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石四药集团:盐酸屈他维林已获批登记成为在上市制剂使用的原料药
Zhi Tong Cai Jing· 2025-08-06 10:55
Group 1 - The core point of the article is that the company, Shijiazhuang Fourth Pharmaceutical Group, has received approval from the National Medical Products Administration of China for its raw material drug, Hydrochloride of Butylscopolamine, to be used in marketed formulations [1] Group 2 - Hydrochloride of Butylscopolamine is an antispasmodic drug primarily used for treating spasms in the biliary, urinary, and gastrointestinal tracts [1]
石四药集团(02005.HK):盐酸屈他维林已获批准登记成为在上市制剂使用的原料药
Ge Long Hui· 2025-08-06 10:47
Group 1 - The core point of the article is that Sihuan Pharmaceutical Group has received approval from the National Medical Products Administration of China for its raw material drug, Hydrochloride of Butylscopolamine, to be used in marketed formulations [1] - Hydrochloride of Butylscopolamine is an antispasmodic drug primarily used for treating spasms in the biliary, urinary, and gastrointestinal tracts [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-08-06 10:42
自願公告 產品開發的最新進展 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,概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 本公告為本公司自願發佈,目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 承董事局命 執行董事兼公司秘書 周興揚 香港,二零二五年八月六日 於本公告日期,董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士,非執行董事劉文軍先生,以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 石四藥集團有限公司(「本公司」,連同其附屬公司,「本集團」)董事局(「董事局」)欣然公告, 本集團的鹽酸屈他維林已獲中國國家藥品監督管理局批准登記成為在上市製劑使用的原料藥。 鹽酸屈他維林是一種解痙藥,主要用於治療膽道、泌尿道和胃腸道痙攣。 ...
石四药集团(02005) - 股份发行人的证券变动月报表
2025-08-01 03:14
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 石四藥集團有限公司 呈交日期: 2025年8月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02005 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | HKD | | 0.02 | HKD | | 200,000,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 10,000,000,000 | HKD | | 0.02 | HKD | | 200,000,000 | 本月底法定/註 ...
石四药集团(02005.HK)获瑞舒伐他汀依折麦布片(I)(10mg)生产注册批件
Ge Long Hui A P P· 2025-07-30 06:23
瑞舒伐他汀依折麦布片(I)主要用于饮食控制的基础上,治疗成人原发性(杂合子型家族性或非家族性)高 胆固醇血症或混合性高脂血症,及纯合子型家族性高胆固醇血症(HoFH)。 格隆汇7月28日丨石四药集团(02005.HK)公告,集团已取得中国国家药品监督管理局有关瑞舒伐他汀依 折麦布片(I)(10mg)的药品生产注册批件,属于化学药品第4类,视同通过一致性评价,是国内企业第三 家获批。 ...
石四药集团(02005.HK):本集团的氯化铜已获中国国家药品监督管理局批准登记成为在上市制剂使用的原料药,是国内企业第三家获批。氯化铜是无机盐类,是多种微量元素注射液所用的原料,主要用于补充微量元素的需求。
news flash· 2025-07-14 09:39
石四药集团(02005.HK):本集团的氯化铜已获中国国家药品监督管理局批准登记成为在上市制剂使用的 原料药,是国内企业第三家获批。氯化铜是无机盐类,是多种微量元素注射液所用的原料,主要用于补 充微量元素的需求。 ...
石四药集团:1类新药SYN045片计划开展二a期临床试验,以确定人体内量效关系
Cai Jing Wang· 2025-07-08 03:36
Core Insights - The company has made significant progress in the development of its innovative drug SYN045, which has received approval for Phase I clinical trials in three different dosages from the National Medical Products Administration of China [1] - The results from the completed clinical trials indicate favorable pharmacokinetic characteristics, enhanced safety, and tolerability compared to similar drugs, supporting the potential for long-term oral administration [1] - The company has submitted a total of 18 invention patents related to the SYN045 project, including 5 international patents and 13 domestic patents, with some already granted [1] Group 1: SYN045 Development - SYN045 is a highly selective PGI2 receptor agonist showing significant anti-pulmonary arterial hypertension effects in animal studies [1] - The company plans to conduct Phase IIa clinical trials based on the final results of Phase I to determine the dose-response relationship and explore efficacy and safety in patients [1] Group 2: Other Drug Developments - The company is developing an innovative anti-epileptic drug targeting the potassium ion channel KCNQ2/3, currently in the compound screening phase and preparing for toxicity evaluation [2] - An innovative drug for diabetic peripheral neuropathic pain is also under development, targeting AAK1, with compound screening currently underway [2] - The company is working on three new drug reformulation projects, with two completing pharmacokinetic-based formulation studies and one planned for IND submission within the year [2]
一周医药速览(06.16-06.20)
Cai Jing Wang· 2025-06-20 08:17
Group 1 - Xiansheng Pharmaceutical has entered into a licensing agreement with NextCure for the ADC drug SIM0505, with a potential transaction value of up to $745 million [1] - SIM0505 targets CDH6 for the treatment of solid tumors, and NextCure will gain access to Xiansheng's TOPOi payload technology for its new ADC product in preclinical development [1] - The National Medical Products Administration has proposed a 30-day review process for innovative drug clinical trial applications to enhance the efficiency of drug development [1] Group 2 - Rongchang Biopharmaceutical's product Tai Tasi Pi has received orphan drug designation from the European Commission for the treatment of myasthenia gravis [2] - Myasthenia gravis is a rare autoimmune disease with a global prevalence of approximately 15-25 cases per 100,000 people [2] Group 3 - Shishi Pharmaceutical Group's caffeine has received the European Pharmacopoeia suitability certificate, facilitating its entry into the European and American markets [3] - The CEP certification indicates compliance with high standards for production processes and quality control, enhancing the brand's international image [3] Group 4 - Saintno Biopharmaceutical expects a significant increase in net profit for the first half of 2025, projecting a year-on-year growth of 253.54% to 332.10% [4] - The growth is attributed to the strong performance of its peptide raw material business and expanded marketing efforts [4]
整理:每日港股市场要闻速递(6月10日 周二)
news flash· 2025-06-10 01:12
3. 中国恒大(03333.HK)附属公司委任清盘人,股份自2024年1月29日星期一上午10时18分起暂停买卖, 并将继续停牌,直至另行通知。 4. 市场传闻称泡泡玛特(09992.HK)要进军AI玩具,泡泡玛特相关人士回应称:"没听说过"。 5. 一脉阳光(02522.HK):附属公司湖南一脉拟收购众雅诊断100%股权。 6. 亿纬锂能:拟发行 H 股股票并在香港联合交易所有限公司主板挂牌上市。 7. 龙湖集团(00960.HK)在港交所公告,5月实现总合同销售金额人民币64.7亿元,合同销售面积49.2万平 方米。 金十数据整理:每日港股市场要闻速递(6月10日 周二) 个股新闻: 1. 四环医药(00460.HK)吡洛西利片新增适应症的新药上市申请获受理。 2. 石四药集团(02005.HK):取得0.3ml马来酸噻吗洛尔滴眼液药品生产注册批件。 ...
港股午评|恒生指数早盘跌0.21% 有色板块涨幅居前
智通财经网· 2025-06-06 04:11
Market Overview - The Hang Seng Index fell by 0.21%, down 49 points, closing at 23,857 points, while the Hang Seng Tech Index decreased by 0.59% [1] - The early trading volume in the Hong Kong stock market reached HKD 102.1 billion [1] Sector Performance - The non-ferrous metal sector showed strong performance, with institutions optimistic about sustained profitability; Luoyang Molybdenum Co. rose by 4% and Jiangxi Copper Co. increased by 3.11% [1] - The three major telecom operators in Hong Kong experienced gains, with China Unicom, China Mobile, and China Telecom all rising over 2% [1] Notable Stock Movements - China Silver Group surged over 23%, with spot silver prices reaching nearly USD 36, marking a 13-year high [1] - Longpan Technology saw a rise of 3.35% after signing a large order for 150,000 tons of lithium iron phosphate, indicating a boost in solid-state battery production [1] - Dongyue Group increased by 1.54% as prices for third-generation refrigerants continued to rise, positioning the company as a leader in R22 and R32 quotas [1] - Youjia Innovation rose by 7% after securing a key model for a new energy brand under Changan Automobile [1] - Shijiazhuang Pharmaceutical Group increased by 4.27% after obtaining production registration for calcium gluconate and sodium chloride injection [1] - Zhongxu Future surged over 11% as the issuance of domestic game licenses reached a new high, with multiple new titles planned for release within the year [1] Company-Specific Challenges - Dongfeng Group's stock fell over 3% amid clarification from its controlling shareholder that there are no current restructuring plans, with a reported 17.1% year-on-year decline in vehicle sales for the first five months [2] - Alibaba Health dropped by 3.46% as its profits for the fiscal year 2025 fell short of expectations, with UBS suggesting the company may struggle to maintain its current valuation [3] - The automotive sector faced renewed declines, with analysts predicting an unavoidable new round of price wars, leading to a trend of increased revenue without profit growth; XPeng Motors fell by 2.9% and Li Auto decreased by 1.46% [3]