外市场布局介绍，近年 来，公司积极把握国际市场发展机遇，产品出海战略全面提速。发达国家市场，公司与健友股份已就门冬、甘精、赖 脯3款胰岛素达成战略合作，共同进军美国胰岛素市场，目前相关临床试验正在稳步推进中。 美国市场是公司需重点突破的海外市场，目前公司正在积极推进门冬、甘精、赖脯3款胰岛素在美国的注册申报进 程，预期上半年将提交门冬胰岛素BLA，下半年开始陆续提交甘精胰岛素和赖脯胰岛素BLA。目前公司正持续推进生 产车间美国FDA符合性项目的各项工作。 发展中国家市场，公司已经实现了胰岛素产品在巴西、俄罗斯、波兰等发展中国家的销售。同时，近期内精蛋白人胰 岛素注射液在尼加拉瓜获批上市；精蛋白人胰岛素混合注射液（30R）在乌兹别克斯坦获批上市。 此外，公司持续进一步扩大甘精胰岛素和门冬胰岛素在发展中国家的注册及申请。GLP-1产品方面，公司与科兴制药 合作开拓利拉鲁肽注射液在海外17个新兴市场的销售，目前公司利拉鲁肽注射液已获哥伦比亚GMP证书，接受埃及卫 生部GMP现场审计。 交流中管理层披露，2025年一季度，公司实现约 ...

乳腺癌治疗领域迎来一大重磅消息。 近日，四环医药旗下轩竹生物自主研发的吡洛西利片（商品名：轩悦宁）获批乳腺癌单药及联合氟维司 群双适应症，成为国内唯一拥有单药适应症的CDK4/6抑制剂。 这不仅直接填补了国产创新药在这一领域的临床空白，更标志着我国乳腺癌靶向治疗进入"中国方案"新 阶段。 1、精准匹配中国患者特征，亮眼临床数据破局乳腺癌精准治疗 乳腺癌作为威胁全球女性健康的"头号杀手"，吡洛西利通过独特的"CDK2/4/6/9四靶点作用"机制，在精 准阻断肿瘤细胞增殖通路的同时，能够显著降低血液学毒性发生率，实现对肿瘤的强效持续抑制并提升 治疗耐受性。 这一突破性设计的战略意义，在中国乳腺癌患者中体现的更为深刻。原因在于，我国乳腺癌患者具有中 位发病年龄较西方国家更早、Luminal B型肿瘤、原发耐药及化疗人群比例更高、预后相对较差等特 征，传统治疗方案往往"力不从心"。 从多靶点机制创新到精准匹配中国临床需求的试验设计，吡洛西利的成功上市及其全球领先的疗效数 据，充分彰显了轩竹生物以临床价值为导向的创新研发体系，以及解决重大未满足医疗需求的硬核科技 实力。 2、"医美+创新药"双轮驱动，四环医药基本面全线 ...

5月13日，第36届医药经济信息发布会在广州召开。国家药监局副局长徐景和表示，要全面贯彻落实党 的二十届三中全会精神，落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量 发展的意见》，全过程深化药品监管改革、全方位筑牢药品安全底线、全链条支持产业高质量发展，为 保护和促进公众健康作出更大贡献。 药械审批 泽璟制药：盐酸吉卡昔替尼片治疗重度斑秃的新药上市申请获得受理 政策动向 国家药监局：全过程深化药品监管改革全方位筑牢药品安全底线 荣昌生物RC278获得临床试验申请受理通知书 5月12日，荣昌生物公告，注射用RC278的临床试验申请获CDE受理。RC278是公司自主研发的具有 First-in-Class/Best-in-Class潜质的ADC分子，能特异识别一个新型肿瘤靶点，在临床前研究中展现出广 5月13日，泽璟制药公告称，公司收到国家药品监督管理局核准签发的《受理通知书》，公司递交的盐 酸吉卡昔替尼片治疗重度斑秃的新药上市申请（NDA）获得受理。这是盐酸吉卡昔替尼片第二个申请 新药上市的适应症。盐酸吉卡昔替尼是一种新型的JAK抑制剂，对JAK激酶的四个亚型JAK1、JAK2、 JAK3 ...

点评：浩欧博对2024年年报问询函的回复，体现了公司对监管要求的重视和透明度。通过详细分析经销 商数量变动、选取及管理政策，公司展示了其业务模式的合理性与稳定性。这种积极沟通有助于缓解投 资者对经销模式和终端客户分布的疑虑，增强市场信心。若能持续优化经销商管理，将为公司长期发展 提供有力支撑。 NO.3康基医疗决定终止出售一家附属公司的交易 5月13日，康基医疗发布公告称，公司决定终止出售一家附属公司的交易，并与买方及目标公司订立和 解协议。根据和解协议，买方需退还目标公司账簿及记录，并协助完成股权转回登记；公司则退还买方 500万元，保留剩余4600万元。 丨2025年5月14日星期三丨 NO.1通化东宝精蛋白人胰岛素在尼加拉瓜获批 5月13日，通化东宝（600867）发布公告称，于近日收到尼加拉瓜国家卫生监管局(ANRS)核准签发的精 蛋白人胰岛素注射液的药品注册证书。数据显示，2024年尼加拉瓜20~79岁的糖尿病患者规模上升至 37.7万人，20~79岁的成年人糖尿病患病率为8.7%，未被确诊的糖尿病患者人数占糖尿病总患病人数的 比例达44.6%，患者人均糖尿病相关年度支出金额为587美元。 点评：本 ...

健友股份 20250513 摘要 • 健友股份通过肝素原料药起家，逐步发展到依诺肝素钠注射剂、小分子注 射液，再到大分子生物类似物，构筑了三段成长曲线，并在产业链、生产 技术环节、注册申报、商品化及商业化方面具备显著协同性，实现终端利 润增值。 • 公司深耕美国市场多年，制剂收入占比超 70%，海外制剂占比约 54%。 美国关税调整后，公司估值与股价处于底部，大分子生物类似物进入放量 元年，将成为未来业绩主要驱动引擎。 • 全球生物制药市场规模庞大，生物类似药市场潜力巨大。美国通胀削减法 案（IRA）通过重构医保支付结构，提升医生开具生物类似药处方利润， 迫使保险公司选择成本更低的生物类似药，为生物类似药发展提供契机。 • 健友股份在生物类似药领域积极布局，阿达木单抗预计 2025 年销售收入 可达 3,000 万美元，已获得 75 万只利拉鲁肽订单，预计 2025 年销售 100 万只，并计划于 10 个月内完成高浓度阿达木单抗品种审批。 • 美国无菌注射剂市场长期处于短缺状态，健友股份具备强大的商业化能力 和产能优势，拥有 12 条通过美国 FDA 审核的注射剂生产线，预计 2026 年底至 2027 年 ...

Group 1 - Shengyi Electronics plans to repurchase shares with a total amount between 50 million and 100 million yuan, at a price not exceeding 43.02 yuan per share, for employee stock ownership plans [1] - Guoyao Modern's subsidiary has passed the consistency evaluation for the quality and efficacy of a generic drug, which is used for treating severe infections [1] - Tianhe Magnetic Materials' subsidiaries have obtained project filing notices for high-performance rare earth permanent magnet projects, with total investments of 100 million yuan and 50 million yuan respectively [1][2] Group 2 - Dream Lily intends to repurchase shares with an amount between 85 million and 170 million yuan, at a price not exceeding 10.90 yuan per share, supported by a loan commitment of up to 150 million yuan [3] - Weifu High-Tech has received a loan commitment of up to 135 million yuan from a financial institution for share repurchase [3] Group 3 - Lu'an Environmental Energy reported a coal sales volume of 4.51 million tons in April, a year-on-year increase of 17.75% [5] - *ST Tianshan reported a significant decline in livestock sales and revenue, with a revenue of 70,500 yuan in April, down 95.68% year-on-year [7] Group 4 - Feirongda announced a cash dividend of 0.38 yuan per 10 shares, with a total distribution of 21.9 million yuan [8] - Zhejiang Rongtai's shareholders and executives plan to reduce their holdings by up to 1.93% of the company's shares [9] Group 5 - Changhua Group's subsidiary won the land use rights for an industrial site in Ningbo for 27.05 million yuan, intended for manufacturing and related business [11] - Zejing Pharmaceutical's new drug application for a treatment for severe alopecia has been accepted by the regulatory authority [13][14] Group 6 - Hainan Mining plans to distribute a cash dividend of 0.8 yuan per 10 shares, totaling 1.59 billion yuan [15] - China Jushi plans to distribute a cash dividend of 0.24 yuan per share, totaling 9.61 billion yuan [16] Group 7 - Zhengzhong Design's subsidiary has obtained a utility model patent for an acrylic signage guide [18] - Rundu Co., Ltd. received approval for a veterinary drug product, which is intended for treating bacterial diseases in livestock [20] Group 8 - Emei Mountain A announced the resignation of its general manager due to work reasons [22] - Tonghua Dongbao's insulin injection has received a registration certificate in Nicaragua, allowing for sales in that market [23] Group 9 - Dizu Fashion's subsidiary has completed the registration of a private equity investment fund [24] - Ningbo Gaofa plans to increase capital by 60 million yuan in its subsidiary for operational needs [26] Group 10 - Haichuan Intelligent has obtained two utility model patents for material handling devices [27] - Newland's subsidiary signed a deep cooperation agreement with Alibaba Cloud for AI model applications [29] Group 11 - Rui Neng Technology's controlling shareholder plans to reduce its stake by up to 2.89% [30] - Guomai Culture intends to repurchase shares between 50 million and 100 million yuan for capital reduction [31] Group 12 - Shaanxi Construction won major construction projects totaling 7.88 billion yuan in April [32] - Hanyu Pharmaceutical signed a joint development agreement for a new peptide drug with a partner [34] Group 13 - Yunnan Copper is planning to acquire a 40% stake in Liangshan Mining, leading to a stock suspension [35] - Haizheng Pharmaceutical plans to repurchase shares between 50 million and 100 million yuan for employee stock ownership [36] Group 14 - Tianqiao Hoisting's controlling shareholder plans to increase its stake by 75 million to 150 million yuan [37] - Tiandi Online's controlling shareholder is transferring shares to introduce a strategic investor [38] Group 15 - Hongchang Technology plans to invest 15 million yuan in a joint venture with a partner [39] - Rabbit Baby's subsidiary is preparing for an IPO in Hong Kong [41] Group 16 - Wol Nuclear Materials is planning to issue H-shares for listing in Hong Kong [42] - Tangyuan Electric plans to raise up to 864 million yuan through a private placement for various projects [43] Group 17 - Tongrun Equipment's major shareholders plan to reduce their holdings by up to 2% [44] - Linzhou Heavy Machinery plans to raise up to 600 million yuan through a private placement [46] Group 18 - China Merchants Securities announced the resignation of its vice president [47] - Shangsheng Electronics plans to issue convertible bonds to raise up to 330 million yuan for various projects [48] Group 19 - Longda Co., Ltd.'s major shareholder plans to reduce its stake by up to 1% [49] - China Medical plans to acquire 100% of Jinsui Technology for 302 million yuan [50] Group 20 - Silek has signed a strategic cooperation agreement with a battery manufacturer [51] - Boyun New Materials' major shareholder plans to reduce its stake by up to 3% [53]

Core Insights - The announcement by East China Pharmaceutical (华东医药) regarding its subsidiary Zhejiang Daer Biotechnology's (道尔生物) innovative long-acting triple agonist DR10624 has garnered significant attention due to its promising clinical trial results for treating obesity with hypertriglyceridemia [1][2][9] Group 1: Clinical Trial Results - DR10624 has shown remarkable efficacy in reducing liver fat content (LFC) in a Phase Ib/IIa clinical trial, with reductions of 51.9%, 77.8%, 79.0%, and 75.8% for the 12.5 mg, 25 mg, 50 mg, and 75 mg dosage groups respectively, compared to a placebo group reduction of 26.3% [2][4] - In subjects with baseline LFC ≥8%, the relative reductions were even more pronounced, with reductions of 58.3%, 83%, 89.2%, and 87.2% for the respective dosage groups, again significantly outperforming the placebo group [4][5] - A notable 66.7%, 88.9%, 100%, and 85.7% of subjects in the respective dosage groups achieved a relative reduction of LFC ≥50%, indicating a high likelihood of histological resolution of steatohepatitis [6] Group 2: Drug Development and Pipeline - DR10624 is currently undergoing additional clinical trials in China for treating metabolic-associated fatty liver disease with liver fibrosis and severe hypertriglyceridemia, with results expected in the third quarter of 2025 [6][9] - The company has a robust pipeline of over 80 innovative drug candidates, focusing on endocrine, autoimmune, and oncology fields, with significant advancements in GLP-1 targeted products [7][9] - The oral small molecule GLP-1 receptor agonist HDM1002 has completed its first subject enrollment for weight management in a Phase III trial, with further studies in diabetes also progressing [7][8] Group 3: Market Position and Future Outlook - East China Pharmaceutical is positioning itself as a leader in the endocrine field, with DR10624's breakthrough results and ongoing development of other GLP-1 related products enhancing its competitive edge [9] - The increasing focus on multi-target agonists, particularly those targeting GLP-1, GCGR, and FGF21R, is expected to drive future growth and innovation within the company [6][9] - The company's commitment to R&D is reflected in its significant investment, with a reported R&D expenditure of 2.678 billion yuan, marking a 16.77% year-on-year increase [8]