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长风药业:NMPA受理布地奈德鼻喷雾剂上市许可申请
Zhi Tong Cai Jing· 2026-01-29 22:50
Core Viewpoint - Changfeng Pharmaceutical (02652) has received acceptance for its application for the marketing authorization of Budesonide nasal spray from the National Medical Products Administration of the People's Republic of China [1] Product Pipeline - The nasal spray is a complex formulation with high technical barriers, and the company has established a comprehensive product matrix covering various indications and full-course management of respiratory and rhinitis conditions [1] - Existing products in the company's portfolio include: - Fluticasone furoate nasal spray (Shu Fei Min): The first antihistamine-steroid combination nasal spray in China, included in the National Medical Insurance Drug List in 2023 [1] - Mometasone furoate nasal spray: A first-line medication for allergic rhinitis in adults and children aged 3 and above [1] - Budesonide nasal spray (the product in question): Suitable for patients aged 6 and above, targeting seasonal acute episodes, perennial maintenance treatment, and nasal polyps [1] - Olopatadine/Mometasone nasal spray: For moderate to severe allergic rhinitis symptoms in adolescents aged 12 and above and adults [1] Strategic Intent - The acceptance of the Budesonide nasal spray application further enriches the company's product pipeline in the allergic rhinitis field, demonstrating the company's commitment and capability to deepen its layout in the respiratory inhalation treatment sector, providing quality treatment options for patients [1] - The company will actively communicate with the NMPA and advance subsequent review procedures according to regulatory requirements [1]
长风药业(02652):NMPA受理布地奈德鼻喷雾剂上市许可申请
智通财经网· 2026-01-29 22:49
Core Viewpoint - Changfeng Pharmaceutical's application for the marketing authorization of Budesonide nasal spray has been accepted by the National Medical Products Administration of China, indicating the company's commitment to expanding its product pipeline in the field of allergic rhinitis and respiratory treatments [1] Product Pipeline - The company has established a comprehensive product matrix covering various indications and full-course management of respiratory and rhinitis conditions, leveraging its nasal drug delivery technology platform [1] - Existing products in the company's portfolio include: - Azelastine/Fluticasone nasal spray (Shu Fei Min®): The first antihistamine-steroid combination nasal spray in China, included in the National Medical Insurance Drug List in 2023 [1] - Mometasone nasal spray: A first-line medication for allergic rhinitis in adults and children aged 3 and above [1] - Budesonide nasal spray: Targeted for patients aged 6 and above, addressing seasonal acute episodes, perennial maintenance treatment, and nasal polyps [1] - Olopatadine/Mometasone nasal spray: Designed for adolescents aged 12 and above and adults with moderate to severe allergic rhinitis symptoms [1] Strategic Commitment - The acceptance of the Budesonide nasal spray application further enriches the company's product pipeline in the allergic rhinitis sector, demonstrating its determination and capability to deepen its presence in the respiratory inhalation treatment field [1] - The company will actively communicate with the NMPA and advance subsequent review procedures in accordance with regulatory requirements [1]
长风药业(02652) - 自愿公告NMPA受理布地奈德鼻喷雾剂上市许可申请
2026-01-29 22:06
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) (股份代號:2652) 自願公告 NMPA受理布地奈德鼻噴霧劑上市許可申請 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 本公司董事(「董事」)會(「董事會」)欣然宣佈,本公司布地奈德鼻噴霧劑(「該 產品」)的上市許可申請(「申請」)已獲中華人民共和國國家藥品監督管理局 (「NMPA」)受理。茲公告相關資訊如下: 1 產品名稱 : 布地奈德鼻噴霧劑 申請類型 : 上市許可申請 受理號 : CYHS2600272/CYHS2600273 申請人 : 本公司 規格 : 每噴32微克(每瓶120噴)╱每噴64微克(每瓶 120噴) 適應症 : 治療(1)季節性及常年性過敏性鼻炎;(2)常年性 非過敏性鼻炎;及(3 ...