FUSEN PHARM(01652)
Search documents
福森药业(01652):“复合磷酸氢钾注射液”获批上市
智通财经网· 2025-12-29 04:25
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]
福森药业(01652.HK):"复合磷酸氢钾注射液"获批上市
Ge Long Hui· 2025-12-29 04:22
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]
福森药业(01652) - 自愿公告「复合磷酸氢钾注射液」获批上市
2025-12-29 04:16
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 ...
福森药业:中正天恒获委任为新任核数师
Zhi Tong Cai Jing· 2025-12-24 09:25
Core Viewpoint - Fosun Pharma (01652) announced the resignation of KPMG as its auditor due to a failure to reach an agreement on the proposed audit fees for the fiscal year ending December 31, 2025 [1] Group 1 - The resignation of KPMG will be effective from December 24, 2025 [1] - Zhongzheng Tianheng Accounting Firm has been appointed as the new auditor to fill the vacancy left by KPMG, effective from December 24, 2025 [1] - The term of the new auditor will last until the conclusion of the next annual general meeting of the company [1]
福森药业(01652):中正天恒获委任为新任核数师
Zhi Tong Cai Jing· 2025-12-24 09:17
Group 1 - The company, Fosen Pharmaceutical (01652), announced that it has terminated its auditor, KPMG, due to a failure to reach an agreement on the proposed audit fees for the fiscal year ending December 31, 2025 [1] - Zhongzheng Tianheng Accounting Firm has been appointed as the new auditor to fill the vacancy left by KPMG, effective from December 24, 2025, until the conclusion of the next annual general meeting [1]
福森药业(01652.HK)委任中正天恒为公司新任核数师
Ge Long Hui· 2025-12-24 09:09
Group 1 - The core point of the article is that Fosen Pharmaceutical (01652.HK) announced the resignation of KPMG as the company's auditor due to a failure to reach an agreement on the proposed audit fees for the financial year ending December 31, 2025 [1] - The board has appointed Zhongzheng Tianheng as the new auditor to fill the vacancy left by KPMG, effective from December 24, 2025, until the conclusion of the next annual general meeting [1]
福森药业(01652) - 核数师变动
2025-12-24 09:03
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。 本公司董事(「董事」)會(「董事會」)宣佈,由於董事會與畢馬威會計師事務所(「畢 馬威」)未能就本集團截至2025年12月31日止財政年度綜合財務報表的建議審核費 用達成共識,故畢馬威已辭任本公司核數師,自2025年12月24日起生效。 本公司根據開曼群島法律註冊成立,據董事會所知,開曼群島法律並無規定退任 核數師確認是否有任何情況因其退任而致使其認為應提請本公司股東(「股東」)垂 注。因此,畢馬威並無出具有關確認函。董事會及本公司審核委員會(「審核委員 會」)確認,除上文披露者外,畢馬威與本公司之間概無意見分歧,亦無其他有關 上述核數師辭任的事宜或狀況須提請股東垂注。 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) 核數師 ...
福森药业:“盐酸尼卡地平注射液”一致性评价申请获批上市
Zhi Tong Cai Jing· 2025-12-12 12:54
Core Viewpoint - Fosen Pharmaceutical has received approval from the National Medical Products Administration of China for its "Nicardipine Hydrochloride Injection," which is intended for emergency treatment of abnormal hypertension during surgery and hypertensive emergencies [1][2] Group 1: Product Approval and Market Potential - The approval of Nicardipine Hydrochloride Injection is significant as it is recommended in various hypertension management guidelines, including the 2020 International Society of Hypertension's Global Hypertension Practice Guidelines and the Chinese Hypertension Emergency Diagnosis and Treatment Guidelines [1][2] - The sales scale of Nicardipine Hydrochloride Injection in Chinese public medical institutions is projected to exceed 600 million RMB in 2024, with a double-digit growth rate from 2022 to 2024, showing year-on-year increases of 35.71%, 16.09%, and 14.14% respectively [1] Group 2: Product Advantages and Market Position - Nicardipine Hydrochloride Injection is characterized by rapid onset, stable blood pressure reduction, and comprehensive organ protection, with non-toxic metabolites and enhanced vascular selectivity, making it safer for patients [2] - Fosen Pharmaceutical offers a complete range of specifications for Nicardipine Hydrochloride Injection, including 5ml:5mg, 2ml:2mg, and 10ml:10mg, catering to diverse patient treatment needs and achieving high market recognition [2] - The quality and efficacy of Fosen Pharmaceutical's Nicardipine Hydrochloride Injection are consistent with reference formulations, allowing it to serve as a substitute for the original drug in clinical settings [2]
福森药业(01652.HK):”盐酸尼卡地平注射液“一致性评价申请获批上市
Ge Long Hui· 2025-12-12 12:51
Core Viewpoint - Fosen Pharmaceutical has received approval from the National Medical Products Administration of China for its product, Nicardipine Hydrochloride Injection, which is intended for the emergency management of abnormal hypertension during surgery and hypertensive emergencies [1][2] Group 1: Product Approval and Market Potential - The consistency evaluation application for Nicardipine Hydrochloride Injection has been approved, indicating its readiness for clinical use [1] - The sales scale of Nicardipine Hydrochloride Injection in Chinese public medical institutions is projected to exceed 600 million RMB in 2024, with a double-digit growth rate expected from 2022 to 2024, showing year-on-year increases of 35.71%, 16.09%, and 14.14% respectively [1] - The product is recognized as a first-line treatment in various hypertension management guidelines, including the 2020 International Society of Hypertension's Global Hypertension Practice Guidelines and the Chinese Hypertension Emergency Diagnosis and Treatment Guidelines [1] Group 2: Product Advantages and Specifications - Nicardipine Hydrochloride Injection is noted for its rapid onset, stable blood pressure reduction, and comprehensive organ protection, with a non-toxic metabolic profile and enhanced vascular selectivity [2] - The company has been selling the 5ml:5mg specification in the domestic market for several years, achieving high market recognition, and has also received approval for additional specifications of 2ml:2mg and 10ml:10mg [2] - Fosen Pharmaceutical is one of the few companies in China to offer a complete range of specifications for Nicardipine Hydrochloride Injection, catering to diverse patient treatment needs [2]
福森药业(01652):“盐酸尼卡地平注射液”一致性评价申请获批上市
智通财经网· 2025-12-12 12:49
Core Viewpoint - Fosen Pharmaceutical has received approval from the National Medical Products Administration of China for its "Nicardipine Hydrochloride Injection," which is intended for the emergency management of abnormal hypertension during surgery and hypertensive emergencies [1][2] Group 1: Product Approval and Market Potential - The consistency evaluation application for Nicardipine Hydrochloride Injection has been approved, indicating its readiness for clinical use in critical situations [1] - The sales scale of Nicardipine Hydrochloride Injection in Chinese public medical institutions is expected to exceed 600 million RMB in 2024, with a double-digit growth rate projected from 2022 to 2024, showing year-on-year increases of 35.71%, 16.09%, and 14.14% respectively [1] - The product is recognized as a first-line treatment in various hypertension management guidelines, including the 2020 International Society of Hypertension's Global Hypertension Practice Guidelines and the Chinese Hypertension Emergency Diagnosis and Treatment Guidelines [1] Group 2: Product Features and Competitive Advantage - Nicardipine Hydrochloride Injection is characterized by rapid onset, stable blood pressure reduction, and comprehensive organ protection, with non-toxic metabolites and enhanced safety [2] - The company offers a complete range of specifications for Nicardipine Hydrochloride Injection, including 5ml:5mg, 2ml:2mg, and 10ml:10mg, catering to diverse patient needs [2] - The quality and efficacy of Fosen Pharmaceutical's Nicardipine Hydrochloride Injection are consistent with reference formulations, allowing it to serve as a substitute for the original drug in clinical settings [2]