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玻璃酸钠滴眼液成功获批,扬州中宝药业眼科管线再添新动力
Cai Fu Zai Xian· 2025-11-05 03:51
Core Insights - The National Medical Products Administration has approved the sodium hyaluronate eye drops submitted by Yangzhou Zhongbao Pharmaceutical Co., Ltd, enhancing the company's product pipeline in the ophthalmology sector [1][2] - Sodium hyaluronate is a natural polysaccharide known for its excellent moisture retention and lubrication properties, addressing the increasing prevalence of dry eye symptoms due to heightened screen time and electronic device usage [1] - The approval of this product not only provides a reliable solution for the domestic eye medication market but also offers consumers a convenient and safe option for self-medication [1] Company Overview - Yangzhou Zhongbao Pharmaceutical is a comprehensive pharmaceutical enterprise engaged in research and development, production, and marketing, with a product range covering cardiovascular, respiratory, ophthalmology, and health sectors [1] - The company has established a diversified R&D system, including innovative drug development, inhalation formulation technology platforms, and ophthalmic drug research platforms, showcasing its continuous innovation capabilities [1] - The company has received over 20 invention patent authorizations and has more than 30 ongoing projects, reflecting its robust innovation vitality [1] Recent Developments - In the past two years, Yangzhou Zhongbao Pharmaceutical has entered a concentrated harvest period for R&D achievements, with multiple new products successfully launched or passing the consistency evaluation for generic drugs [2] - The sodium hyaluronate eye drops are not the only product approved this year; the company has also received approvals for six other products, including inhalation solutions and injection liquids, demonstrating strong product pipeline development and continuous innovation [2] - Looking ahead, the company plans to leverage this product approval to increase R&D investment, optimize product structure, and develop more high-quality drugs that meet clinical and market needs, contributing to the "Healthy China" initiative [2]
ST葫芦娃:两款药品获得药品注册证书
Core Viewpoint - ST HuLuWa has received approval from the National Medical Products Administration for two new drug registrations, indicating a significant advancement in its product pipeline and potential market opportunities in diabetes and respiratory disease treatments [1] Group 1: Drug Approvals - The company has obtained drug registration certificates for Metformin and Empagliflozin Tablets (I) and Inhaled Compound Ipratropium Bromide Solution [1] - Metformin and Empagliflozin Tablets (I) are indicated for adult patients with type 2 diabetes, aimed at improving blood sugar control when used alongside diet and exercise [1] - The inhaled compound solution is intended for patients requiring multiple bronchodilators for the treatment of reversible bronchospasm associated with obstructive airway diseases [1] Group 2: Regulatory Compliance - Both drugs were approved based on the technical requirements for quality and efficacy consistency with reference preparations, which aligns with the standards for generic drug quality and efficacy evaluation [1]
ST葫芦娃(605199.SH):二甲双胍恩格列净片(Ⅰ)获得药品注册证书
Ge Long Hui A P P· 2025-09-01 09:20
格隆汇9月1日丨ST葫芦娃(605199.SH)公布,公司近日收到国家药品监督管理局核准签发的关于二甲双 胍恩格列净片(Ⅰ)、吸入用复方异丙托溴铵溶液的《药品注册证书》。二甲双胍恩格列净片(Ⅰ)适 应症为配合饮食控制和运动,适用于正在接受恩格列净和盐酸二甲双胍治疗的2型糖尿病成人患者,用 于改善这些患者的血糖控制。该药品按照与参比制剂质量和疗效一致的技术要求审评并获批,批准后视 同通过仿制药质量和疗效一致性评价。 ...
ST葫芦娃:获得药品注册证书
Xin Lang Cai Jing· 2025-09-01 09:12
ST葫芦娃公告,公司近日收到国家药品监督管理局核准签发的关于二甲双胍恩格列净片(Ⅰ)和吸入 用复方异丙托溴铵溶液的《药品注册证书》。其中,二甲双胍恩格列净片(Ⅰ)已累计投入研发费用 1160.07万元,吸入用复方异丙托溴铵溶液已累计投入研发费用316.96万元。 ...
津药药业:“原料药+制剂”一体化,产品矩阵持续丰富
Quan Jing Wang· 2025-04-30 10:12
Core Viewpoint - Tianjin Pharmaceutical Industry is recognized as a leading domestic manufacturer of steroid hormone drugs and a global leader in amino acid raw materials, showcasing its advanced position and demonstration effect in the industry for the year 2024 [1] Product Matrix - The company has a diverse product matrix with over 70 types of raw materials, including dexamethasone series, prednisone series, methylprednisolone series, betamethasone series, and amino acids, as well as more than 10 dosage forms such as injections, ointments, and tablets, catering to various patient treatment needs [2] R&D Innovation - In recent years, the company has significantly enhanced its product R&D and scientific research system, focusing on steroid hormones and amino acids, and implementing a "raw materials + formulations" full industry chain layout, with R&D investment reaching 248 million yuan in 2024, accounting for 7.7% of revenue, reflecting its strong R&D capabilities [3] Dual-Track Strategy - The company employs a dual-track strategy of "innovation line" and "generic line" to accelerate the new drug approval process, with 11 specifications of 10 products recently receiving approval, including the first domestic approval for a specific injection by its subsidiary [4] Market Performance - Among its products, the injection of isopropyl methochloride has shown strong market performance, with sales increasing from 756 million yuan in 2022 to 821 million yuan in 2023, and is expected to expand further due to its inclusion in the national medical insurance [5] - The inhalation solution of acetylcysteine is also a national medical insurance drug, with significant market potential in treating respiratory diseases, indicating a stable growth outlook as the patient population expands [5] Future Outlook - The company plans to continue its commitment to innovation, increasing investment in technology R&D, and focusing on new product development and consistency evaluation to provide high-quality, efficient drugs for patients and deliver substantial value returns to shareholders [6]