苹果酸司妥吉仑片
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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
Core Insights - Shanghai Pharmaceuticals announced the approval of its drug, SPH3127 tablets, by the National Medical Products Administration (NMPA) [1] - SPH3127 is a new generation oral non-peptide small molecule renin inhibitor, designed to treat primary hypertension by directly inhibiting renin [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Shanghai Shiyin Pharmaceutical Factory, received the drug registration certificate for SPH3127 [1] - The approval signifies a significant milestone for the company in expanding its product portfolio in the hypertension treatment market [1] Industry Summary - SPH3127 targets the overactivation of the renin-angiotensin-aldosterone system (RAAS), which is a key factor in hypertension [1] - The introduction of new hypertension treatments like SPH3127 reflects ongoing innovation in the pharmaceutical industry aimed at addressing cardiovascular diseases [1]
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
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration for the marketing license of SPH3127 tablets, a new oral non-peptide small molecule renin inhibitor for the treatment of primary hypertension [1] Company Summary - The approved drug, SPH3127, is designed to directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Clinical studies have demonstrated that SPH3127 shows a clear antihypertensive effect in patients with primary hypertension, providing a new treatment option for this patient group [1] - The total research and development investment for SPH3127 has reached approximately 296 million yuan [1] Industry Summary - SPH3127 is positioned as a next-generation treatment in the hypertension market, with stronger renin activity inhibition compared to existing drugs targeting the same pathway [1] - The drug has shown efficacy in models of hypertension, chronic kidney disease, and inflammatory bowel disease, indicating its potential broader therapeutic applications [1]
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
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration for the marketing license of SPH3127 tablets, a new oral non-peptide small molecule renin inhibitor for the treatment of primary hypertension [1] Group 1: Product Approval - The product, SPH3127 tablets (also known as Apixaban), has been granted a drug registration certificate with the approval number H20250067 [1] - The approval signifies a significant milestone for the company in expanding its product portfolio in the hypertension treatment market [1] Group 2: Product Efficacy - SPH3127 tablets directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Preclinical and clinical studies indicate that SPH3127 exhibits stronger renin activity inhibition compared to other drugs targeting the same pathway [1] - Clinical research has demonstrated good overall safety and clear antihypertensive efficacy in patients with primary hypertension, fulfilling a clinical need for new treatment options [1] Group 3: Research and Development Investment - The company has invested approximately 296 million yuan in the research and development of SPH3127 tablets to date [1]
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
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for the marketing license of its new drug, SPH3127 tablets, which is a novel oral non-peptide small molecule renin inhibitor for the treatment of primary hypertension [1] Company Summary - The drug, SPH3127 tablets, is designed to directly inhibit renin, counteracting the blood pressure increase caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - Clinical studies have demonstrated that SPH3127 tablets exhibit a clear antihypertensive effect in patients with hypertension, indicating good overall safety and efficacy [1] - The total research and development investment for SPH3127 tablets has reached approximately 296 million yuan [1] Industry Summary - SPH3127 tablets represent a new treatment option for patients with primary hypertension, addressing an unmet clinical need in this patient population [1] - The drug has shown stronger renin activity inhibition compared to other drugs targeting the same pathway, as evidenced by both in vitro and in vivo pharmacological studies [1]
上海医药:苹果酸司妥吉仑片上市许可申请获批
Zheng Quan Shi Bao Wang· 2025-12-10 07:58
Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Shanghai Pharmaceuticals Xinyi, received a drug registration certificate from the National Medical Products Administration for the approval of its application for the marketing license of Apixaban Tablets, a new generation of oral non-peptide small molecule renin inhibitors [1] Group 1 - The approved drug, Apixaban Tablets, directly inhibits renin, counteracting the increase in blood pressure caused by the overactivation of the renin-angiotensin-aldosterone system (RAAS) [1] - The drug is indicated for the treatment of primary hypertension [1]