CSPC PHARMA(01093)
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石药集团:强效醛固酮合成酶抑制剂( SYH2072片)在美国获临床试验批准
Zhi Tong Cai Jing· 2026-01-13 09:58
该产品是一种高选择性强效醛固酮合成酶抑制剂(ASI),可有效降低血浆醛固酮水平,且不影响皮质醇 水平。本次获批的临床适应症为未控制高血压和难治性高血压。临床前研究显示,该产品可选择性抑制 醛固酮合成酶的活性,在动物疾病模型中显著降低血浆醛固酮水平,并剂量依赖性地降低高血压模型的 血压,同时不影响皮质醇水平。该产品具有良好的药代动力学(PK)特性和安全性,使其具备成为一款同 类最优(best-in-class)药物的潜力。目前,集团已在国内外提交了该产品的多项专利申请。 石药集团(01093)发布公告,集团开发的化药1类新药强效醛固酮合成酶抑制剂(SYH2072片)(该产品)已获 得美国食品药品监督管理局批准,可在美国开展临床试验。该产品亦已于2025年12月获得中华人民共和 国国家药品监督管理局批准在中国开展临床试验。 鉴于醛固酮合成酶抑制剂的临床需求广阔,该产品具有较高的临床开发价值,有望为未控制高血压和难 治性高血压患者提供新的治疗选择。 ...
石药集团(01093) - 自愿公告 - 强效醛固酮合成酶抑制剂(SYH2072片)在美国获临床试验...
2026-01-13 09:51
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準 確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 石 藥 集 團 有 限 公 司 (股份代號:1093) (於香港註冊成立之有限公司) 自願公告 強效醛固酮合成酶抑制劑(SYH2072片) 在美國獲臨床試驗批准 承董事會命 石藥集團有限公司 主席 蔡東晨 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司(「 本 公 司 」, 連 同 其 附 屬 公 司 統 稱「 本 集 團 」)董 事 會(「 董 事 會 」)欣 然 宣 布,本集團開發的化藥1類新藥強效醛固酮合成酶抑制劑( SYH2072片 )(「該產品」)已獲得美 國食品藥品監督管理局批准,可在美國開展臨床試驗。該產品亦已於2025年12月獲得中華 人民共和國國家藥品監督管理局批准在中國開展臨床試驗。 該產品是一種高選擇性強效醛固酮合成酶抑制劑(ASI),可有效降低血漿醛固酮水平,且不 影響皮質醇水平。本次獲批的臨床適應症為未控制高血壓和難治性高血壓 ...
港股异动 | 石药集团(01093)涨超4% 普卢格列汀二甲双胍缓释片上市申请获受理 积极推进三药联合临床开发
智通财经网· 2026-01-13 03:00
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has risen over 4%, currently trading at HKD 9.83 with a transaction volume of HKD 899 million, following the acceptance of its上市申请 for the Ploglitazone Metformin Sustained Release Tablets by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group is actively advancing the clinical development of a combination therapy consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [1] - Ploglitazone is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion in response to glucose and improving hyperglycemia [1] - Metformin is a biguanide that reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases insulin sensitivity by enhancing peripheral glucose uptake and utilization [1]
石药集团涨超4% 普卢格列汀二甲双胍缓释片上市申请获受理 积极推进三药联合临床开发
Zhi Tong Cai Jing· 2026-01-13 02:59
Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) has risen over 4%, currently trading at HKD 9.83 with a transaction volume of HKD 899 million, following the acceptance of its上市申请 for the Ploglitazone Metformin Sustained Release Tablets by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group is actively advancing the clinical development of a combination therapy consisting of Ploglitazone, Dapagliflozin, and Metformin, aiming to benefit more patients [1] - Ploglitazone is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion in response to glucose and improving hyperglycemia [1] - Metformin is a biguanide that reduces hepatic glucose production, inhibits intestinal glucose absorption, and increases insulin sensitivity by enhancing peripheral glucose uptake and utilization [1]
智通港股通资金流向统计(T+2)|1月13日





智通财经网· 2026-01-12 23:32
Core Insights - The article highlights the net inflow and outflow of funds in the Hong Kong stock market, with Xiaomi Group, Tencent Holdings, and China Construction Bank leading in net inflows, while the Yingfu Fund, Hang Seng China Enterprises, and Southern Hang Seng Technology experienced the highest net outflows [1] Group 1: Net Inflows - Xiaomi Group-W (01810) recorded a net inflow of 1.07 billion, representing a 16.36% increase in its closing price [2] - Tencent Holdings (00700) saw a net inflow of 863 million, with a 7.49% increase in its closing price [2] - China Construction Bank (00939) had a net inflow of 699 million, with a significant 41.06% increase in its closing price [2] Group 2: Net Outflows - Yingfu Fund (02800) experienced the largest net outflow of 6.289 billion, reflecting a -31.44% change in its closing price [2] - Hang Seng China Enterprises (02828) had a net outflow of 2.880 billion, with a -17.89% change in its closing price [2] - Southern Hang Seng Technology (03033) faced a net outflow of 1.289 billion, showing a -11.37% change in its closing price [2] Group 3: Net Inflow Ratios - 361 Degrees (01361) led with a net inflow ratio of 74.40%, with a net inflow of 8.9117 million [3] - BRILLIANCE CHI (01114) followed with a net inflow ratio of 64.04%, amounting to a net inflow of 36.4910 million [3] - Qin Port Co. (03369) had a net inflow ratio of 61.05%, with a net inflow of 846,600 [3] Group 4: Net Outflow Ratios - Wisdom Hong Kong 100 (02825) had a net outflow ratio of -100.00%, with a net outflow of -18,200 [3] - Stone Pharmaceutical Group (02005) recorded a net outflow ratio of -68.86%, with a net outflow of -14.1501 million [3] - Dexion Shipping (02510) experienced a net outflow ratio of -53.53%, with a net outflow of -10.0204 million [3]
石药集团:普卢格列汀二甲双胍缓释片的上市申请获国家药监局受理
Zhi Tong Cai Jing· 2026-01-12 12:07
Core Viewpoint - The announcement indicates that the application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets has been accepted by the National Medical Products Administration of China, representing a significant step in the company's innovative drug development [1] Group 1: Product Development - The product is a Class 1 innovative drug combining Ploglitazone and Metformin in an extended-release formulation, aimed at treating adult patients with Type 2 Diabetes Mellitus (T2DM) [1] - The intended indication is for patients with inadequate blood sugar control on Metformin monotherapy or those currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have demonstrated that Ploglitazone shows good efficacy and safety in initial treatment of T2DM patients and those with inadequate control on Metformin monotherapy [2] - The combination of Ploglitazone and Metformin has shown significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia compared to Metformin alone [2] - The product has a low potential for drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] Group 3: Market Strategy - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]
石药集团(01093.HK):普卢格列汀二甲双胍缓释片的上市申请获国家药监局受理
Ge Long Hui· 2026-01-12 12:04
Core Viewpoint - The application for the上市 of Shijiazhuang Pharmaceutical Group's innovative drug, Ploglitazone Metformin Sustained-Release Tablets, has been accepted by the National Medical Products Administration of the People's Republic of China, indicating a significant step in the company's product development pipeline [1] Group 1 - The product is a combination of the innovative drug Ploglitazone and Metformin, classified as a type 2.3 chemical drug registration, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - Ploglitazone is a DPP-4 inhibitor that increases endogenous active GLP-1 levels, enhancing insulin secretion and suppressing glucagon secretion to improve hyperglycemia [1] - Metformin reduces hepatic glucose production and intestinal glucose absorption while increasing peripheral tissue sensitivity to insulin [1] Group 2 - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in T2DM patients, showing significant and sustained blood sugar reduction compared to Metformin monotherapy, with a lower incidence of hypoglycemia [2] - The combination of Ploglitazone and Metformin has a lower likelihood of drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]
石药集团(01093):普卢格列汀二甲双胍缓释片的上市申请获国家药监局受理
智通财经网· 2026-01-12 11:59
Core Viewpoint - The application for the上市 of the combination drug Ploglitazone Metformin extended-release tablets developed by the company has been accepted by the National Medical Products Administration of China [1] Group 1: Product Information - The product is a first-class innovative drug combining Ploglitazone and Metformin in a sustained-release formulation, aimed at treating adult patients with type 2 diabetes mellitus (T2DM) [1] - The proposed indication is for use in T2DM patients who have inadequate blood sugar control with Metformin monotherapy or are currently receiving a combination of Ploglitazone and Metformin [1] Group 2: Clinical Trial Results - Phase III clinical trials have confirmed that Ploglitazone demonstrates good efficacy and safety in initial treatment of T2DM patients and those with inadequate blood sugar control on Metformin monotherapy [2] - Compared to Metformin monotherapy, the combination of Ploglitazone and Metformin shows significant and sustained blood sugar-lowering effects with a lower incidence of hypoglycemia [2] - The product has a low potential for drug interactions and does not require dosage adjustment for patients with mild to moderate renal impairment [2] Group 3: Treatment Simplification - The combination formulation simplifies treatment regimens and significantly improves patient adherence, leading to more effective blood sugar control compared to the use of two separate formulations [2] - The company is actively advancing the clinical development of a three-drug combination formulation consisting of Ploglitazone, Dapagliflozin, and Metformin to benefit more patients [2]
石药集团(01093) - 自愿公告 - 普卢格列汀二甲双胍缓释片的上市申请获国家药监局受理
2026-01-12 11:53
在初始治療的T2DM患者以及二甲雙胍單藥治療血糖控制不佳的T2DM患者中開展的Ⅲ期臨 床試驗證實,普盧格列汀具有良好的有效性和安全性。與二甲雙胍單藥治療相比,普盧格 列 汀 聯 合 二 甲 雙 胍 具 有 顯 著 且 持 久 的 降 糖 作 用 , 低 血 糖 發 生 率 較 低 , 且 安 全 性 良 好 。 此 外,該產品與其他藥物發生相互作用的可能性較低,輕中度腎功能不全患者服用該產品時 無需調整劑量。與兩種單方製劑聯合應用相比,複方製劑可簡化治療方案、顯著提高患者 依從性,從而更有效地控制血糖。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準 確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 (股份代號:1093) (於香港註冊成立之有限公司) 自願公告 普盧格列汀二甲雙胍緩釋片的上市申請 獲國家藥監局受理 石 藥 集 團 有 限 公 司(「 本 公 司 」, 連 同 其 附 屬 公 司 統 ...
港股通医疗ETF华宝(159137)涨0.38%,成交额1.73亿元
Xin Lang Cai Jing· 2026-01-12 07:15
Core Insights - The Huabao CSI Hong Kong Stock Connect Medical Theme ETF (159137) closed with a gain of 0.38% on January 12, with a trading volume of 173 million yuan [1] Fund Overview - The fund was established on December 31, 2025, and is officially named Huabao CSI Hong Kong Stock Connect Medical Theme Exchange-Traded Fund [1] - The management fee is set at 0.50% per annum, while the custody fee is 0.10% per annum [1] - The performance benchmark for the fund is the return of the CSI Hong Kong Stock Connect Medical Theme Index, adjusted for the RMB exchange rate [1] Fund Management - The current fund manager is Zhang Fang, who has managed the fund since its inception, achieving a return of 4.33% during the management period [1] Top Holdings - The latest report indicates that the top holdings of the ETF include: - WuXi Biologics: 2.65% holding, valued at approximately 7.49 million yuan [2] - JD Health: 2.02% holding, valued at approximately 5.71 million yuan [2] - WuXi AppTec: 1.44% holding, valued at approximately 4.07 million yuan [2] - Crystal Digital Holdings: 0.98% holding, valued at approximately 2.76 million yuan [2] - Alibaba Health: 0.93% holding, valued at approximately 2.63 million yuan [2] - WuXi AppTec Holdings: 0.86% holding, valued at approximately 2.43 million yuan [2] - Sinopharm: 0.72% holding, valued at approximately 2.04 million yuan [2] - Genscript Biotech: 0.55% holding, valued at approximately 1.55 million yuan [2] - Ping An Good Doctor: 0.46% holding, valued at approximately 1.31 million yuan [2] - CSPC Pharmaceutical Group: 0.41% holding, valued at approximately 1.17 million yuan [2]