石四药集团(02005)发布公告，集团已取得中国国家药品监督管理局有关新增2ml规格的复合磷酸氢钾注 射液的药品生产注册批件，属于化学药品第3类，视同通过一致性评价。复合磷酸氢钾注射液是复方制 剂，主要当口服或肠内营养无法进行、不足或有禁忌时，用于纠正成人和儿童患者的低磷血症及用于成 人和儿童患者的肠外营养。 ...

智通财经APP讯，石四药集团(02005)发布公告，集团已取得中国国家药品监督管理局有关新增2ml规格 的复合磷酸氢钾注射液的药品生产注册批件，属于化学药品第3类，视同通过一致性评价。复合磷酸氢 钾注射液是复方制剂，主要当口服或肠内营养无法进行、不足或有禁忌时，用于纠正成人和儿童患者的 低磷血症及用于成人和儿童患者的肠外营养。 ...

格隆汇1月26日丨石四药集团(02005.HK)公告，集团已取得中国国家药品监督管理局有关新增2ml规格的 复合磷酸氢钾注射液的药品生产注册批件，属于化学药品第3类，视同通过一致性评价。 复合磷酸氢钾注射液是复方制剂，主要当口服或肠内营养无法进行、不足或有禁忌时，用于纠正成人和 儿童患者的低磷血症及用于成人和儿童患者的肠外营养。 ...

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。 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。 - 1 - 石四藥集團有限公司(「本公司」，連同其附屬公司，「本集團」)董事局(「董事局」)欣然公告， 本集團已取得中國國家藥品監督管理局有關新增2ml 規格的複合磷酸氫鉀注射液的藥品生產註 冊批件，屬於化學藥品第3類，視同通過一致性評價。 複合磷酸氫鉀注射液是複方製劑，主要當口服或腸內營養無法進行、不足或有禁忌時，用於糾 正成人和兒童患者的低磷血症及用於成人和兒童患者的腸外營養。 本公告為本公司自願發佈，目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 承董事局命 執行董事兼公司秘書 周興揚 香港，二零二六年一月二十六日 自願公告 產品開發的最新進展 ...

Core Insights - A new potassium hydrogen phosphate injection (Shanweixi) has been approved for market release by the National Medical Products Administration, entering a growing market with annual sales exceeding 400 million yuan and a year-on-year growth of 27.3% [1][4]. Market Overview - The compound potassium hydrogen phosphate injection is crucial for correcting hypophosphatemia in adults and children, especially when oral supplementation is not feasible, serving as a vital intravenous electrolyte replenishment solution [4]. - The product has been included in the National Medical Insurance Category B for several years, indicating a mature clinical understanding and usage [4]. - Market data from the MoSheng Pharmaceutical Database shows stable growth over the past three years, with sales expected to exceed 400 million yuan in 2024, reflecting a 27.3% increase [4]. Competitive Landscape - Prior to this approval, 24 pharmaceutical companies already held production licenses for this product, with 19 having passed consistency evaluations, indicating a stable competitive landscape [6]. - Despite the existing competition, there remains strong interest, with 15 additional companies currently in the process of applying for generic drug approvals, highlighting ongoing optimism regarding the market value of this product [6][9]. Future Outlook - For new entrants in the pharmaceutical sector, despite facing significant competition, the continuous growth of the market size and clear clinical positioning still provide opportunities for market entry [9]. - As more companies join the market, competition is expected to intensify, which may enhance product accessibility and optimize clinical medication costs [12].

Core Viewpoint - Fosun Pharma's subsidiary has received approval from the National Medical Products Administration of China for the "Compound Potassium Hydrogen Phosphate Injection," which is intended as a phosphate supplement for patients unable to receive oral or enteral nutrition [1][2]. Group 1: Product Details - The "Compound Potassium Hydrogen Phosphate Injection" is primarily used for patients with hypophosphatemia and those requiring parenteral nutrition supplementation [1]. - This new generation phosphate-potassium compound formulation aims to quickly correct phosphate deficiency while stabilizing cell membrane potential through potassium supplementation, thereby preventing risks associated with hypophosphatemia such as rhabdomyolysis and arrhythmias [1]. - The product is classified as a Category B item by the National Healthcare Security Administration, highlighting its high safety profile, rapid absorption, dual phosphate-potassium supplementation, and alignment with multiple clinical guidelines [1]. Group 2: Market Potential - According to data from Minai Network, the domestic sales of the "Compound Potassium Hydrogen Phosphate Injection" are projected to be 343 million yuan in 2023 and 413 million yuan in 2024 [1]. - The launch of this product enhances the company's portfolio in the nutritional supplement treatment sector, providing more treatment options for adults and children suffering from hypophosphatemia and those needing parenteral phosphate supplementation [2].

Core Viewpoint - Fosen Pharmaceutical's subsidiary has received approval from the National Medical Products Administration of China for its "Compound Potassium Hydrogen Phosphate Injection," which is intended as a phosphate supplement for patients unable to receive oral or enteral nutrition [1][2] Group 1: Product Details - The "Compound Potassium Hydrogen Phosphate Injection" is primarily used for patients with hypophosphatemia and those requiring parenteral nutrition supplementation [1] - The product is a new generation phosphate-potassium compound formulation that quickly corrects phosphate deficiency while stabilizing cell membrane potential through potassium supplementation [1] - The domestic sales forecast for the injection is projected to be CNY 343 million in 2023 and CNY 413 million in 2024 [1] Group 2: Market Position and Benefits - The injection is classified as a Category B product by the National Healthcare Security Administration, highlighting its safety, rapid absorption, and dual phosphate-potassium supplementation [1] - The formulation is consistent with the reference original research product, ensuring quality control that meets or exceeds the original product standards [1] - The product offers significant risk-benefit advantages in improving laboratory results and clinical symptoms for both adult and pediatric patients with hypophosphatemia [1]

Core Viewpoint - Fosen Pharmaceutical's wholly-owned subsidiary has received approval from the National Medical Products Administration of China for the launch of "Compound Potassium Hydrogen Phosphate Injection," which is intended as a phosphate supplement for patients unable to receive oral or enteral nutrition [1][2] Group 1: Product Details - The "Compound Potassium Hydrogen Phosphate Injection" is primarily used for patients with hypophosphatemia and those requiring parenteral nutrition supplementation [1] - The product is a new generation phosphate-potassium compound formulation that quickly corrects phosphate deficiency while simultaneously stabilizing cell membrane potential to prevent risks associated with hypophosphatemia [1] - The domestic sales forecast for the injection is projected to be CNY 343 million in 2023 and CNY 413 million in 2024 [1] Group 2: Market Position and Benefits - The injection is classified as a Category B product by the National Healthcare Security Administration, highlighting its safety, rapid absorption, dual phosphate-potassium supplementation, and alignment with multiple clinical guidelines [1] - The formulation of the injection is consistent with the reference product, ensuring quality control that meets or exceeds the original product, thereby safeguarding patient safety [1] - The product offers significant risk-benefit advantages in improving laboratory results and clinical symptoms for both adult and pediatric patients with hypophosphatemia [1]

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 的 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，概不就因本公告全部 或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 Fusen Pharmaceutical Company Limited 福 森 藥 業 有 限 公 司 （於開曼群島註冊成立的有限公司） （股份代號：1652） 福森藥業有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」） 欣然宣佈，本集團之全資附屬公司嘉亨（ 珠海橫琴 ）醫藥科技有限公司研發的「複 合 磷 酸 氫 鉀 注 射 液」（ 商 標 ： 膳 維 喜 ）， 上 市 申 請 已 獲 得 中 國 國 家 藥 品 監 督 管 理 局 批准，批准作為磷酸補充劑。 「複合磷酸氫鉀注射液」主要用於治療當口服或腸內營養無法進行、不足或有禁忌 時，以腸外營養補充，或患有低磷血症的成人和兒童患者。作為新一代磷鉀複合 製劑，通過科學配比磷酸氫二鉀與磷酸二氫鉀，可快速糾正磷缺乏，同時鉀元素 的 同 步 補 充 可 穩 定 細 胞 ...

Group 1 - The core point of the article is that Tianyao Pharmaceutical (600488) announced the approval of its subsidiary Tianyao Heping for the injection of compound potassium hydrogen phosphate by the National Medical Products Administration, indicating that the product has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2 - The approval signifies a significant milestone for the company, enhancing its product portfolio in the pharmaceutical market [1] - The successful completion of the consistency evaluation may lead to increased market competitiveness and potential revenue growth for the company [1] - This development reflects the ongoing regulatory support for generic drugs in the industry, which may encourage further investments and innovations [1]