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华纳药厂: 国投证券股份有限公司关于湖南华纳大药厂股份有限公司部分募集资金投资项目子项目调整及延期的专项核查意见
Zheng Quan Zhi Xing· 2025-06-13 12:00
国投证券股份有限公司 关于湖南华纳大药厂股份有限公司 部分募集资金投资项目子项目调整 及延期的专项核查意见 国投证券股份有限公司(以下简称"国投证券"或"保荐机构")作为湖南 华纳大药厂股份有限公司(以下简称"华纳药厂"或"公司")向不特定对象发 行可转换公司债券的保荐机构,根据《证券发行上市保荐业务管理办法》《上市 公司监管指引第 2 号—上市公司募集资金管理和使用的监管要求(2022 年修订)》 《上海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》《上海证 券交易所科创板股票上市规则》《湖南华纳大药厂股份有限公司募集资金管理制 度》等有关规定,对公司部分募集资金投资项目子项目调整及延期进行了认真、 审慎的核查,并发表意见如下: 一、募集资金投资项目概况 (一)募集资金基本情况 根据中国证券监督管理委员会《关于同意湖南华纳大药厂股份有限公司首次 公开发行股票注册的批复》 (证监许可〔2021〕1966 号),公司由主承销商西部证 券股份有限公司采用余额包销方式,向社会公众公开发行人民币普通股(A 股) 股票 2,350 万股,发行价为每股人民币 30.82 元,共计募集资金 72,427.00 ...
东北制药破局国际抗生素市场壁垒 国内首家斩获磷霉素氨丁三醇原料药CEP证书
近日,东北制药(000597)宣布其核心原料药产品磷霉素氨丁三醇正式通过欧洲药品质量管理局 (EDQM)注册,获得欧盟原料药欧洲药典适用性证书(CEP证书)。这一里程碑式突破,不仅使东北制药 成为国内首家斩获该产品CEP注册的制药企业,更标志着中国在抗生素原料药全球高端市场供应链中的 地位实现跨越式提升。 国内首家斩获CEP注册叩开欧盟高端市场 作为全球最严苛、最具影响力的药品监管机构之一,欧盟EDQM颁发的CEP证书被誉为进入欧美市场 的"金钥匙"。该注册对产品的生产工艺、质量管控、杂质研究等全流程实施严格审查,其标准远超普通 国际注册要求。 "此次东北制药磷霉素氨丁三醇成功'通关',证明我们的产品质量控制完全符合欧洲药典标准,达到了 国际一流水平。"东北制药原料质量部部长魏艳表示。 值得关注的是,CEP证书具有广泛的国际认可度,不仅被所有欧盟成员承认,也被其他签订了互认协议 的国家认可。这意味着,制剂企业选用东北制药的原料药,在向欧盟申请药品上市许可时,可直接引用 该CEP证书来证明原料药的质量,从而极大简化申报流程、缩短上市周期并降低注册成本。 "长期以来,高端抗生素原料药市场由欧洲、印度等企业主导,此 ...
深耕大健康赛道培育全产业链生态
● 本报记者 宋维东 今年以来,东北制药药品国际认证取得重要进展。6月4日晚,东北制药发布公告,公司原料药磷霉素氨 丁三醇收到欧洲药品质量管理局签发的CEP证书。值得一提的是,东北制药是国内磷霉素氨丁三醇原料 药生产企业中第一家获得CEP证书的企业,本次CEP注册也是该产品首次通过的欧盟高端注册。东北制 药表示,此举对提升该产品在国际市场上的地位将起到重要的推动作用。 "公司通过混改加入辽宁方大集团后,持续加大研发投入,坚持仿制药、创新药'双创新'驱动,扬长避 短,加速新产品研发进度,打造更具市场竞争力的产品梯队。"东北制药党委书记王新鹏说,"特别是去 年收购鼎成肽源后,公司布局了TCR-T和CAR-T细胞治疗领域,针对肝癌、胰腺癌等肿瘤疾病开发了10 余款产品,加快培育生物创新药业务,打造业绩新增长点。" 东北制药总经理蔡永刚表示,东北制药作为一家有着近80年历史的老牌药企,多年的业务积累和市场拓 展让公司"原料+制剂"一体化优势愈加显著。公司将认真总结混改经验,发挥体制机制新优势,借助辽 宁方大集团这一更大的平台,不断加大创新研发力度,进一步做精做优仿制药,积极布局生物药赛道, 在提升研发创新能力、扩大市 ...
创新研发与精益管理联动 东北制药战略转型开启新成长周期
● 本报记者宋维东 东北制药(000597)相关负责人日前在接受中国证券报记者采访时表示,今年以来,公司坚定不移推动 战略转型,通过面向未来的创新研发和刀刃向内的管理改革,不断提升整体经营质量。下一步,公司将 通过战略聚焦与精准投入,特别是要抓住收购鼎成肽源机遇,推动细胞治疗等创新成果商业化落地,不 断积蓄发展动能,进一步增强内生动力与长期发展潜力,加快转型升级步伐,推动公司开启新成长周 期,实现从传统化学药领军企业向生物药龙头企业转型。 研发管线加速突破 东北制药作为国家企业技术中心和国家级科技创新平台,近年来通过"创新药+仿制药"双轮驱动战略, 构建了覆盖神经系统、消化系统、内分泌及代谢、肿瘤、自身免疫性疾病等多领域的产品矩阵,不断增 强发展潜力。同时,在创新药前沿领域加速战略布局,今年以来研发投入显著提升,直指肿瘤免疫治疗 这一医药行业风口领域。 "公司于2024年完成了对鼎成肽源的收购,拿到了进入特异性细胞免疫治疗领域的'直通门票',在获得 从早期研发到即将进入临床Ⅰ期产品管线的同时,还获得了特异性细胞免疫治疗领域的核心技术和成熟 的研发团队。"该负责人说。 以控成本为例,东北制药在严格保证产品质量的 ...
诚意药业:业绩稳增 多领域布局展潜力
He Xun Wang· 2025-04-30 07:04
Core Viewpoint - Chengyi Pharmaceutical reported significant growth in revenue and net profit for 2024 and Q1 2025, highlighting its strategic focus on marine biomedicine and integrated drug production [1] Financial Performance - In 2024, the company's revenue reached 714 million yuan, a year-on-year increase of 6.36%, while the net profit attributable to shareholders was 201 million yuan, reflecting a substantial growth of 23.21% [1] - For Q1 2025, revenue was 186 million yuan, showing a year-on-year growth of 21.26%, and net profit was 45.79 million yuan, up 40.10% compared to the previous year [1] - The company plans to distribute a cash dividend of 2.5 yuan per 10 shares, totaling approximately 79.42 million yuan, alongside a share buyback of 67.26 million yuan, amounting to a total of 147 million yuan, which represents 73.09% of the net profit [1] Product and Market Development - Revenue from joint disease medications in 2024 was 502 million yuan, marking a year-on-year increase of 23.41%, with Q1 2025 revenue at 143 million yuan, a significant rise of 49.62% [1] - Chengyi Pharmaceutical is the first listed company in Zhejiang Province focusing on marine biomedicine, with its core product, glucosamine hydrochloride, sourced from chitin derived from crab and shrimp shells, establishing itself as a major supplier in China [1] - The company has six domestic health food products, with the new "Haicuiwei Fish Oil Soft Capsule" expected to complete registration and launch by December 2024 [1] Strategic Initiatives - Chengyi Pharmaceutical is actively developing a production capacity project for 1,000 tons of super fish oil EPA and is pushing for the application of new drugs such as EPA soft capsules [1] - During the reporting period, several products, including lidocaine injection and amikacin sulfate injection, passed consistency evaluations, while new products like calcitriol soft capsules and levocarnitine injection received approval [1] - The company aims to focus on four major industrial sectors and deepen its integrated strategy of "raw materials + formulations" [1]
诚达药业股份有限公司2024年年度报告摘要
证券代码:301201 证券简称:诚达药业 公告编号:2025-010 一、重要提示 本年度报告摘要来自年度报告全文,为全面了解本公司的经营成果、财务状况及未来发展规划,投资者 应当到证监会指定媒体仔细阅读年度报告全文。 所有董事均已出席了审议本报告的董事会会议。 众华会计师事务所(特殊普通合伙)对本年度公司财务报告的审计意见为:标准的无保留意见。 本报告期会计师事务所变更情况:公司本年度会计师事务所没有变更,为众华会计师事务所(特殊普通 合伙)。 非标准审计意见提示 □适用 √不适用 公司上市时未盈利且目前未实现盈利 □适用 √不适用 董事会审议的报告期利润分配预案或公积金转增股本预案 √适用 □不适用 公司经本次董事会审议通过的利润分配预案为:以公司当前总股本154,713,824股剔除回购专户中的已回 购股份3,244,700股后的股本151,469,124股为基数,向全体股东每10股派发现金红利2元(含税),送红 股0股(含税),以资本公积金向全体股东每10股转增0股。 董事会决议通过的本报告期优先股利润分配预案 ■ 2、报告期主要业务或产品简介 公司主营业务涵盖为跨国制药企业及医药研发机构提供关键医 ...
东北制药净利润实现四连增 布局生物药赛道打造第二成长曲线
Zheng Quan Ri Bao· 2025-04-03 07:08
Core Viewpoint - Northeast Pharmaceutical Group Co., Ltd. has shown continuous improvement in profitability, driven by market expansion and innovation in research and development [2][4]. Financial Performance - In the 2024 annual report, the company reported operating revenue of 7.503 billion yuan, a slight decrease year-on-year; net profit reached 410 million yuan, an increase of 14.34%; and non-net profit was 312 million yuan, up 18.97% [2]. - Both net profit and non-net profit have achieved four consecutive years of growth, reaching the highest levels since 2010 [2]. Dividend Distribution - The company plans to distribute a cash dividend of 1 yuan (including tax) for every 10 shares to all shareholders [3]. Competitive Advantages - Northeast Pharmaceutical is a significant drug production and export base in China, with integrated production bases for raw materials and formulations [4]. - The company has a diverse product line covering ten major series, including vitamins and anti-infection drugs, with products exported to over 100 countries and regions [4]. - The company increased its R&D investment to 149 million yuan, a year-on-year growth of 7.55% [4][5]. Innovation and Product Development - In 2024, the company successfully obtained one innovative drug candidate and approved five generic drugs for production [5]. - The company received approval for raw material drug listings and registered certificates for several new products, enhancing its product portfolio [5]. - The company’s raw materials, such as L-carnitine and vitamin C, received CEP certification from the European Medicines Agency, allowing sales in the EU high-end pharmaceutical market [5]. Export Business - The export business generated revenue of 902 million yuan in 2024, reflecting a year-on-year increase of 26.30%, with a gross margin growth of 5.89% [6]. Strategic Acquisition - The company is expanding into the biopharmaceutical sector by acquiring Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., focusing on cell immunotherapy technology [7][8]. - Dingcheng Peptide Source has developed a complete technical platform for TCR-T and CAR-T cell therapy products targeting various cancers [7]. - This acquisition is expected to enhance the company's competitiveness in the biopharmaceutical field and accelerate the R&D and commercialization of innovative drugs [8].