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步长制药:全资子公司6033.80万元委托开展药品注册临床试验
Xin Lang Cai Jing· 2025-11-27 10:41
Core Viewpoint - The announcement indicates that the company’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical, has signed a clinical trial outsourcing contract with Beijing Zhuoyue Future for the registration of a new drug, which is expected to enhance the company's research and development capabilities and reduce costs [1] Group 1 - The contract involves a total of 480 cases (including a 20% dropout rate) with a total price of 60.338 million yuan (including tax) [1] - If the final sample size exceeds 520 cases, the additional cases will be charged at a rate of 108,890 yuan per case (including tax) [1] - Shandong Danhong's revenue for 2024 is projected to be 1.331 billion yuan, with a net profit of 226 million yuan; for the first nine months of 2025, revenue is reported at 1.402 billion yuan and net profit at 334 million yuan [1]
山东步长制药股份有限公司关于控股子公司完成医疗器械经营许可证变更登记的公告
Group 1 - Company subsidiary Shanghai Hupu Medical Technology Co., Ltd. has recently obtained a new Medical Device Business License from the Shanghai Fengxian District Market Supervision Administration, involving changes in business scope, location, and warehouse address [1] - The change in the Medical Device Business License is based on actual operational needs and will not have a significant impact on the company's subsequent production and operations [1] Group 2 - On December 3, 2024, the company signed a Clinical Trial Entrustment Contract with Beijing Zhuoyue Future International Pharmaceutical Technology Development Co., Ltd. for the registration clinical trial of the product "Shenfu Yixin Granules" [4] - A supplementary agreement was signed, transferring all rights and obligations of the original contract to the company's wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., which will now handle the subsequent clinical research and registration procedures [5][6] - The signing of the supplementary agreement is expected to facilitate the smooth progress of the project, expand the company's business, enrich the product line, and strengthen market competitiveness without adversely affecting the company's financial status and operating results [7] Group 3 - The company announced adjustments to the members of its fifth board of directors' specialized committees due to the resignation of two directors, including one independent director, and the cancellation of the supervisory board [10] - The adjustments were made to improve the corporate governance structure and ensure the normal operation of the specialized committees [10] - The new members of the specialized committees will serve until the end of the current board's term and will continue to perform their respective duties until the next board's specialized committees are elected [11]
步长制药:关于调整第五届董事会专门委员会组成人员的公告
Zheng Quan Ri Bao· 2025-11-25 13:09
证券日报网讯 11月25日晚间,步长制药发布公告称,鉴于公司两名董事(含一名独立董事)辞去董事 及专门委员会职务,且公司已取消监事会、相应调整董事会人数,为完善公司治理结构,保障公司董事 会专门委员会正常运行,根据公司《董事会议事规则》、各专门委员会工作细则及《山东步长制药股份 有限公司章程》要求,结合公司实际情况,对第五届董事会提名委员会、审计委员会、薪酬与考核委员 会、战略与投资委员会组成人员进行了调整。 (文章来源:证券日报) ...
步长制药(603858) - 山东步长制药股份有限公司关于控股子公司完成医疗器械经营许可证变更登记的公告
2025-11-25 11:01
山东步长制药股份有限公司 关于控股子公司完成医疗器械经营许可证变更登记的公告 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。 山东步长制药股份有限公司控股子公司上海合璞医疗科技有限公司于近日 取得上海市奉贤区市场监督管理局换发的《医疗器械经营许可证》,本次主要涉 及经营范围、经营场所及库房地址的变更,变更后具体内容如下: | 登记信息 | 变更前 | 变更后 | | --- | --- | --- | | 企业名称 | 上海合璞医疗科技有限公司 | 上海合璞医疗科技有限公司 | | 经营方式 | 批发 | 批发 | | 许可证编号 | 沪奉药监械经营许 20220746 号 | 沪奉药监械经营许 20220746 号 | | 法定代表人 | 胡昂 | 胡昂 | | 企业负责人 | 胡昂 | 胡昂 | | 住所 | 上海市奉贤区海湾旅游区莘奉公路 4936、4938、4940 号 3 层 C05、C06 | 上海市奉贤区海湾旅游区莘奉公路 4936、4938、4940 号 3 层 C05、C06 | | | 室 | 室 | | ...
步长制药(603858) - 山东步长制药股份有限公司关于调整第五届董事会专门委员会组成人员的公告
2025-11-25 11:01
证券代码:603858 证券简称:步长制药 公告编号:2025-219 山东步长制药股份有限公司 关于调整第五届董事会专门委员会组成人员的公告 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。 山东步长制药股份有限公司(以下简称"公司")于 2025 年 11 月 18 日发出第 五届董事会第三十七次会议的通知,并于 2025 年 11 月 25 日 13 时以通讯方式召开, 会议以同意 12 票、反对 0 票、弃权 0 票的表决结果审议通过了《关于调整第五届董 事会专门委员会组成人员的议案》,现将相关情况公告如下: 鉴于公司两名董事(含一名独立董事)辞去董事及专门委员会职务,且公司已 取消监事会、相应调整董事会人数,为完善公司治理结构,保障公司董事会专门委 员会正常运行,根据公司《董事会议事规则》、各专门委员会工作细则及《山东步 长制药股份有限公司章程》要求,结合公司实际情况,对第五届董事会提名委员会、 审计委员会、薪酬与考核委员会、战略与投资委员会组成人员进行了调整,具体情 况如下: | 董事会专门委员会名称 | | 主任委 ...
步长制药(603858.SH):控股子公司完成医疗器械经营许可证变更登记
Ge Long Hui A P P· 2025-11-25 11:00
本次医疗器械经营许可证变更主要是基于经营情况的实际需求,对后续生产经营无明显影响。 格隆汇11月25日丨步长制药(603858.SH)公布,山东步长制药股份有限公司控股子公司上海合璞医疗科 技有限公司于近日取得上海市奉贤区市场监督管理局换发的《医疗器械经营许可证》,本次主要涉及经 营范围、经营场所及库房地址的变更。 ...
步长制药(603858) - 山东步长制药股份有限公司关于公司签订药品注册临床试验委托合同的进展公告
2025-11-25 10:45
证券代码:603858 证券简称:步长制药 公告编号:2025-220 山东步长制药股份有限公司 关于公司签订药品注册临床试验委托合同的进展公告 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。 一、交易概述 2024 年 12 月 3 日,山东步长制药股份有限公司(以下简称"公司")与北京 卓越未来国际医药科技发展有限公司(以下简称"北京卓越")签订《参附益心颗 粒注册临床试验委托合同》,委托北京卓越完成参附益心颗粒注册临床试验,具体 内容详见公司 2024 年 12 月 4 日披露于上海证券交易所网站(www.sse.com.cn) 的《关于公司签订药品注册临床试验委托合同的公告》(公告编号:2024-155)。 近日,公司与北京卓越、公司全资子公司山东丹红制药有限公司(以下简称 "山东丹红")签订了《参附益心颗粒注册临床试验委托合同补充协议》。现将具 体内容公告如下: 二、补充协议主要内容 丙方:山东丹红制药有限公司 (一)自本补充协议生效之日起,原合同项下已产生的研究成果及相关资料 所有权归山东丹红制药有限公司(丙方)所 ...
山东步长制药股份有限公司关于公司拟购买安宫牛黄丸药品生产技术相关事宜的进展公告
Transaction Overview - Shandong Buchang Pharmaceutical Co., Ltd. plans to acquire the production technology of An Gong Niu Huang Wan from Liaoning Hancao Tang Chinese Medicine Co., Ltd. for 8.4 million RMB to enrich its product line [2][4] - The formal contract for the transfer of production technology was signed on April 21, 2023, and the contract name was later revised to meet regulatory requirements [3][4] Progress of the Transaction - The company received approval from the National Medical Products Administration to change the marketing authorization holder for An Gong Niu Huang Wan from Liaoning Hancao Tang to Buchang Pharmaceutical in March 2025 [4] - The production site for An Gong Niu Huang Wan has been officially changed to the company's facility in Heze, Shandong Province, with the original formula and standards remaining unchanged [5][6] Sales Performance - Annual sales of An Gong Niu Huang Wan in sample hospitals from 2022 to 2024 were 230.76 million RMB, 241.39 million RMB, and 268.94 million RMB respectively [6] - Sales in urban pharmacies during the same period were 4.57 billion RMB, 5.38 billion RMB, and 4.42 billion RMB respectively [6] R&D Investment - The company has invested approximately 11.97 million RMB in research and development for the An Gong Niu Huang Wan product as of the date of the announcement [7] Impact on the Company - The change in production site is expected to enhance the company's business expansion and product line, thereby strengthening its market competitiveness without significantly impacting current operations [7]
步长制药:公司始终密切关注前沿科技发展趋势
证券日报网讯 步长制药11月21日在互动平台回答投资者提问时表示,公司始终密切关注前沿科技发展 趋势,相关投资决策需综合考量产业政策、技术成熟度及与公司战略的协同性。未来将继续秉持审慎原 则,围绕主业探索优质投资机会。 (编辑 楚丽君) ...
步长制药:推动中药出海及生物药国际化
Zheng Quan Ri Bao Wang· 2025-11-21 15:13
Core Viewpoint - The company is addressing macro challenges such as declining birth rates and reduced consumer willingness by expanding into chemical drugs, biological drugs, and vaccines based on traditional Chinese medicine [1] Group 1: Strategic Focus - The company will focus on major diseases related to aging, such as cardiovascular and oncology, while enhancing the competitiveness of its unique products and evidence-based medical research [1] - The company aims to accelerate its global expansion, promoting the internationalization of traditional Chinese medicine and biological drugs [1] Group 2: Collaborative Development - The company is actively participating in centralized procurement and building a multi-field collaborative research and development pipeline, as well as a diversified product structure [1] - The strategy aims to reduce reliance on single policies and achieve sustainable growth [1]