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联邦制药(03933.HK):注射用UBT37034超重或肥胖适应症获临床试验默示许可
Ge Long Hui· 2025-09-30 08:57
Core Viewpoint - The announcement highlights the approval of a clinical trial application for UBT37034, a novel peptide receptor agonist targeting overweight or obesity, indicating a significant advancement in the company's product pipeline and potential market competitiveness [1] Group 1: Clinical Trial Approval - The clinical trial registration application for UBT37034 received implied approval from the National Medical Products Administration of China, with acceptance number CXHL2500772 [1] - UBT37034 is designed to selectively act on the neuropeptide Y2 receptor to aid in weight reduction [1] Group 2: Preclinical and Regulatory Milestones - Preclinical studies in various animal models demonstrated that UBT37034, in combination with GLP-1 analogs, can significantly reduce body weight [1] - The Investigational New Drug (IND) application for UBT37034 was approved by the U.S. Food and Drug Administration on July 2025, with IND number 175188 [1] Group 3: Future Outlook - The company aims to continue its focus on new product development to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - There is an expectation that these advancements will generate greater returns for the company and its shareholders [1]
联邦制药(03933):注射用UBT37034超重或肥胖适应症获临床试验默示许可
Zhi Tong Cai Jing· 2025-09-30 08:52
Core Viewpoint - Federal Pharmaceutical (03933) has received implied approval for clinical trials of its injectable drug UBT37034 for overweight or obesity indications from the National Medical Products Administration of China [1] Group 1: Drug Development - UBT37034 is a novel peptide receptor agonist that selectively targets neuropeptide Y2 receptors to aid in weight loss [1] - Preclinical studies in various animal models indicate that UBT37034, when used in conjunction with GLP-1 analogs, significantly reduces body weight [1] - The new drug clinical trial application (IND) for UBT37034 regarding overweight or obesity indications was approved by the U.S. Food and Drug Administration on July 2025, with IND number 175188 [1] Group 2: Future Outlook - The company will continue to focus on new product development and aims to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - The anticipated advancements are expected to generate greater returns for the company and its shareholders [1]
联邦制药:注射用UBT37034超重或肥胖适应症获临床试验默示许可
Zhi Tong Cai Jing· 2025-09-30 08:41
Core Viewpoint - Federal Pharmaceutical (03933) announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., received implicit approval from the National Medical Products Administration of China for the clinical trial registration application of its innovative drug UBT37034 for overweight or obesity indications [1] Group 1: Product Development - UBT37034 is a novel peptide receptor agonist that selectively targets neuropeptide Y2 receptors to aid in weight reduction [1] - Preclinical studies in various animal models indicate that UBT37034, when used in conjunction with GLP-1 analogs, significantly reduces body weight [1] - The new drug clinical trial application (IND) for UBT37034 regarding overweight or obesity indications was approved by the U.S. Food and Drug Administration in July 2025, with IND number 175188 [1] Group 2: Future Outlook - The company will continue to focus on new product development and aims to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - The anticipated advancements in product development are expected to generate greater returns for the company and its shareholders [1]
联邦制药(03933) - 注射用UBT37034超重或肥胖适应症获临床试验默示许可
2025-09-30 08:32
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,概不對因本公告全部或任何部份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。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 本公告乃由聯邦制藥國際控股有限公司(「本公司」)自願發出。 本公司董事會欣然公佈,於二零二五年九月二十九日,本公司全資附屬公司聯邦生物科技 (珠海橫琴)有限公司自主研發的 1 類創新藥注射用 UBT37034 關於超重或肥胖適應症的 臨 床 試 驗 註 冊 申 請 獲 得 中 國 國 家 藥 品 監 督 管 理 局 臨 床 試 驗 默 示 許 可 , 受 理 號 為 CXHL2500772。 UBT37034 是一款新型多肽類受體激動劑,可通過選擇性作用於神經肽 Y2 受體減輕體重。 臨床前多種動物模型研究結果顯示,UBT37034 與 GLP-1 類似物聯用能夠顯著降低體重。 此外,UBT37034 注射液關於超重或肥胖適應症的新藥臨床試驗申請(「IND」)已於二零二 ...