Group 1 - The core point of the news is that Green Leaf Pharmaceutical (02186.HK) has completed patient enrollment for its Phase III clinical trial of the innovative drug Ruoxinlin® (Toralacitinib) for treating Generalized Anxiety Disorder (GAD) [1] - The Phase III trial is a multi-center, randomized, double-blind, placebo-controlled study involving 555 patients, with the primary endpoint being the change in Hamilton Anxiety Scale (HAM-A) scores from baseline at week 8 [1] - The company expects to complete the clinical trial by the end of this year and submit a marketing application for this indication [1] Group 2 - Generalized Anxiety Disorder is the most common mental disorder in China, affecting approximately 53.1 million people as of 2021, with a long duration and high recurrence rate impacting patients' quality of life [1] - Ruoxinlin® is expected to be the first drug globally approved for treating GAD that acts as a triple reuptake inhibitor of serotonin (5-HT), norepinephrine (NE), and dopamine (DA) [1] - Current first-line treatments for GAD include SSRIs and SNRIs, which have common side effects leading to low patient compliance and treatment discontinuation [2] Group 3 - Ruoxinlin® is the first domestically developed innovative drug for treating depression in China, having been approved for market since 2022, and has shown efficacy and safety in clinical settings [2] - Clinical trials have demonstrated that Ruoxinlin® significantly improves depression symptoms without causing insomnia, sedation, or affecting sexual function, weight, and lipid metabolism [2] - The drug also shows potential anxiolytic effects, improving HAM-A scores and other anxiety-related measures while providing antidepressant benefits [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 的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。 LUYE PHARMA GROUP LTD. 綠葉製藥集團有限公司 （於 百 慕 達 註 冊 成 立 之 有 限 公 司） （股 份 代 號：02186） 自願性公告 若欣林®治療廣泛性焦慮障礙的 中國Ⅲ期臨床試驗完成所有患者入組 綠葉製藥集團 有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）董事會（「董 事 會」）宣 佈，本 集 團 自 主 研 發 的1類創新藥若欣林® （鹽 酸 托 魯 地 文 拉 法 辛 緩 釋 片）用 於 治 療 廣 泛 性 焦 慮 障 礙 的 Ⅲ 期 臨 床 試 驗 已 完 成 所 有 患 者 入 組。 該 項 Ⅲ 期 臨 床 試 驗 為 一 項 多 中 心、隨 機、雙 盲、安 慰 劑 對 照 的 研 究，以 評 估 若 欣 林®治 療 廣 泛 性 焦 慮 障 礙 的 安 全 性 和 有 效 性。試 ...