Group 1 - The core point of the news is that Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration of China for the new indication application of its innovative drug, Ruoxinlin®, for the treatment of generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] - Ruoxinlin® is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) in China for treating generalized anxiety disorder, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating that Ruoxinlin® can rapidly and comprehensively improve anxiety symptoms, with an efficacy rate exceeding 80% and a relief rate of approximately 50% [1] Group 2 - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million people affected, and generalized anxiety disorder has a lifetime prevalence rate of about 4.1%-6.6% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, have limited efficacy, with a meta-analysis showing an overall efficacy rate of 67.7% and a relief rate of only 39.7% [2] - The market size for SSRIs and SNRIs is projected to be 4.83 billion yuan in 2024, with no innovative drugs approved in the last 20 years, highlighting a significant gap in the supply of innovative anti-anxiety treatments in China [2] Group 3 - Ruoxinlin® has served nearly 190,000 patients since its approval, gaining widespread recognition for its efficacy and safety, and is one of the fastest-growing antidepressants in China [3] - The drug is expected to be included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog by the end of 2024, further enhancing its accessibility [3] - The company has a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio that includes treatments for schizophrenia, bipolar disorder, and Alzheimer's disease, alongside ongoing development of next-generation innovative drugs [4]

Core Viewpoint - Green Leaf Pharmaceutical has officially submitted a new indication application for its innovative drug Ruxinlin® to treat generalized anxiety disorder, marking a significant milestone following its approval for depression treatment in November 2022 [1][3]. Group 1: Company Developments - Ruxinlin® is expected to be the first domestic drug to treat generalized anxiety disorder as a serotonin, norepinephrine, and dopamine reuptake inhibitor (SNDRI) [1]. - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a response rate of approximately 50% [1]. - Ruxinlin® has served nearly 190,000 patients since its launch, gaining recognition for its efficacy and safety, and is one of the fastest-growing antidepressants in China [3]. Group 2: Industry Context - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million affected individuals, and generalized anxiety disorder has a lifetime prevalence of about 4.1%-6.6% [2]. - Current first-line treatments for anxiety disorders, including SSRIs and SNRIs, show limited efficacy, with overall effectiveness rates of 67.7% and response rates of only 39.7% [2]. - The market for SSRIs and SNRIs is projected to reach 4.83 billion yuan in 2024, with no new innovative drugs approved in the last 20 years, highlighting a significant gap in the supply of innovative anxiety treatments [2].

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 1類創新藥若欣林®用於治療廣泛性焦慮障礙的 新適應症中國上市申請獲得受理 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。 臨 床 應 用 中，選 擇 性5－羥 色 胺 再 攝 取 抑 制 劑（「SSRIs」）、5－羥 色 胺 和 去 甲 腎 上 腺素再攝取抑制劑（「SNRIs」）被 廣 泛 用 於 焦 慮 譜 系 障 礙 的 治 療，也 是 目 前 治 療 廣 泛 性 焦 慮 障 礙 的 一 線 藥 物。然 而，該 兩 類 藥 物 的 療 效 仍 有 限。薈 萃 分 析 顯 示， SSRIs/SNRIs整體有效率為67.7%，緩 解 率 僅 為39.7%；此 外，該 兩 類 藥 物 通 常 伴 有 脂 代 謝 紊 亂、體 重 ...

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. ADP、PDP及NSS的 全 球 病 患 人 數 龐 大。具 體 而 言，阿 爾 茨 海 默 病 全 球 患 者 人 數 約4,500萬，其 中25%至50%會 在 疾 病 病 程 中 出 現 精 神 症 狀；帕 金 森 病 患 者 人 數 超 過850萬，其 中PDP的長期累積患病率約為60%；精 神 分 裂 症 患 者 人 數 約2,300 萬，具 有 陰 性 症 狀 的 比 例 約 為60%。 – 1 – 目 前，全 球 僅 有 一 款 藥 物 獲 得 美 國FDA批准用於治療PDP，該 藥 物 尚 未 在 中 國 獲 批；在 治 療ADP方 面，國 內 外 尚 無 藥 物 獲 批 上 市；在 治 療NSS方 面，僅 有 少 數 藥物對於NSS有 效 但 療 效 欠 佳；上 述 三 種 適 應 ...

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 ...