12月29日，又一药企复合磷酸氢钾注射液（膳维喜）获国家药监局批准上市，作为磷酸补充剂用于临床。这款年销超4亿元、同比增长27.3%的临床"硬通 货"，在持续增长的市场中迎来了又一位竞争者。 在这次获批前，国内已有24家药企拥有该品种的生产批文，其中19家已通过一致性评价，市场竞争格局已相当稳定。然而，申报热情不减。目前仍有15家药 企提交了3类仿制药上市申请，正处于审评审批的阶段。这反映出企业对该品种市场价值的持续看好。 截图来源：全终端医院销售数据库 截图来源：企业公告 复合磷酸氢钾注射液是临床纠正成人及儿童低磷血症的关键药物，尤其在患者无法经口补充时，是维持生命体征稳定的静脉磷钾"精准补给方案"。与常规营 养制剂不同，其定位于满足特定临床场景下的电解质精准补充，属于治疗性刚需。该品种被纳入国家医保乙类目录多年，临床认知与使用已高度成熟。 市场数据印证了其价值。据摩熵医药数据库显示，该品种近三年在全终端医院市场保持稳定增长，2024年销售额突破4亿元，同比增长27.3%，在血液代用 品与灌注液品类中稳居市场前列。此次获批，正值该市场处于明确的扩容时期。 | 按受理号浏览(13) | 按品种浏览(1) | ...

Core Viewpoint - The company, through its subsidiary Shuanghe Tianan Pharmaceutical, has received a GMP compliance inspection notice from the Guizhou Provincial Drug Administration, confirming that its production quality management meets GMP requirements, which is crucial for maintaining product quality and production capacity [1][4]. GMP Inspection Information - The inspected entity is Shuanghe Tianan Pharmaceutical, located in Guizhou, with the inspection conducted from October 15 to October 17, 2025, focusing on the production line for Metformin and Empagliflozin Tablets (I) [1][2]. - The production line has a designed capacity of 500 million tablets per year [2]. Product and Market Situation - Metformin and Empagliflozin Tablets (I) are used for improving blood sugar control in adults with type 2 diabetes and were developed by Boehringer Ingelheim, launched in the EU and the US in 2015, and in China in 2019 [2]. - The global sales for Metformin and Empagliflozin Tablets (I) are projected to reach $103 million in 2024, with the product "SYNJARDY" generating sales of approximately $43.31 million [2]. - In the Chinese market, there are 22 approved manufacturers for Metformin and Empagliflozin Tablets (I), with Shuanghe Tianan included, and the total sales in the domestic market are estimated at 341 million RMB in 2024 [3]. Impact on the Company - The successful GMP compliance inspection indicates that the company can maintain stable product quality and production capacity, which is essential for meeting market demand [4]. - The inspection results are not expected to have a significant impact on the company's financial performance [4].

Core Viewpoint - China Resources Double Crane Pharmaceutical (华润双鹤) announced that its subsidiary, Double Crane Tianan Pharmaceutical (贵州双鹤天安药业), received a GMP compliance inspection notice from the Guizhou Provincial Drug Administration, indicating regulatory approval for its production line [1] Group 1: Company Information - The subsidiary involved is Double Crane Tianan Pharmaceutical, which is located in Guizhou [1] - The production line is designed for the manufacturing of Metformin and Ertugliflozin tablets, with a capacity of 500 million tablets per year [1] Group 2: Regulatory Approval - The notice received is titled "Drug GMP Compliance Inspection Notice" with the reference number: 黔20250059 [1] - The inspection covered the tablet production line and related workshops, confirming compliance with GMP standards [1]

Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received a GMP compliance inspection notice from the Guizhou Provincial Drug Administration [1] Group 1: Company Developments - The inspection notice (No. 黔20250059) pertains to the production of Metformin and Ertugliflozin tablets (Ⅰ), with each tablet containing 500mg of Metformin Hydrochloride and 5mg of Ertugliflozin [1] - The production line involved in the inspection is designed with an annual capacity of 500 million tablets [1]

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]

Core Viewpoint - ST HuLuWa (605199.SH) has received approval from the National Medical Products Administration for the registration of two pharmaceutical products, indicating a significant advancement in its product pipeline and potential market opportunities in diabetes treatment [1] Group 1: Product Approval - The company has been granted a drug registration certificate for Metformin and Empagliflozin Tablets (I) and an inhalation solution of Compound Ipratropium Bromide, which reflects the company's commitment to expanding its therapeutic offerings [1] - Metformin and Empagliflozin Tablets (I) are indicated for use in conjunction with diet and exercise to improve blood sugar control in adult patients with type 2 diabetes who are already receiving treatment with Empagliflozin and Metformin Hydrochloride [1] - The approval was based on the evaluation of quality and efficacy consistent with the reference preparation, highlighting the company's adherence to regulatory standards [1]