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石四药集团取得国家药监局共7个药品的药品生产注册批件
Zhi Tong Cai Jing· 2025-09-05 08:44
石四药集团(02005)发布公告,集团已取得国家药监局有关下列共7个药品的药品生产注册批件: (1)精氨酸培哚普利片(10mg),属于化学药品第4类,视同通过一致性评价,是国内企业第二家获批。精 氨酸培哚普利片主要用于治疗高血压与充血性心力衰竭; (2)黄体酮注射液(Ⅱ)(1.112ml:25mg),属于化学药品第3类,视同通过一致性评价。黄体酮注射液主要用 于辅助生殖技术(ART)中黄体酮的补充治疗; (3)盐酸拉贝洛尔注射液(20ml:100mg),属于化学药品第3类,视同通过一致性评价。盐酸拉贝洛尔注射 液主要用于各种类型高血压(尤其是高血压危象)的治疗、外科手术前控制血压、嗜铬细胞瘤的降压治疗 及妊娠高血压; (5)复方电解质醋酸钠注射液(500ml),属于化学药品第3类,视同通过一致性评价。复方电解质醋酸钠注 射液主要用于治疗伴随或预期出现轻度酸中毒的等渗性脱水,补充细胞外液和血容量的丢失; (6)复方电解质注射液(V)(500ml),属于化学药品第3类,视同通过一致性评价。复方电解质注射液主要 用于成人作为水、电解质的补充源和硷化剂;及 (7)盐酸左沙丁胺醇雾化吸入溶液(3ml:0.63mg),属 ...
石四药集团(02005.HK):精氨酸培哚普利片等7个药品获药品生产注册批件
Ge Long Hui· 2025-09-05 08:42
格隆汇9月5日丨石四药集团(02005.HK)发布公告,集团已取得国家药监局有关下列共7个药品的药品生 产注册批件: (6)复方电解质注射液(V) (500ml),属于化学药品第3类,视同通过一致性评价。复方电解质注射液主要 用于成人作为水、电解质的补充源和硷化剂;及 (1)精氨酸培哚普利片(10mg),属于化学药品第4类,视同通过一致性评价,是国内企业第二家获批。精 氨酸培哚普利片主要用于治疗高血压与充血性心力衰竭; (2)黄体酮注射液(Ⅱ) (1.112ml: 25mg),属于化学药品第3类,视同通过一致性评价。黄体酮注射液主要 用于辅助生殖技术(ART)中黄体酮的补充治疗; (4)氯化钙注射液(10ml: 1g),属于化学药品第3类,视同通过一致性评价。氯化钙注射液主要治疗急性低 钙血症及镁中毒; (5)复方电解质醋酸钠注射液(500ml),属于化学药品第3类,视同通过一致性评价。复方电解质醋酸钠注 射液主要用于治疗伴随或预期出现轻度酸中毒的等渗性脱水,补充细胞外液和血容量的丢失; (3)盐酸拉贝洛尔注射液(20ml: 100mg),属于化学药品第3类,视同通过一致性评价。盐酸拉贝洛尔注射 液主要用于各 ...
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2025-09-05 08:31
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。 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。 (6) 複方電解質注射液(V) (500ml),屬於化學藥品第3類,視同通過一致性評價。複方電解質注 射液主要用於成人作為水、電解質的補充源和鹼化劑;及 (7) 鹽酸左沙丁胺醇霧化吸入溶液(3ml: 0.63mg),屬於化學藥品第3類,視同通過一致性評價。 鹽酸左沙丁胺醇霧化吸入溶液主要用於治療或預防成人及6歲以上兒童可逆性氣道阻塞性 疾病引起的支氣管痙攣。誠如本公司日期為二零二三年九月四日之公告所載,本集團的鹽 酸左沙丁胺醇原料藥已獲國家藥監局批准登記成為在上市製劑使用的原料藥。 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 ...
公司问答丨南新制药:公司盐酸左沙丁胺醇雾化吸入溶液项目已提交上市申请并通过现场核查
Ge Long Hui A P P· 2025-09-01 09:50
格隆汇9月1日|有投资者在互动平台向南新制药提问:公司哪个研发项目离上市最近呢? 南新制药回应称,公司盐酸左沙丁胺醇雾化吸入溶液项目已经提交上市申请并通过现场核查,公司将及 时跟进申报情况,力争相关产品早日实现上市,后续进展情况请关注公司相关信息。 ...
南新制药创新研发多线突破 全域营销提质增效
Core Insights - Hunan Nanxin Pharmaceutical Co., Ltd. has reported significant advancements in its 2025 semi-annual report, highlighting a multi-dimensional breakthrough in "R&D + marketing + efficiency" amidst the accelerated integration and deep policy transformation in the pharmaceutical industry [1] Group 1: R&D Developments - The company has increased its investment in new drug research and development, with R&D expenditure reaching 47.0095 million yuan in the first half of 2025 [1] - Key projects have reached critical stages, including the phase II clinical trial of a novel drug for diabetic nephropathy, which has completed subject enrollment and is now in the data collection and efficacy evaluation phase [1] - The phase III clinical trial for the modified new drug, Palivizumab inhalation solution, is underway, and the application for the nebulized solution of Levosalbutamol has been accepted [1] Group 2: Marketing and Sales Channels - The company has established an online e-commerce marketing team, successfully achieving a breakthrough in sales from 0 to 1 on e-commerce platforms [2] - In the outpatient channel, innovative business models have been piloted in Guangdong Province, enhancing coverage of secondary and tertiary terminals [2] - A diversified national marketing network has been constructed, significantly improving the response speed of end customers [2] Group 3: Internal Management and Cost Efficiency - The company has implemented optimization across the entire supply chain for material procurement, achieving domestic production of key auxiliary materials [2] - Cost management has been refined through smart path algorithms and dynamic pricing mechanisms, effectively reducing logistics and warehousing costs [2] - Upgrades to inefficient and high-energy-consuming equipment have been completed, leading to significant improvements in production efficiency [2] Group 4: Future Outlook - For the second half of 2025, the company plans to align closely with national pharmaceutical policies, continuing to increase investment in innovative drug R&D and advancing multiple pipelines simultaneously [2] - The company aims to expand through the acquisition of drug approval licenses and external collaborations [2]
湘江新动能 | 华纳药厂:仿创结合,差异化发展
Core Insights - The article highlights the transformation journey of Warner Pharmaceutical from a generic drug manufacturer to an innovative pharmaceutical company, focusing on niche markets such as depression and rare animal medicine substitutes [3][10]. Company Overview - Warner Pharmaceutical, established in 2001, has evolved through three decades: from inception to growth, and now to a leading innovative pharmaceutical enterprise in China [4]. - The company reported a revenue of 14.13 billion yuan in 2024, with a 20.34% year-on-year increase from its manufacturing subsidiary [4][11]. R&D Investment - In 2024, Warner Pharmaceutical invested 1.58 billion yuan in R&D, accounting for over 11% of its revenue, which is significantly higher than the industry average of 8.2% [11]. - Cumulatively, the company has invested over 4.8 billion yuan in R&D from 2020 to 2024, with a 53.45% increase in R&D spending compared to the previous year [11]. Product Development Strategy - The company employs a "product cluster development" strategy, focusing on integrated raw material and formulation advantages, particularly in respiratory and anti-infection products [5][8]. - Warner Pharmaceutical has nearly 80 drug registration approvals, with over 50 raw material products transitioned to market-ready status [5]. New Projects and Facilities - The company is developing a high-end raw material drug project aimed at enhancing its competitive strength and production capabilities, aligning with international standards [7]. - The new facility is expected to improve automation and smart manufacturing, creating conditions for the industrialization of high-end generic and innovative drugs [7]. Innovation and Market Position - Warner Pharmaceutical has been recognized in the top 100 of China's chemical drug R&D strength rankings, reflecting its commitment to innovation [9]. - The company is focusing on niche areas for innovative drug development, avoiding crowded markets like anti-tumor drugs, and is exploring new fields such as endangered animal medicine substitutes [10].