盐酸左沙丁胺醇雾化吸入溶液
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加速布局创新药,南新制药联合申报一创新药研发项目
Jing Ji Wang· 2025-10-14 01:50
Core Viewpoint - Nanjing New Pharmaceutical (688189.SH) has signed a joint application agreement with a medical research institution to apply for a national major science and technology project focused on innovative drug development for high-altitude environment-related brain edema and pulmonary hypertension [1] Group 1 - The collaboration aims to strengthen the company's leading position in the cardiovascular disease sector and enhance its innovative drug research and development capabilities [1] - The company plans to continue increasing its investment in innovative drug R&D to improve its competitiveness in this field [1] - As of the first half of 2025, the company's R&D investment reached 47.0095 million yuan, with several projects reaching critical milestones [1] Group 2 - Key projects include the Phase II clinical trial of a Class I innovative drug for diabetic nephropathy, which has completed subject enrollment and is now in the data collection and efficacy evaluation phase [1] - The modified new drug project for inhaled paramivir is currently undergoing Phase III clinical trials, with the clinical trial for drug concentration at the target site completed [1] - The oral lyophilized powder for treating acute ischemic stroke has received a clinical trial notification, and the nebulized solution of levalbuterol has passed on-site verification and has been accepted for market application [1] - Other projects, including acetaminophen mannitol injection, are also progressing in an orderly manner [1] Group 3 - The company is optimizing its product pipeline to leverage existing competitive advantages while exploring potential disease areas, which will enhance the resilience of its product pipeline and positively impact its performance [2] - This strategy is expected to lay a solid foundation for the company's long-term stable development [2]
南新制药联袂军科院 攻关高原脑水肿与肺动脉高压新药研发
Cai Fu Zai Xian· 2025-10-13 01:29
Core Viewpoint - Nanjing Pharmaceutical has signed a joint application agreement with the Military Medical Research Institute of the Chinese People's Liberation Army to apply for a major national science and technology project focused on innovative drug development for high-altitude environment-induced brain edema and pulmonary hypertension [1] Group 1: Collaboration and Strategic Initiatives - The collaboration with the Military Medical Research Institute will strengthen the company's leading position in the cardiovascular disease sector and enhance its innovative drug development capabilities [1] - The company plans to continue increasing its investment in innovative drug research and development to improve its competitiveness in the innovative drug field [1] Group 2: Research and Development Progress - In the first half of 2025, the company's R&D investment reached 47.0095 million yuan, with several projects reaching critical milestones [1] - Key projects include: - Phase II clinical trials for a first-class innovative drug, Mefenamic Acid Tablets, for diabetic nephropathy, which has completed subject enrollment and is entering the data collection and efficacy evaluation phase [1] - The modified new drug, Peramivir inhalation solution, is undergoing Phase III clinical trials, with clinical trials for drug concentration at the target site completed [1] - The oral lyophilized powder for stroke treatment, Dexamethasone, has officially received a clinical trial notification [1] - The nebulized solution of Levosalbutamol has passed on-site verification and completed the acceptance of the market application [1] - The development of projects like Acetaminophen Mannitol Injection is progressing in an orderly manner [1] Group 3: Product Pipeline Optimization - The company is optimizing its product pipeline to leverage existing competitive advantages in known disease areas while exploring potential disease areas, enhancing the resilience of its product pipeline [2] - This strategy is expected to positively impact the company's performance and lay a solid foundation for long-term stable development [2]
南新制药与军事科学院军事医学研究院联合申报创新药研发项目
Zheng Quan Ri Bao Wang· 2025-10-12 13:24
Core Insights - Hunan Nanxin Pharmaceutical Co., Ltd. has signed a joint application agreement with the Military Academy of Medical Sciences to apply for a national major science and technology project focused on innovative drug development for high-altitude environment-related conditions [1] - The collaboration aims to strengthen the company's leading position in the cardiovascular disease sector and enhance its innovative drug research and development capabilities [1] - The company plans to increase its investment in innovative drug development to boost its competitiveness in this field [1] Research and Development Progress - In the first half of 2025, the company's R&D investment reached 47.0095 million yuan, with several projects reaching critical milestones [1] - The clinical trial for the innovative drug Meifluorine Hydrochloride Tablets for diabetic nephropathy has completed participant enrollment and is now in the data collection and efficacy evaluation phase [1] - The modified new drug Palivizumab inhalation solution is undergoing Phase III clinical trials, and the first-line stroke treatment drug Difenpyramine oral lyophilized powder has received clinical trial notification [1] - The project for Levosalbutamol nebulized inhalation solution has passed on-site verification and completed the acceptance of market application [1] - Other projects, including Acetaminophen Mannitol Injection, are progressing in an orderly manner [1] Product Pipeline Optimization - The company is optimizing its product pipeline to leverage existing competitive advantages while exploring potential disease areas, which will enhance the resilience of its product pipeline [2] - This strategy is expected to positively impact the company's performance and lay a solid foundation for long-term stable development [2]
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
Core Viewpoint - The company Shijiazhuang Pharmaceutical Group has received production registration approvals from the National Medical Products Administration for seven pharmaceutical products, indicating a significant advancement in its product portfolio and market positioning [1]. Group 1: Product Approvals - The company has obtained approvals for the following products: 1. Arginine Perindopril Tablets (10mg), classified as a Class 4 chemical drug, is the second domestic company to receive approval, primarily used for treating hypertension and congestive heart failure [1]. 2. Progesterone Injection (II) (1.112ml:25mg), classified as a Class 3 chemical drug, is used for progesterone supplementation in assisted reproductive technology (ART) [1]. 3. Labetalol Hydrochloride Injection (20ml:100mg), classified as a Class 3 chemical drug, is used for various types of hypertension, especially hypertensive crises, and for blood pressure control before surgery [1]. 4. Calcium Chloride Injection (10ml:1g), classified as a Class 3 chemical drug, is primarily used for treating acute hypocalcemia and magnesium poisoning [1]. 5. Compound Electrolyte Acetate Injection (500ml), classified as a Class 3 chemical drug, is used for treating isotonic dehydration with mild acidosis and for replenishing extracellular fluid and blood volume loss [1]. 6. Compound Electrolyte Injection (V) (500ml), classified as a Class 3 chemical drug, serves as a source of water and electrolytes for adults [1]. 7. Levosalbutamol Hydrochloride Nebulization Solution (3ml:0.63mg), classified as a Class 3 chemical drug, is used for treating or preventing bronchospasm in adults and children over six years old with reversible airway obstructive diseases [1].
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
Core Viewpoint - The company, Shijiazhuang Pharmaceutical Group, has received production registration approvals from the National Medical Products Administration for seven pharmaceutical products, indicating a significant advancement in its product portfolio and market positioning [1]. Group 1: Product Approvals - The company has obtained approvals for the following seven drugs: 1. Arginine Perindopril Tablets (10mg), classified as a Class 4 chemical drug, is the second domestic company to receive approval, primarily used for treating hypertension and congestive heart failure [1]. 2. Progesterone Injection (II) (1.112ml: 25mg), classified as a Class 3 chemical drug, is used for progesterone supplementation in assisted reproductive technology (ART) [1]. 3. Labetalol Hydrochloride Injection (20ml: 100mg), classified as a Class 3 chemical drug, is indicated for various types of hypertension, especially hypertensive crises, and for blood pressure control before surgery [1]. 4. Calcium Chloride Injection (10ml: 1g), classified as a Class 3 chemical drug, is primarily used for treating acute hypocalcemia and magnesium poisoning [1]. 5. Compound Electrolyte Acetate Injection (500ml), classified as a Class 3 chemical drug, is used for treating isotonic dehydration with mild acidosis and for replenishing extracellular fluid and blood volume loss [1]. 6. Compound Electrolyte Injection (V) (500ml), classified as a Class 3 chemical drug, serves as a source of water and electrolytes for adults [1]. 7. Levosalbutamol Nebulization Solution (3ml: 0.63mg), classified as a Class 3 chemical drug, is used for treating or preventing bronchospasm in adults and children over 6 years old with reversible airway obstructive diseases [1].
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
Core Viewpoint - The company has submitted a marketing application for its nebulized solution of Levosalbutamol and has passed the on-site inspection, aiming for an early market launch [1] Group 1 - The company responded to an investor inquiry regarding which research and development project is closest to market launch [1] - The company is actively following up on the application status and is committed to bringing the product to market as soon as possible [1]
南新制药创新研发多线突破 全域营销提质增效
Zheng Quan Ri Bao Zhi Sheng· 2025-08-28 13:40
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
Shang Hai Zheng Quan Bao· 2025-08-13 01:35
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].