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上海医药1类创新药信妥安正式获批上市
Xin Hua Cai Jing· 2025-12-12 01:40
其中,拟用于治疗视神经脊髓炎的创新型CD20注射剂B001,拟用于治疗轻、中度脊髓型颈椎病的中药 1类新药参芪麝蓉丸均已完成III期临床试验全部受试者入组;拟用于治疗肌萎缩侧索硬化症(渐冻症) 的中药1类新药SRD4610,拟用于治疗急性缺血性脑卒中的化药1类新药SHPL-49,近期也都已开展III期 临床试验。 此外,上海医药携手高校及顶尖科研机构共同创立的生命科学创新孵化引擎"上海前沿",自去年9月份 正式投入运营以来,已吸引了包括国家级生命研究院,拜耳、礼来等著名的跨国药企,以及上国投、上 海生物医药基金等在内的一大批研发创新机构、专业服务机构和科创企业入驻,形成创新要素加速集聚 的良好生态。 上海医药表示,未来将持续在创新研发领域投入,聚焦肿瘤、免疫、心血管、精神神经、消化代谢、抗 感染等临床需求迫切的领域,推动更多具有临床价值的创新药物上市;同时深化"产学研医资"协同创新 生态,加快创新成果转化。 (文章来源:新华财经) 新华财经上海12月12日电(记者杜康)上海医药集团股份有限公司(以下简称"上海医药")又一款1类 创新药获批。记者获悉,上海上药信谊药厂有限公司申报的1类创新药苹果酸司妥吉仑片已于 ...
上海医药苹果酸司妥吉仑片上市许可申请获批
Bei Jing Shang Bao· 2025-12-10 11:39
北京商报讯(记者 王寅浩 宋雨盈)12月10日,上海医药发布公告称,公司下属上海上药信谊药厂有限 公司收到国家药品监督管理局下发的《药品注册证书》(药品批准文号:国药准字 H20250067),由其 提交的苹果酸司妥吉仑片(SPH3127片)的药品上市许可申请获国家药监局批准。 公告显示,苹果酸司妥吉仑片是新一代口服非肽类小分子肾素抑制剂,通过对肾素的直接抑制,拮抗由 肾素-血管紧张素-醛固酮系统(RAAS)过度激活造成的血压上升,适用于原发性高血压的治疗。 ...
12月10日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-10 10:11
Group 1 - Jicheng Electronics won a total of 15 bids from the State Grid Corporation, with a total bid amount of approximately 215 million yuan, accounting for 8.27% of the company's projected revenue for 2024 [2] - Jianmin Group's chemical generic drug, Ambrutoro Oral Solution, has been approved for market launch by the National Medical Products Administration, aimed at treating cough and wheezing caused by chronic bronchitis and emphysema [3] - Taiji Industry's subsidiary plans to transfer accounts receivable not exceeding 85 million USD to optimize cash flow, with an expected service fee of approximately 285,000 USD [4] Group 2 - Nanjing Pharmaceutical's subsidiary plans to invest 398 million yuan in a modern pharmaceutical logistics expansion project, with a construction period of approximately 35 months [5] - Ruili Kemi received a development notification from a well-known domestic flying car company to supply core components [6] - Ding Tong Technology announced that several executives plan to reduce their holdings by a total of no more than 45,300 shares, representing about 0.032% of the total share capital [7][8] Group 3 - Ninghu Expressway's subsidiary plans to invest no more than 9.033 billion yuan in the construction of the Nanyang Yangtze River Bridge South Connection Project [10] - Wuliangye announced a mid-term profit distribution plan for 2025, proposing a cash dividend of 25.78 yuan per 10 shares, totaling approximately 10 billion yuan [12] - Beixin Road and Bridge's subsidiary won a bid for a project worth 180 million yuan [14] Group 4 - Minhe Livestock reported a 7.75% month-on-month increase in sales revenue from commodity chick sales in November [15] - Xuelong Group plans to invest 100 million yuan to establish a wholly-owned subsidiary for vertical integration in the aluminum and magnesium technology sector [16] - Shengnong Development reported a 15.77% year-on-year increase in sales revenue in November, with significant growth in both poultry and processed meat products [17] Group 5 - Xingyu Co., Ltd. plans to repurchase shares worth 200 million to 300 million yuan for employee stock ownership plans [18] - Quan Chai Power intends to use 50 million yuan of idle funds to purchase structured deposit products [19] - Shibei High-tech appointed Zhao Junhong as the new deputy general manager [20] Group 6 - Fuan Pharmaceutical's subsidiary received a drug registration certificate for injectable isavuconazole, expanding its anti-infection product line [21] - Xiaoming Co. reported a 49.73% year-on-year decline in chicken product sales revenue in November [22] - Baiao Chemical adjusted its share repurchase price ceiling to no more than 48.95 yuan per share [23] Group 7 - Hefei China reported a 26.02% year-on-year decline in consolidated revenue for the first 11 months [24] - Laimei Pharmaceutical's subsidiary received medical device registration certificates for two endoscope products [25][26] - Xiantan Co. reported an 11.63% year-on-year increase in chicken product sales revenue in November [27] Group 8 - Qilin Security received government subsidies totaling 5.4014 million yuan [28] - Blue Sky Gas's controlling shareholder's 30.9134 million shares were judicially frozen, accounting for 4.33% of the total share capital [29] - Tieke Railway signed a contract for high-speed railway fasteners worth 654 million yuan, accounting for 41.08% of the company's projected revenue for 2024 [30] Group 9 - David Medical's electric surgical table received a medical device registration certificate [31] - Zhendong Pharmaceutical's affiliate's core product new drug application was accepted by the CDE [32] - Shanghai Pharmaceutical's apple acid sitagliptin tablet application for market approval was granted by the National Medical Products Administration [33] Group 10 - Nanjiao Food reported a 1.14% year-on-year increase in consolidated revenue for November [34]
上海医药(601607.SH):苹果酸司妥吉仑片(SPH3127片)上市许可申请获得批准
智通财经网· 2025-12-10 08:11
苹果酸司妥吉仑片是新一代口服非肽类小分子肾素抑制剂,通过对肾素的直接抑制,拮抗由肾素-血管 紧张素-醛固酮系统(RAAS)过度激活造成的血压上升,适用于原发性高血压的治疗。体外和体内药效学 研究均表明,苹果酸司妥吉仑片比同靶点药物具有更强的肾素活性抑制作用,并且在高血压、慢性肾病 和炎症性肠病模型中证实了其药效学特征。已完成的临床研究表明,苹果酸司妥吉仑片总体安全性良 好,在高血压患者人群中显示出了明确的降压疗效,能够进一步满足原发性高血压患者的临床需求,为 原发性高血压患者提供一种新的治疗选择。截止目前,苹果酸司妥吉仑片相关项目累计已投入研发费用 约2.96亿元。 智通财经APP讯,上海医药(601607.SH)发布公告,近日,公司下属上海上药信谊药厂有限公司(以下简 称"上药信谊")收到国家药品监督管理局(以下简称"国家药监局")下发的《药品注册证书》(药品批准文 号:国药准字H20250067),由其提交的苹果酸司妥吉仑片(即SPH3127片,以下简称"该药品")的药品上 市许可申请获国家药监局批准。 ...
上海医药:苹果酸司妥吉仑片(SPH3127片)上市许可申请获得批准
Zhi Tong Cai Jing· 2025-12-10 08:09
苹果酸司妥吉仑片是新一代口服非肽类小分子肾素抑制剂,通过对肾素的直接抑制,拮抗由肾素-血管 紧张素-醛固酮系统(RAAS)过度激活造成的血压上升,适用于原发性高血压的治疗。体外和体内药效学 研究均表明,苹果酸司妥吉仑片比同靶点药物具有更强的肾素活性抑制作用,并且在高血压、慢性肾病 和炎症性肠病模型中证实了其药效学特征。已完成的临床研究表明,苹果酸司妥吉仑片总体安全性良 好,在高血压患者人群中显示出了明确的降压疗效,能够进一步满足原发性高血压患者的临床需求,为 原发性高血压患者提供一种新的治疗选择。截止目前,苹果酸司妥吉仑片相关项目累计已投入研发费用 约2.96亿元。 上海医药(601607)(601607.SH)发布公告,近日,公司下属上海上药信谊药厂有限公司(以下简称"上药 信谊")收到国家药品监督管理局(以下简称"国家药监局")下发的《药品注册证书》(药品批准文号:国药 准字H20250067),由其提交的苹果酸司妥吉仑片(即SPH3127片,以下简称"该药品")的药品上市许可申 请获国家药监局批准。 ...
上海医药(601607.SH):苹果酸司妥吉仑片(SPH3127片)上市许可申请获得批准
Ge Long Hui A P P· 2025-12-10 08:04
苹果酸司妥吉仑片是新一代口服非肽类小分子肾素抑制剂,通过对肾素的直接抑制,拮抗由肾素-血管 紧张素-醛固酮系统(RAAS)过度激活造成的血压上升,适用于原发性高血压的治疗。体外和体内药效 学研究均表明,苹果酸司妥吉仑片比同靶点药物具有更强的肾素活性抑制作用,并且在高血压、慢性肾 病和炎症性肠病模型中证实了其药效学特征。已完成的临床研究表明,苹果酸司妥吉仑片总体安全性良 好,在高血压患者人群中显示出了明确的降压疗效,能够进一步满足原发性高血压患者的临床需求,为 原发性高血压患者提供一种新的治疗选择。 格隆汇12月10日丨上海医药(601607.SH)公布,近日,公司下属上药信谊收到国家药监局下发的《药品 注册证书》,由其提交的苹果酸司妥吉仑片(即SPH3127片)的药品上市许可申请获国家药监局批准。 药品名称:苹果酸司妥吉仑片,申报受理号:CXHS2400037。 截止目前,苹果酸司妥吉仑片相关项目累计已投入研发费用约2.96 亿元。 ...
上海医药:苹果酸司妥吉仑片上市许可申请获批
人民财讯12月10日电,上海医药(601607)12月10日公告,公司下属公司上药信谊收到国家药监局下发 的药品注册证书,由其提交的苹果酸司妥吉仑片的药品上市许可申请获国家药监局批准。苹果酸司妥吉 仑片是新一代口服非肽类小分子肾素抑制剂,通过对肾素的直接抑制,拮抗由肾素-血管紧张素-醛固酮 系统(RAAS)过度激活造成的血压上升,适用于原发性高血压的治疗。 ...