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兆科眼科-B(06622.HK):就于台湾地区商业化BRIMOCHOL™ PF与东生华制药订立策略性伙伴关系
Ge Long Hui· 2025-12-08 09:10
Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622.HK), has established a strategic partnership with Taiwan-based Dongshenghua Pharmaceutical Co., Ltd. to jointly advance the clinical introduction and future commercialization of BRIMOCHOL™ PF in Taiwan [1] Group 1: Partnership Details - Zhaoke grants Dongshenghua exclusive rights as a distributor in Taiwan for the registration, importation, promotion, distribution, marketing, and sale of BRIMOCHOL™ PF [1] - Dongshenghua specializes in chronic diseases and precision medicine, providing safe and accessible healthcare solutions [1] Group 2: Regulatory Updates - In June 2025, Tenpoint Therapeutics, the developer of BRIMOCHOL™ PF, announced that the U.S. FDA has accepted the new drug application for the product [1] - The FDA has set a review deadline for the Prescription Drug User Fee Act (PDUFA) for BRIMOCHOL™ PF on January 28, 2026 [1]
国产替代加速!兆科眼科依匹斯汀滴眼液入局,重塑过敏性结膜炎用药市场格局
Ge Long Hui· 2025-11-26 13:19
Core Insights - The approval of the eye drop product, Hydrochloride Epiphrine Eye Drops, by Zhaoke (Guangzhou) Ophthalmic Pharmaceuticals marks a significant milestone as it becomes the second company in China to receive approval for this generic drug, which is primarily used to treat allergic conjunctivitis [1][5][8] - The market for allergic conjunctivitis treatments in China is substantial, with total sales projected to exceed 1.5 billion yuan in 2024, indicating a lucrative opportunity for the newly approved products [3][4] Company Developments - Zhaoke (Guangzhou) has successfully obtained approval for seven generic drugs, enhancing its competitive position in the ophthalmic market [1][5] - The company is actively expanding its product line, with several other ophthalmic products, including Atropine Sulfate Eye Drops and Bevacizumab Eye Injection, currently under review for approval [9][11] - The recent approval of PAN-90806, an innovative drug for treating wet age-related macular degeneration, further demonstrates Zhaoke's commitment to both generic and innovative drug development [11] Market Context - The approval of Hydrochloride Epiphrine Eye Drops follows the earlier approval of the same product by Guangzhou Runer Ophthalmology, indicating a competitive landscape in the ophthalmic drug market [5][8] - The lack of approved imported products for this specific drug in China, coupled with ongoing applications from original manufacturers, suggests a growing domestic market for these treatments [5][8] - The regulatory body's prioritization of Hydrochloride Epiphrine Eye Drops for pediatric use highlights the potential for broader market acceptance and patient accessibility [8]
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.HK):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
Ge Long Hui· 2025-11-24 09:05
Core Viewpoint - The company Zhaoke Ophthalmology-B (06622.HK) has received regulatory approvals for two significant ophthalmic treatments, indicating a positive development in its product pipeline and potential market impact [1] Group 1: Regulatory Approvals - On November 18, 2025, the National Medical Products Administration of China approved the company's clinical trial application for PAN-90806 eye drops aimed at treating wet age-related macular degeneration (wAMD) [1] - On November 19, 2025, the company announced that it received market approval for the antihistamine eye drops, Epiphenidine Hydrochloride, for the treatment of allergic conjunctivitis [1] Group 2: Product Details - PAN-90806 is a novel anti-VEGF eye drop formulation characterized as a small molecule compound with favorable physicochemical properties 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 use of PAN-90806 is anticipated to greatly decrease treatment interruptions, enhancing patient comfort, acceptance, convenience, and adherence to medical advice, thereby slowing disease progression [1] Group 3: Competitive Landscape - Epiphenidine Hydrochloride is positioned as a first-line therapy for allergic conjunctivitis in China, particularly for acute patients, and is a generic version of Elestat developed by Allergan [1]
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 ...