LUYE PHARMA(02186)
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港股公告掘金 | 协鑫新能源拟发行1.865亿股认购股份 牵手 Pharos加速Web3与新能源产业的融合
Zhi Tong Cai Jing· 2026-01-08 15:28
Major Events - GCL-Poly Energy (00451) plans to issue 186.5 million subscription shares to partner with Pharos to accelerate the integration of Web3 and the renewable energy industry [1] - Hansoh Pharmaceutical (03692) receives drug registration certificate from the National Medical Products Administration for the fifth indication of Amelot (Ametinib Mesylate Tablets) [1] - Green Leaf Pharmaceutical (02186) has its application for the new indication of the innovative drug Ruoxinlin for the treatment of generalized anxiety disorder accepted in China [1] - Xianjian Technology (01302) receives formal registration approval from the National Medical Products Administration for the G-iliacTM Pro iliac artery covered stent system [1] - Meirui Health International (02327) plans to acquire 100% equity of Jiangsu Yide for 125 million yuan [1] - Century International (00959) joint venture signs a memorandum of understanding with WPT to jointly develop, operate, and commercialize mobile applications [1] Operating Performance - Fast Retailing (06288) reports first-quarter earnings with a net profit attributable to shareholders of 147.445 billion yen, an increase of 11.7% year-on-year [1] - Agile Group (01813) reports December pre-sale amount of 420 million yuan, a decrease of 56.7% year-on-year [1] - Baolong Real Estate (01238) projects total contract sales of approximately 7.272 billion yuan for 2025, a decrease of 43.13% year-on-year [1] - China General Nuclear Power (01816) expects total on-grid electricity of approximately 2,326.48 billion kilowatt-hours for 2025, an increase of 2.36% year-on-year [1] - Lingbao Gold (03330) issues a profit warning, expecting net profit for the 2025 fiscal year to be approximately 1.503 to 1.573 billion yuan, an increase of about 115% to 125% year-on-year [1]
绿叶制药:1类创新药若欣林 用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理
Zhi Tong Cai Jing· 2026-01-08 11:46
Core Viewpoint - Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration for the new indication application of its innovative drug Ruoxinlin, aimed at treating generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] Group 1: Drug Development and Clinical Research - Ruoxinlin is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) for generalized anxiety disorder in China, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a remission rate of approximately 50% [1] - The safety profile of Ruoxinlin is favorable, with low incidences of adverse effects such as drowsiness, insomnia, fatigue, and sexual dysfunction, most of which are mild to moderate and tend to improve over time [1] Group 2: Market Context and Demand - 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% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, show limited efficacy with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside significant side effects that affect patient compliance [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 treatment landscape [2] Group 3: Company Strategy and Product Portfolio - Green Leaf Pharmaceutical has established a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio addressing various conditions including schizophrenia, bipolar disorder, and Alzheimer's disease [4] - The company’s product lineup includes Ruoxinlin, which has served nearly 190,000 patients since its launch, and has been recognized as one of the fastest-growing antidepressants in China [3] - The company is actively developing next-generation innovative drugs, with several candidates in clinical stages targeting multiple mechanisms [4]
绿叶制药(02186):1类创新药若欣林用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理
智通财经网· 2026-01-08 11:12
Core Viewpoint - Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration 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] Group 1: Product Development and Clinical Research - Ruoxinlin® is expected to be the first SNDRI 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 an efficacy rate exceeding 80% and a remission rate of approximately 50% [1] - The safety profile of Ruoxinlin® is favorable, with low incidences of adverse reactions such as drowsiness and sexual dysfunction, and no significant impact on weight or glucose-lipid metabolism [1] Group 2: Market Context and Demand - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million affected individuals, and the lifetime prevalence of generalized anxiety disorder in adults is estimated at 4.1%-6.6% [2] - Current first-line treatments, SSRIs and SNRIs, have limited efficacy, with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside common adverse effects that affect patient compliance [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 treatment landscape [2] Group 3: Company Strategy and Product Portfolio - The central nervous system treatment area, including depression and anxiety, is a core strategic focus for the company, which has developed a differentiated product portfolio addressing various mental health conditions [4] - In addition to Ruoxinlin®, the company’s portfolio includes other approved products such as Erzofri® and Rykindo®, and it is actively developing next-generation innovative drugs targeting multiple mechanisms [4] - Ruoxinlin® has served nearly 190,000 patients since its launch, gaining recognition for its efficacy and safety, and is expected to further enhance accessibility with its new indication [3]
绿叶制药(02186):1类创新药若欣林®用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理
智通财经网· 2026-01-08 11:10
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]
绿叶制药(02186.HK):1类创新药若欣林®用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理
Ge Long Hui· 2026-01-08 11:06
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].
绿叶制药(02186) - 自愿性公告 1类创新药若欣林用於治疗广泛性焦虑障碍的新适应症中国上市申请...
2026-01-08 11:00
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 ...
绿叶制药(02186) - 截至二零二五年十二月三十一日止月份之股份发行人的证券变动月报表
2026-01-06 08:43
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 绿叶制药集团有限公司 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02186 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 10,000,000,000 | USD | | 0.02 | USD | | 200,000,000 | 本 ...
绿叶制药:夏莲获委任为提名委员会成员
Zhi Tong Cai Jing· 2025-12-31 13:12
Group 1 - The company Green Leaf Pharmaceutical (02186) announced the appointment of Ms. Xia Lian as a member of the company's nomination committee, effective from December 31, 2025 [1]
绿叶制药(02186.HK):夏莲获委任为提名委员会成员
Ge Long Hui· 2025-12-31 11:04
Core Viewpoint - Green Leaf Pharmaceutical (02186.HK) announced the appointment of independent non-executive director Xia Lian as a member of the company's nomination committee, effective from December 31, 2025 [1] Group 1 - The company has made a strategic move to enhance its governance structure by appointing Xia Lian to the nomination committee [1] - This appointment reflects the company's commitment to improving its board composition and oversight [1] - The effective date of the appointment is set for December 31, 2025, indicating a forward-looking approach in governance [1]
绿叶制药(02186) - 本公司董事会辖下提名委员会的职权范围
2025-12-31 11:01
綠葉製藥集團有限公司 – 1 – (於 百 慕 達 註 冊 成 立 的 有 限 公 司) (股 份 代 號:02186) 本公司董事會轄下 提名委員會的職權範圍 於 二 零 一 四 年 六 月 十 九 日 根 據 董 事 會 之 決 議 案 採 納, 自 二 零 一 四 年 七 月 九 日 生 效,並 於 二 零 一 八 年 十 二 月 二 十 八 日 及二零二五年十二月三十一日修訂 宗 旨 1. 提 名 委 員 會 旨 在 協 助、識 別、甄 選 及 推 薦 合 適 人 選 及 推 薦 擔 任 綠葉製藥集 團 有限公司(「本公司」,連 同 其 附 屬 公 司 統 稱 為「本集團」)董事及就此向本 公司董事會(「董事會」)提 供 建 議,並 制 定 同 時 監 督 本 公 司 之 提 名 指 引。 組 成 會 議 2. 提 名 委 員 會 須 不 時 由 董 事 會 委 任,並 須 至 少 由 三(3)位 成 員 組 成,大 部 分 成 員 須 為 獨 立 非 執 行 董 事,每 位 成 員 均 須 符 合 香 港 聯 合 交 易 所 有 限 公 司 證 券上市規則(「上市規則」)不 時 規 定 之 獨 立 ...