奥洛他定莫米松鼻喷雾剂
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港股公告掘金 | 中金公司拟换股吸收合并东兴证券及信达证券
Zhi Tong Cai Jing· 2025-12-17 15:17
Major Events - CICC (03908) plans a stock swap to absorb Dongxing Securities (601198.SH) and Xinda Securities (601059.SH), with resumption of trading on December 18 [1] - Yuanda Pharmaceutical (00512) has received approval to conduct clinical research in the U.S. for its self-developed innovative radiopharmaceutical GPN01530 [1] - Changfeng Pharmaceutical (02652) has had its clinical trial application for Olopatadine Mometasone nasal spray accepted by NMPA [1] - CRRC (01766) and its subsidiaries have signed significant contracts totaling approximately 53.31 billion yuan over the past three months [1] - Guangzhou Pharmaceutical, a subsidiary of Baiyunshan (00874), plans to invest around 500 million yuan to acquire 100% equity of Zhejiang Pharmaceutical Industry Co., Ltd. [1] Buybacks - China Metallurgical Group (01618) intends to repurchase up to 2 billion yuan of A-shares and 500 million yuan of H-shares [1] - Tencent Holdings (00700) repurchased 1.057 million shares for 636 million HKD on December 17 [1] - Techtronic Industries (00669) repurchased 500,000 shares for 44.91 million HKD on December 17 [1] - Country Garden Services (06098) repurchased 3.697 million shares for 23.17 million HKD on December 17 [1] - COSCO Shipping Holdings (01919) repurchased 285,750 shares for 38.61 million HKD on December 17 [1]
长风药业:奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA受理
Zhi Tong Cai Jing· 2025-12-17 12:52
Core Viewpoint - The company has received a notice of acceptance from the National Medical Products Administration (NMPA) for its clinical trial application of the fixed combination nasal spray, Olopatadine Mometasone, marking a significant step in its clinical development process [1][2] Group 1: Product Development - The product is a self-developed fixed combination nasal spray aimed at treating moderate to severe allergic rhinitis in specific age groups [1] - The formulation combines an antihistamine (Olopatadine) for allergy symptoms and a corticosteroid (Mometasone) for inflammation-related symptoms, potentially offering a convenient treatment option for patients who do not respond well to single therapies [1][2] - The fixed combination formulation is designed to reduce the need for patients to use multiple products, thereby enhancing medication convenience and adherence [1] Group 2: Strategic Importance - Advancing this product is deemed significant for expanding the company's nasal care product portfolio, potentially providing broader treatment options for moderate to severe patients upon approval [2] - The project highlights the company's R&D capabilities in nasal suspension formulations and drug-device integration, which typically have higher technical barriers and quality requirements compared to standard formulations [2] - Once approved, the product could complement the existing respiratory and nasal product lineup, strengthening market coverage in the airway disease treatment sector [2]
长风药业(02652):奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA受理
智通财经网· 2025-12-17 12:52
Core Viewpoint - The company has received a notice of acceptance from the National Medical Products Administration (NMPA) for its clinical trial application of the self-developed fixed combination nasal spray, Olopatadine Mometasone, marking the start of regulatory review for potential clinical development [1][2] Group 1: Product Development - The product is a fixed combination nasal spray designed to treat moderate to severe allergic rhinitis in specific age groups, combining an antihistamine and a corticosteroid in a single formulation [1] - The clinical research aims to evaluate whether this fixed combination can provide a convenient treatment option for patients whose symptoms are not effectively controlled by monotherapy [1] Group 2: Strategic Importance - Advancing this product is significant for the company as it will expand the allergy and rhinitis product line, offering broader treatment options for moderate to severe patients, depending on the approved label [2] - The project highlights the company's R&D capabilities in nasal suspension formulations and drug-device integration, which typically have higher technical barriers and quality requirements compared to standard formulations [2] Group 3: Market Positioning - Once approved, the product is expected to complement the existing respiratory and nasal product portfolio, enhancing market coverage in the field of airway disease treatment [2] - The company will maintain communication and cooperation with NMPA during the review process and comply with relevant laws and regulations [2]
长风药业(02652.HK):奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA受理
Ge Long Hui· 2025-12-17 12:50
Core Viewpoint - Changfeng Pharmaceutical (02652.HK) has received a notice of acceptance from the National Medical Products Administration (NMPA) for its clinical trial application of the self-developed fixed combination formulation, Olopatadine Mometasone nasal spray, marking a significant step in its clinical development process [1] Group 1: Product Information - Product Name: Olopatadine Mometasone nasal spray [1] - Application Type: Domestic production drug registration clinical trial [1] - Indication: Treatment of moderate to severe allergic rhinitis symptoms in adults and adolescents aged 12 and above [1] Group 2: Clinical Development - The acceptance of the clinical trial application signifies the product's entry into the regulatory review phase for potential clinical development by NMPA [1] - The clinical research aims to evaluate whether this fixed combination formulation can provide a convenient treatment option for patients whose symptoms are not effectively controlled by single therapies [1] Group 3: Strategic Alignment - This milestone aligns with the company's strategy to establish a differentiated portfolio of respiratory and nasal products [1] - The company intends to leverage its formulation, device integration, and manufacturing capabilities in the field of nasal drug-device combination products [1]
长风药业(02652) - 自愿公告 奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA受理
2025-12-17 12:40
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。 CF PharmTech, Inc. 長風藥業股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 本公司董事(「董事」)會(「董事會」)欣然宣佈,本集團就本公司自主研發的固定 複方製劑奧洛他定莫米松鼻噴霧劑(「產品」)作出的臨床試驗申請,已獲中國國家 藥品監督管理局(「NMPA」)發出受理通知書(「受理通知書」)。茲公告相關資訊如 下: 申請的適應症 : 治療成人及12歲以上青少年中重度過敏性鼻炎症狀 1 (股份代號:2652) 自願公告 奧洛他定莫米松鼻噴霧劑臨床試驗申請獲NMPA受理 本公告乃由長風藥業股份有限公司(「本公司」,連同其附屬公司統稱「本集團」)自 願作出,以知會股東及潛在投資者有關本集團之最新研發進展。 緒言 主要摘要 產品為本集團自主研發的固定複方鼻噴霧劑。臨床試驗申請獲受理標誌著其正式 進入NMPA潛在臨床開發的監管審查階段。 產品名稱 : 奧洛他定莫米松鼻噴霧劑 申請類型 ...