盐酸氨溴索

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石四药集团(02005.HK):盐酸氨溴索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· 2025-09-15 08:48
Group 1 - The core point of the article is that Shijiazhuang Pharmaceutical Group (02005.HK) has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredient, Ambroxol Hydrochloride, to be used in marketed formulations. Ambroxol Hydrochloride is an expectorant primarily used for treating respiratory diseases [1] - The company also announced that it has obtained production registration approvals for Calcium Gluconate and Sodium Chloride Injection (100ml:1g/0.8g) and Metronidazole Sodium Chloride Injection (100ml:0.5g/0.9g) [1]
石四药集团:盐酸氨溴索获批准登记成为在上市制剂使用的原料药
Zhi Tong Cai Jing· 2025-09-15 08:44
石四药集团(02005)发布公告,集团的盐酸氨溴索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。盐酸氨溴索是一种祛痰药,主要用于治疗呼吸道疾病。 ...
石四药集团(02005):盐酸氨溴索获批准登记成为在上市制剂使用的原料药
智通财经网· 2025-09-15 08:39
智通财经APP讯,石四药集团(02005)发布公告,集团的盐酸氨溴索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。盐酸氨溴索是一种祛痰药,主要用于治疗呼吸道疾病。 ...
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-09-15 08:34
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。 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, 本集團的鹽酸氨溴索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。 鹽酸氨溴索是一種祛痰藥,主要用於治療呼吸道疾病。 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,二零二五年九月十五日 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。 自願公告 產品開發的最新進展 ...
仿制药追赶原研药:一致性评价不可沦为“一次性评价”
Xin Hua Wang· 2025-08-12 05:38
Core Viewpoint - The increase in mycoplasma infections leading to pneumonia has raised concerns about the choice between generic and original drugs, with a focus on the effectiveness and quality of these medications [1] Group 1: Differences Between Generic and Original Drugs - Patients are increasingly accepting domestic generic drugs, but some still prefer original drugs, especially in critical situations [2] - Differences in drug absorption and effectiveness are attributed to individual body responses and the physical characteristics of the drugs, such as different crystal forms [2] - Variations in manufacturing processes and excipients used by generic drug manufacturers can lead to differences in taste and efficacy compared to original drugs [3] Group 2: Regulatory and Quality Standards - China has a high proportion of generic drugs, with over 95% of approved chemical drugs being generics [4] - The implementation of consistency evaluation standards has improved the quality of generic drugs, allowing them to compete more effectively with original drugs [5] - The consistency evaluation is seen as a starting point for ensuring drug quality, with ongoing monitoring necessary to prevent it from becoming a one-time assessment [6] Group 3: Challenges in Quality Assurance - Some manufacturers may alter packaging or excipients post-evaluation to reduce costs, which could impact drug quality and efficacy [6] - There are concerns about the validity of stability studies when extending the shelf life of generic drugs, as some may not follow proper protocols [7] - Regulatory bodies are enhancing oversight to ensure that the quality and efficacy of generic drugs remain consistent with original drugs [7]
科伦药业(002422):一季度业绩承压 全年季度环比望迎改善
Xin Lang Cai Jing· 2025-05-05 08:37
Core Viewpoint - The company reported mixed financial results for 2024 and Q1 2025, with a slight increase in annual revenue but a significant decline in quarterly performance due to high base effects from the previous year [1][2]. Financial Performance - In 2024, the company achieved operating revenue of 21.812 billion yuan, a year-on-year increase of 1.67%, and a net profit attributable to shareholders of 2.936 billion yuan, up 19.53% [1]. - For Q1 2025, the company reported operating revenue of 4.390 billion yuan, a year-on-year decrease of 29.42%, and a net profit of 584 million yuan, down 43.07% [2]. Profitability Metrics - The overall gross margin for 2024 was 51.69%, a decrease of 0.74 percentage points year-on-year, while the expense ratio was 32.27%, down 3.95 percentage points [3]. - In Q1 2025, the gross margin dropped to 48.67%, a decline of 7.17 percentage points year-on-year, with the expense ratio slightly increasing to 32.38% [3]. Business Segments - The infusion business generated sales of 8.912 billion yuan in 2024, a decrease of 11.85%, with sales volume of 4.347 billion bottles/bags, down 0.70% [4]. - Non-infusion drug sales increased by 5.41% to 4.169 billion yuan, driven by strong performance in the plastic water needle business [4]. - The antibiotic intermediates and raw materials segment achieved revenue of 5.856 billion yuan, a year-on-year increase of 20.90%, benefiting from increased market demand [4]. Innovation and Pipeline - The company launched its innovative drug, Lukanosatuzumab (佳泰莱), in November 2024, marking the beginning of a new era in innovative drug commercialization [5]. - Ongoing clinical trials for various ADC therapies are being conducted in collaboration with Merck, targeting multiple cancer types [5][6]. Future Projections - Revenue projections for 2025 to 2027 are estimated at 21.9 billion, 23.36 billion, and 23.98 billion yuan, with corresponding net profits of 3.02 billion, 3.35 billion, and 3.41 billion yuan [7]. - The company is expected to maintain a valuation of 19X for 2025 and 17X for 2026 and 2027 [7]. Investment Rating - The investment rating is maintained at "Buy" based on the company's growth potential and ongoing innovation efforts [8].