上述两款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。 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。吸入用复方异丙托溴铵溶液适应症为适用于需 要多种支气管扩张剂联合应用的患者，用于治疗气道阻塞性疾病有关的可逆性支气管痉挛。 人民财讯9月1日电，ST葫芦娃（605199）9月1日晚间公告，公司近日收到国家药监局核准签发的关于 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》。 ...

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。 ...

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]