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兆科眼科-B:国家药监局批准PAN-90806的新药临床试验申请及盐酸依匹斯汀滴眼液取得国家药监局的上市批准
Zhi Tong Cai Jing· 2025-11-24 09:54
Core Viewpoint - The company has received regulatory approvals for two eye drop products, PAN-90806 for wet age-related macular degeneration (wAMD) and epinastine hydrochloride for allergic conjunctivitis, indicating significant advancements in its product pipeline and potential market impact [1][2]. Group 1: PAN-90806 Development - The National Medical Products Administration (NMPA) approved the clinical trial application for PAN-90806 on November 18, 2025, aimed at treating wAMD [1]. - PAN-90806 is a novel anti-VEGF eye drop formulation that offers a less invasive treatment option, potentially reducing the frequency of intravitreal injections associated with mainstream therapies [1]. - The anticipated benefits of PAN-90806 include improved patient comfort, adherence, and convenience, which may help slow disease progression and reduce treatment interruptions [1]. Group 2: Market Potential for wAMD - wAMD is a leading cause of vision loss and blindness among individuals over 50 in China and globally [1]. - The market for wAMD drugs in China is projected to grow from $241.5 million in 2019 to approximately $3.5 billion by 2030, with a compound annual growth rate (CAGR) of 27.5% [1]. Group 3: Epinastine Hydrochloride Approval - The company announced the NMPA approval for epinastine hydrochloride eye drops for allergic conjunctivitis on November 19, 2025 [1]. - Epinastine hydrochloride acts as a dual mechanism treatment, providing antihistamine effects and stabilizing mast cells, making it a first-line therapy for allergic conjunctivitis in China [2].
兆科眼科-B(06622):国家药监局批准PAN-90806的新药临床试验申请及盐酸依匹斯汀滴眼液取得国家药监局的上市批准
智通财经网· 2025-11-24 09:03
Core Insights - The company Zhaoke Ophthalmology-B (06622) has received approval from the National Medical Products Administration (NMPA) for clinical trials of PAN-90806 eye drops for the treatment of wet age-related macular degeneration (wAMD) [1] - The company also announced the approval of its eye drops, Epiphenidine Hydrochloride, for the treatment of allergic conjunctivitis [2] Group 1: PAN-90806 Eye Drops - PAN-90806 is a novel anti-VEGF eye drop formulation designed for wAMD treatment, characterized by favorable physicochemical properties and intended for external use [1] - If approved as a maintenance therapy, PAN-90806 is expected to provide significant convenience and less invasive treatment options for patients, reducing the frequency of intravitreal injections associated with mainstream anti-VEGF therapies [1] - The anticipated use of PAN-90806 is projected to significantly decrease treatment interruptions, enhancing patient comfort, acceptance, convenience, and adherence to medical advice, thereby slowing disease progression [1] Group 2: Market Potential - wAMD is a leading cause of vision loss and blindness among individuals over 50 years old in China and globally [1] - According to Frost & Sullivan, the market size for wAMD drugs in China is expected to grow from USD 241.5 million in 2019 to approximately USD 3.5 billion by 2030, with a compound annual growth rate (CAGR) of 27.5% [1] Group 3: Epiphenidine Hydrochloride - Epiphenidine Hydrochloride is an antihistamine eye drop with dual mechanisms of action, effective for treating allergic conjunctivitis, particularly in acute patients, and is considered a first-line therapy in China [2] - The company's Epiphenidine Hydrochloride is a generic version of Elestat, developed by Allergan [2]
兆科眼科(06622) - 自愿性公告-国家药监局批准PAN-90806的新药临床试验申请及盐酸依匹...
2025-11-24 08:57
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倚賴該等內容而引致的任何損失承擔任何責 任。 Zhaoke Ophthalmology Limited (於英屬處女群島註冊成立並於開曼群島存續的有限公司) 兆科眼科有限公司 (股份代號:6622) 自 願 性 公 告- 關 於PAN-90806 PAN-90806,一 種 用 於 治 療wAMD的 抗VEGF藥 物,為 一 種 新 型 滴 眼 液 配 方,屬 於 小 分 子 複 合 物,具 有 良 好 的 物 理 化 學 特 性,可 供 外 用。PAN-90806如獲批准作為 維 持 療 法,將 為 患 者 帶 來 極 大 便 利 性 及 較 小 侵 入 性 的 治 療 選 擇,降 低 主 流 抗 VEGF療 法 中 的 玻 璃 體 腔 內 注 射 頻 率 及 其 他 相 關 治 療 負 擔,同 時 維 持 視 力 穩 定 性。預 期 使 用PAN-90806將 大 幅 減 少 治 療 中 ...
康哲药业(00867) - 自愿性及业务进展公告 签订眼科药物诺适得与倍优适经销协议
2025-10-27 09:12
自願性及業務進展公告 簽訂眼科藥物諾適得®與倍優適®經銷協議 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本集 團」)欣然宣佈,於二零二五年十月二十七日,本集團通過本公司附屬公司與 Novartis Pharma Services AG (「諾華」)就雷珠單抗注射液(商品名:諾適得)(「諾 適得®」)、布西珠單抗注射液(商品名:倍優適)(「倍優適®」)簽訂經銷協議(「協議」)。 根據協議,本集團獲得產品在中華人民共和國(為協議之目的,不含香港特別行政區、 澳門特別行政區、台灣)(「區域」)的協議所約定之獨家進口、經銷、銷售、推廣權利; 諾華继续负责生產、供應產品。合作期限為协议约定的生效日起五年。 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,並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 諾適得® 諾適得®是重組抗血管內皮生長因子(VEGF)人源化單克隆抗體Fab片段,靶向抑制人血 管內皮生長因子A(VEGF-A),以抑制血管內皮細胞 ...