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鲁抗医药(600789) - 鲁抗医药关于CMS203片IIb期临床试验完成首例受试者入组的公告
2026-03-30 10:15
证券代码:600789 证券简称:鲁抗医药 公告编号:2026—010 山东鲁抗医药股份有限公司 关于 CMS203 片 IIb 期临床试验完成首例受试者入组的公告 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。 近日,公司研发的化学药品 1 类创新药 CMS203 片已正式进入 IIb 期临床试 验,即"评价口服不同剂量 CMS203 片治疗男性勃起功能障碍的有效性、安全 性的多中心、随机、双盲、安慰剂平行对照临床试验"首例受试者已入组。现将 相关内容公告如下: 一、药品基本信息 药品名称:CMS203 片 剂型:片剂 注册分类:化学药品 1 类 适应症:男性勃起功能障碍 临床受理号:CXHL2101264、CXHL2101265 临床批件号:2021LP01468、2021LP01478 临床试验分期:IIb 期 二、药品研究情况 2021 年 9 月,公司收到国家药品监督管理局签发的《药物临床试验批准通 知书》。 2023 年 4 月,公司完成Ⅰ期临床试验并取得Ⅰ期临床研究总结报告,研究 结果显示 CMS203 片各研究 ...
鲁抗医药(600789) - 鲁抗医药关于控股子公司获得枸橼酸西地那非片补充申请批准通知书暨成为药品上市许可持有人的公告
2026-03-25 10:01
剂型:片剂 规格:100mg(按 C₂₂H₃₀N₆O₄S 计)、50mg(按 C₂₂H₃₀N₆O₄S 计)、20mg(按 C₂₂H₃₀N₆O₄S 计) 证券代码:600789 证券简称:鲁抗医药 公告编号:2026-009 山东鲁抗医药股份有限公司 关于控股子公司获得枸橼酸西地那非片补充申请批准通知书 暨成为药品上市许可持有人的公告 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。 近日,山东鲁抗医药股份有限公司(以下简称"公司")控股子公司山东鲁 抗医药集团赛特有限责任公司(以下简称"赛特公司")收到国家药品监督管理局 核准签发的枸橼酸西地那非片(以下简称"该药品")《药品补充申请批准通知 书》(通知书编号:2026B01791、2026B01792、2026B01793),同意赛特公司作 为上述药品上市许可持有人。现将相关情况公告如下: 一、药品基本信息 药品通用名称:枸橼酸西地那非片 原药品批准文号:国药准字 H20263153、国药准字 H20263154、国药准字 H20263157 注册分类:化学药品 受理号:CYH ...
鲁抗医药创新发展生物农药,助力农业绿色发展
Qi Lu Wan Bao· 2026-02-25 00:44
Core Viewpoint - The company emphasizes green and low-carbon development in modern agriculture, positioning itself as a leader in the biological pesticide sector, advocating for a green revolution in agriculture [1][2]. Group 1: Company Overview - Shandong Lukang Biological Pesticide Co., Ltd. is a wholly-owned subsidiary of Lukang Pharmaceutical (600789) and is recognized as a national high-tech enterprise and designated pesticide production company [1]. - The company has a comprehensive range of biological pesticides and significant scale advantages, supported by 60 years of technical accumulation in microbial fermentation [1]. Group 2: Product Development and Innovation - The company focuses on discovering natural active ingredients from plant and microbial sources to create biological insecticides, fungicides, and plant growth regulators, contributing to ecological protection in agriculture [1][2]. - Recent investments in research and development have led to breakthroughs in microbial synthesis mechanisms and high-yield engineered strains, enhancing the production of biological pesticides [2]. - Key products include a biocontrol agent for nematodes, which is progressing well in field trials, and several products like multi-fungicides have received U.S. patent authorization, becoming mainstream brands in the market [2]. Group 3: Future Plans and Goals - During the "14th Five-Year Plan" period, the company aims to expand the quantity and scale of fermentation-based pesticides, striving to become a leading biological pesticide enterprise in China [3]. - The company plans to reduce the cost of pesticide formulations and enhance its innovation capabilities, accelerating the registration and production of innovative pesticides to ensure safe agricultural production and ecological balance [3].
鲁抗医药:“米诺地尔搽剂”取得注册证
Mei Ri Jing Ji Xin Wen· 2026-02-24 16:07
Group 1 - The core point of the article is that Shandong Lukang Pharmaceutical Co., Ltd. announced the approval of Minoxidil topical solution as a generic drug by the National Medical Products Administration, indicating it has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2 - The approved product is named "Minoxidil topical solution" and is classified as a Class 3 new registration generic drug [1]
鲁抗医药(600789.SH):控股子公司的米诺地尔搽剂获得药品注册证书
Ge Long Hui· 2026-02-24 10:23
Core Viewpoint - The company, LuKang Pharmaceutical (600789.SH), announced that its subsidiary, Shandong LuKang Pharmaceutical Group Saiter Co., Ltd., received a drug registration certificate from the National Medical Products Administration for Minoxidil topical solution, which is classified as a generic drug and has passed the consistency evaluation of quality and efficacy for generic drugs [1]. Group 1 - The drug Minoxidil is classified as a potassium channel opener and is primarily used for treating hypertension, but it also has the side effect of hypertrichosis [1]. - The U.S. company Upjohn conducted research on the adverse effects of Minoxidil and found that its topical solution is effective in treating hair loss [1]. - Minoxidil was approved by the U.S. FDA in September 1988 for the treatment of alopecia areata in men and chemotherapy-induced hair loss, with subsequent approvals for use in women and a higher concentration formulation for men [1]. Group 2 - Currently, there are various formulations of Minoxidil available in China, including topical solutions and tinctures, used for treating hair loss [1]. - The newly approved product is indicated for the treatment of male pattern baldness and alopecia areata [1].
鲁抗医药(600789.SH):米诺地尔搽剂获得药品注册证书
智通财经网· 2026-02-24 09:57
Core Viewpoint - The company, Lu Kang Pharmaceutical (600789.SH), announced that its subsidiary, Shandong Lukang Pharmaceutical Group Saiter Co., Ltd., has received a drug registration certificate from the National Medical Products Administration for Minoxidil lotion, which is classified as a Category 3 generic drug and has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The drug registration certificate was issued with batch numbers 2026S00478 and 2026S00479 [1] - The approval signifies that the drug is recognized as a generic version that meets the required quality and efficacy standards [1]
鲁抗医药(600789) - 鲁抗医药关于控股子公司获得药品注册证书的公告
2026-02-24 09:45
证券代码:600789 证券简称:鲁抗医药 公告编号:2026-008 山东鲁抗医药股份有限公司 关于控股子公司获得药品注册证书的公告 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。 近日,山东鲁抗医药股份有限公司(以下简称"公司")控股子公司山东鲁 抗医药集团赛特有限责任公司(以下简称"赛特公司")收到国家药品监督管理 局颁发的关于米诺地尔搽剂(以下简称"该药品")的《药品注册证书》(批件 号:2026S00478、2026S00479),该药品是按照新注册分类 3 类获批的仿制药, 视为通过仿制药质量和疗效一致性评价。现将相关情况公告如下: 一、药品证书基本信息 药品名称: 米诺地尔搽剂 剂型: 搽剂 规格:5%(60 毫升:3.0 克)、2%(60 毫升:1.2 克) 原药品批准文号:国药准字 H20263408、国药准字 H20263407 药品注册标准编号:YBH35432025 注册分类:化学药品 3 类 生产企业:山东鲁抗医药集团赛特有限责任公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 ...
山东鲁抗医药股份有限公司 关于收到南厂区土地收储补偿款的进展公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-13 22:56
Overview - The company, Shandong Lukang Pharmaceutical Co., Ltd., has approved the government acquisition of part of its state-owned land use rights, involving a total area of 237,100 square meters (approximately 355.65 acres) [1] - The company will receive a total compensation of 360.396 million yuan for the land acquisition, which includes a specific compensation of 22.82256 million yuan for land previously owned by Shandong Lukang Pharmaceutical Group Co., Ltd. [1] Compensation Progress - The company has received a total of 152.277 million yuan in land compensation payments to date, with an outstanding balance of 208.119 million yuan yet to be received [2] - The compensation payments were received in multiple installments, including 20 million yuan on September 29, 2024, 32.277 million yuan on May 22, 2025, 50 million yuan on August 27, 2025, 20 million yuan on September 25, 2025, and 10 million yuan on December 30, 2025 [2] Future Actions - The company will closely monitor and follow up on the progress of the remaining land compensation payments and related matters, ensuring timely information disclosure to investors [3]
鲁抗医药(600789) - 鲁抗医药关于收到南厂区土地收储补偿款的进展公告
2026-02-13 09:45
证券代码:600789 证券简称:鲁抗医药 公告编号:2026-007 山东鲁抗医药股份有限公司 (公告编号:2022-066)、《鲁抗医药关于公司南厂区土地办理完成移交手续 暨进展公告》(公告编号:2024-034)。 2024年9月29日,公司收到第一笔土地收储补偿款2,000万元;2025年5月22 日,公司收到第二笔土地补偿款3,227.70万元;2025年8月27日,公司收到第三 笔土地补偿款5,000万元;2025年9月25日,公司收到第四笔土地补偿款2,000万 元;2025年12月30日,公司收到第五笔土地补偿款1,000万元。具体内容详见公 司2024年9月30日、2025年5月23日、2025年8月28日、2025年9月26日、2025年 12月31日披露的《关于收到南厂区土地收储补偿款的进展公告》(公告编号: 2024-048、2025-025、2025-042、2025-049、2025-060)。 二、本次收储相关事项的进展情况 2026年2月13日,公司收到第六笔土地补偿款2,000万元。截至目前公司已 收到土地补偿款15,227.70万元,尚未收到补偿款余额20,811.90万元 ...
鲁抗医药:收到南厂区第六笔土地收储补偿款2000万元
Xin Lang Cai Jing· 2026-02-13 09:36
Group 1 - The company announced the acquisition of five state-owned construction land parcels totaling 237,100 square meters, with a total compensation fee of 360.396 million yuan [1] - As of February 13, 2026, the company received the sixth installment of land compensation amounting to 20 million yuan [1] - The total compensation received to date is 152.277 million yuan, with an outstanding balance of 208.119 million yuan yet to be received [1]