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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.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]