SSY GROUP(02005)
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格隆汇公告精选(港股)︱荣昌生物(09995.HK):泰它西普(商品名:泰爱®)治疗原发性乾燥综合征中国III期临床研究达到主要终点
Ge Long Hui· 2025-08-14 14:59
Group 1: Core Insights - Rongchang Biologics (09995.HK) announced that its innovative drug Taitasip (brand name: Tai Ai®) for treating primary Sjögren's syndrome has met the primary endpoint in a Phase III clinical trial in China [1] - Taitasip is the first BLyS/APRIL dual-target fusion protein drug to complete Phase III research in the field of Sjögren's syndrome globally [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taitasip, with the primary endpoint being the change in ESSDAI score at week 24 compared to baseline [1] Group 2: Disease Background and Drug Mechanism - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [2] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend indicating a significant unmet clinical need [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of BLyS and APRIL, effectively preventing abnormal differentiation and maturation of B cells [2] Group 3: Regulatory and Clinical Recognition - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B-cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taitasip has been granted Fast Track designation by the U.S. FDA for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]
石四药集团(02005.HK):阿齐沙坦获国家药监局批准登记成为在上市制剂使用的原料药
Ge Long Hui· 2025-08-14 08:49
Core Viewpoint - The approval of Azilsartan by the National Medical Products Administration of China marks a significant milestone for the company, as it can now be used as an active pharmaceutical ingredient in marketed formulations [1] Company Summary - The company, Stone Four Pharmaceutical Group, has received regulatory approval for Azilsartan, an angiotensin II receptor blocker (ARB) [1] - Azilsartan is primarily used for the treatment of hypertension by blocking the effects of angiotensin II to lower blood pressure [1]
石四药集团(02005):阿齐沙坦已获国家药监局批准登记成为在上市制剂使用的原料药
智通财经网· 2025-08-14 08:46
Core Viewpoint - The approval of Azilsartan by the National Medical Products Administration of China marks a significant milestone for the company, allowing it to be used as an active pharmaceutical ingredient in marketed formulations [1] Company Summary - The company, Stone Four Pharmaceutical Group, has received regulatory approval for Azilsartan, which is classified as an angiotensin II receptor blocker (ARB) [1] - Azilsartan is primarily indicated for the treatment of hypertension by blocking the effects of angiotensin II to lower blood pressure [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-08-14 08:31
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,二零二五年八月十四日 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, 本集團的阿齊沙坦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。阿齊 沙坦是一種血管緊張素 II 受體拮抗劑(ARB),通過阻斷血管緊張素 II 的作用而降低血壓,主 要用於治療高血壓。 ...
石四药集团(02005.HK):氨吡啶已获国家药监局批准登记成为在上市制剂使用的原料药
Ge Long Hui· 2025-08-13 08:44
Core Viewpoint - The announcement highlights that Stone Four Pharmaceutical Group has received approval from the National Medical Products Administration of China for its Amaprine to be registered as an active pharmaceutical ingredient for use in marketed formulations, making it the first company in the country to achieve this [1] Company Summary - Stone Four Pharmaceutical Group's Amaprine is a potassium channel blocker primarily used to improve walking speed in adults with certain types of multiple sclerosis [1]
石四药集团:氨吡啶已获国家药监局批准登记成为在上市制剂使用的原料药
Zhi Tong Cai Jing· 2025-08-13 08:41
Core Viewpoint - The announcement indicates that Shijiazhuang Pharmaceutical Group has received approval from the National Medical Products Administration of China for its Amaprine to be used as an active pharmaceutical ingredient in marketed formulations, making it the first company in the country to achieve this approval [1] Group 1 - Shijiazhuang Pharmaceutical Group's Amaprine is a potassium channel blocker [1] - Amaprine is primarily used to improve walking speed in adults with certain types of multiple sclerosis [1]
石四药集团(02005):氨吡啶已获国家药监局批准登记成为在上市制剂使用的原料药
智通财经网· 2025-08-13 08:40
Core Viewpoint - The company Shijiazhuang Fourth Pharmaceutical Group has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredient, Amaprine, marking it as the first in the country to be approved for use in marketed formulations [1] Group 1 - Amaprine is a potassium channel blocker primarily used to improve walking speed in adults with certain types of multiple sclerosis [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-08-13 08:30
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。 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。 自願公告 產品開發的最新進展 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, 本集團的氨吡啶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,是國內 首家獲批。氨吡啶是一種鉀通道阻滯劑,主要用於改善某些多發性硬化症成年人步行速度。 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,二零二五年八月十三日 ...
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]