Core Viewpoint - The announcement by Yuan Da Pharmaceutical regarding the completion of the first patient enrollment in the IIa clinical trial for the innovative ophthalmic drug GPN00884 indicates a significant step towards evaluating its efficacy and safety in delaying myopia progression in children [1] Group 1: Clinical Trial Details - The IIa clinical trial is a randomized, double-blind, placebo-controlled study [1] - The trial aims to enroll over 80 participants aged 6 to 12 years with myopia [1] - The primary objective is to evaluate the effectiveness of GPN00884 eye drops in delaying the progression of myopia in children and to assess its safety profile [1]

Core Insights - The company Yongda Pharmaceutical (00512) has announced the completion of the first patient enrollment in the IIa clinical trial for its innovative ophthalmic drug GPN00884, aimed at delaying the progression of myopia in children [1][2] - GPN00884 is a novel eye drop formulation that does not cause pupil dilation or associated side effects, potentially improving patient compliance compared to existing treatments like low-concentration atropine [1] - The IIa trial will enroll over 80 participants aged 6 to 12 years to evaluate the efficacy and safety of GPN00884 in a randomized, double-blind, placebo-controlled setting [1] Group 1 - GPN00884 is designed to address the unmet clinical needs in the treatment of myopia in children, where there is currently a lack of effective and safe medications in the domestic market [1] - The drug has previously completed a successful I phase clinical trial, demonstrating good safety and tolerability in healthy subjects, with linear pharmacokinetic characteristics [2] - The initiation of the IIa clinical trial marks a significant milestone for the company in the ophthalmology sector [2]

Core Viewpoint - The company has initiated a Phase IIa clinical trial for its innovative ophthalmic drug GPN00884, aimed at slowing the progression of myopia in children, marking a significant milestone in its ophthalmology segment [1][2] Group 1: Clinical Trial Details - The Phase IIa clinical trial is a randomized, double-blind, placebo-controlled study that plans to enroll over 80 participants aged 6 to 12 years [1] - The primary objective is to evaluate the efficacy and safety of GPN00884 eye drops in delaying myopia progression in children [1] Group 2: Product Characteristics - GPN00884 eye drops feature a novel mechanism of action and do not cause pupil dilation, light sensitivity, or accommodation reduction, which enhances patient compliance [1] - There is currently a lack of effective and safe medications for delaying myopia progression in children in the domestic market, indicating an unmet clinical need [1] Group 3: Previous Research Milestones - GPN00884 eye drops were previously approved for Phase I clinical research in March 2024, with all participants enrolled by August of the same year [2] - The Phase I results demonstrated good safety and tolerability in healthy subjects, with linear pharmacokinetic characteristics [2]

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之內容概不負責，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 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 本集團全球創新眼科藥物 GPN00884 在中國開展的 IIa 期臨床研究完成了首例患者入組 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告，本集團用於延緩兒童近視進展的全球創新眼科藥物 GPN00884 在中國 開展的 IIa 期臨床研究，近日完成了首例患者入組。該研究是一項隨機、雙盲、安慰劑 平行對照的 IIa 期臨床試驗，擬入組 80 餘例 6~12 周歲近視受試者，旨在初步評價 GPN00884 滴眼液延緩兒童近視進展的有效性及在兒童近視患者中的安全性。 本集團始終以眼科領域作為重要戰略發展方向之一，持續聚焦眼科藥物創新，堅持專業 化發展道路，不斷提升行業地 ...