Core Viewpoint - The successful completion of the Phase II clinical trial for GPN01360, an innovative traditional Chinese medicine for treating depression, marks a significant milestone for the company in the field of otolaryngology [1][2]. Group 1: Clinical Trial Results - The Phase II clinical trial involved 148 patients and demonstrated significant efficacy of GPN01360 compared to placebo, with a p-value of 0.0006 for the primary endpoint, the change in HAMD-17 score [2]. - Secondary efficacy indicators, including MADRS and HAMA, also showed significant differences compared to placebo (P<0.05) [2]. - GPN01360 exhibited good safety and tolerability, with no significant adverse effects reported during the trial [2]. Group 2: Product Information - GPN01360 is classified as a Class 1 innovative traditional Chinese medicine, based on the classic formula "Xiaoyao San," and consists of 12 herbal ingredients [2]. - The drug targets liver qi stagnation and spleen deficiency type depression, addressing symptoms such as low mood, cognitive slowing, anxiety, and insomnia [2]. Group 3: Market Context - Depression is a prevalent mental disorder affecting approximately 332 million people globally, with a prevalence rate of about 4.0%, and a higher rate of 6.8% in China [3]. - The clinical cure rate for depression remains below 30%, indicating a significant unmet clinical need for effective treatments [3]. Group 4: Company Strategy - The company is a leading player in the research, production, and sales of otolaryngology drugs, with a diverse product pipeline covering various therapeutic areas [4]. - The company is focusing on traditional Chinese medicine as a key strategic direction, expanding its offerings beyond otolaryngology to include cardiovascular and neurological diseases [4]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline [5].

Core Viewpoint - The announcement by Yuan Da Pharmaceutical (0512.HK) indicates a significant advancement in the development of domestic antidepressant drugs, with their innovative traditional Chinese medicine GPN01360 successfully reaching clinical endpoints in Phase II trials, showing notable efficacy and safety advantages for treating depression in China [1] Group 1 - The Phase II clinical study of GPN01360 has successfully achieved its clinical endpoints [1] - The product demonstrates significant efficacy and safety advantages [1] - GPN01360 is expected to become a new treatment option for depression patients in China [1] Group 2 - This development represents a major progress in the research and development of domestic antidepressant medications [1] - The success of GPN01360 contributes to the global treatment landscape for depression, showcasing China's capabilities in this field [1]

Core Viewpoint - The development of the domestic antidepressant drug GPN01360 by Yuan Da Pharmaceutical has achieved significant progress, marking a major milestone in the modernization of traditional Chinese medicine and offering a new treatment option for depression patients in China [1][2][8]. Group 1: Product Development and Clinical Trials - GPN01360 has successfully reached clinical endpoints in its Phase II clinical trial, demonstrating significant efficacy and safety advantages compared to placebo, with notable improvements in the Hamilton Depression Rating Scale (HAMD-17) scores [7][8]. - The drug is based on the ancient formula "Xiao Yao San," which has been validated through extensive clinical practice over the past century, and modern research indicates its potential antidepressant effects through mechanisms such as gut microbiome regulation [7][8]. Group 2: Market Potential and Demand - Depression is a prevalent mental health issue affecting approximately 332 million people globally, with a high recurrence rate of 75%-90%, leading to significant economic losses estimated at nearly $1 trillion annually [2][6]. - In China, the prevalence of depression among adults is 6.8%, higher than the global average, with around 95 million patients, indicating a growing demand for effective treatment options [2][6]. Group 3: Industry Trends and Policy Support - The Chinese antidepressant market is projected to grow from approximately 9.7 billion yuan in 2024 to 14.3 billion yuan by 2029, at a compound annual growth rate (CAGR) of 8.1% [2]. - Recent government policies have encouraged innovation in traditional Chinese medicine, enhancing the approval efficiency for new drugs and supporting the transformation of traditional formulas into modern medications [9][13]. Group 4: Strategic Positioning of Yuan Da Pharmaceutical - Yuan Da Pharmaceutical is positioned as a leading enterprise in the research, production, and sales of otorhinolaryngology drugs, with a diverse product pipeline covering various therapeutic areas, including traditional Chinese medicine [10][13]. - The company aims to leverage its strengths in traditional Chinese medicine to expand into chronic disease management, particularly in cardiology and neurology, thereby broadening its market reach and enhancing its competitive edge [9][13].

Core Viewpoint - The successful completion of the Phase II clinical trial for GPN01360, an innovative traditional Chinese medicine for treating depression, marks a significant milestone for the company in the field of otolaryngology [1][2]. Group 1: Clinical Trial Results - The Phase II clinical trial involved 148 patients and demonstrated significant efficacy of GPN01360 compared to placebo, with a p-value of 0.0006 for the primary endpoint, the change in HAMD-17 score [2]. - Secondary efficacy indicators, including MADRS and HAMA, also showed significant differences compared to placebo (P<0.05) [2]. - GPN01360 exhibited good safety and tolerability, with no significant adverse effects reported during the trial [2]. Group 2: Product and Market Context - GPN01360 is classified as a Class 1 innovative traditional Chinese medicine, based on the classic formula "Xiaoyao San," and consists of 12 herbal ingredients aimed at alleviating symptoms of liver qi stagnation and spleen deficiency [2]. - Depression is a major global public health issue, affecting approximately 332 million people worldwide, with a prevalence rate of about 4.0%, and a higher rate of 6.8% in China [3]. - The clinical cure rate for depression remains below 30%, indicating a significant unmet clinical need, which GPN01360 aims to address [3]. Group 3: Company Strategy and Positioning - The company is a leading player in the research, production, and sales of otolaryngology drugs in China, with a diverse product pipeline covering various therapeutic areas [4]. - The company is focusing on traditional Chinese medicine as a key strategic direction, expanding its offerings beyond otolaryngology to include cardiovascular and neurological diseases [4]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline through a global operational strategy [5].

Core Viewpoint - The successful completion of the Phase II clinical trial for GPN01360, an innovative traditional Chinese medicine for treating depression, marks a significant milestone for the company in the otolaryngology sector [1][2]. Group 1: Clinical Trial Details - The Phase II clinical trial was a randomized, double-blind, placebo-controlled, multi-center study involving 148 patients with depression, focusing on the efficacy and safety of GPN01360 over an 8-week oral administration period [1]. - The primary endpoint was the change in the Hamilton Depression Rating Scale (HAMD-17) score from baseline, with secondary endpoints including the Montgomery-Åsberg Depression Rating Scale (MADRS), HAMD-17 remission and response rates, Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Improvement (CGI-I) scores [1]. Group 2: Efficacy and Safety Results - Results indicated a significant difference in the primary efficacy endpoint (HAMD-17) compared to placebo (P=0.0006 < 0.05), with secondary efficacy endpoints also showing significant differences (P < 0.05) [2]. - GPN01360 demonstrated good safety and tolerability, with no significant adverse effects reported during the trial, suggesting its potential for treating depression, anxiety, and insomnia symptoms [2]. Group 3: Product Background - GPN01360 is classified as a Class 1 innovative traditional Chinese medicine, derived from the classical formula "Xiaoyao San," optimized through modern pharmacology and clinical research, consisting of 12 herbal ingredients [2]. - The medicine targets liver qi stagnation and spleen deficiency type depression, with typical symptoms including low mood, slow thinking, reduced willpower, anxiety, insomnia, poor appetite, and fatigue [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 本集團中藥 1 類創新藥 GPN01360 在中國開展的 II 期臨床研究成功達到臨床終點 -1- 0.05）；PSQI 展現出明顯的治療趨勢。此外，GPN01360 安全性和耐受性較好，在整個 試驗期間未發現明顯的毒副作用。以上研究結果表明，GPN01360 在抑鬱症的治療方面 有較好的安全性和有效性，且對抑鬱伴焦慮、失眠等症狀的改善也較為明顯。 GPN01360 是一款用於治療抑鬱症（肝鬱脾虛證）的 1.1 類中藥創新藥，基於古代經典 方劑「逍遙散」，通過現代藥理學與臨床研究篩選優化而成，處方由柴胡、郁金、佛手 等 12 味中藥組成，具有疏肝健脾、解鬱安神的功效。該中藥主要用於治療肝鬱脾虛型 抑鬱症，其典型症狀包括情緒低落、思維遲緩、意 ...

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) 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。 自願性公告 關於 2021 年及 2022 年年報之補充公告 茲提述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」）分別於 2022 年 4 月 25 日及 2023 年 4 月 27 日刊發之 2021 年年報及 2022 年年報（「年報」）。 除另有定義外，本函件所用之詞彙與年報所界定者具有相同涵義。 | | | | 退休福利 | | | --- | --- | --- | --- | --- | | | 袍金 | 薪金及津貼 | 計劃供款 | 合計 | | | 港幣千元 | 港幣千元 | 港幣千元 | 港幣千元 | | 執行董事： | | | | | | 劉程煒先生（於二零二一年六 | | | | | | 月一日退任） | 21 ...

国内干眼药物治疗领域正在加速变革。 干眼新机制药物初露头角 长期以来，传统干眼药物多聚焦于缓解症状，以玻璃酸钠滴眼液为代表的人工泪液是主流产品。在医药电商平台的干眼用药销售排行榜上，前十位产品绝 大多数为玻璃酸钠滴眼液。 在国内眼科市场，一批已上市干眼新药开始崭露头角，填补传统治疗的空白。 这些新机制药物凭借从源头解决干眼问题的临床价值，已初步获得市场认可，一组销售数据可以佐证。 2025年，恒瑞医药用于干眼的"恒沁"全氟己基辛烷滴眼液上市，电商平台零售价468元/盒，在京东大药房上线3个多月（1盒装）销量达到5000+，并跻 身"眼干涩"用药排行榜第8。2024年底，远大医药引进的酒石酸伐尼克兰鼻喷雾剂在国内获批上市，零售价599元/支，2025年上半年成为远大医药五官科 收入增长的动力之一。 与传统干眼药物相比，这些基于新机制的干眼药物价格高出几倍甚至十倍，仍实现了上市即热销。这是否意味着，干眼药物市场的竞争逻辑与发展格局或 将发生变革？ 睑板腺功能障碍（MGD）是睑板腺的慢性、非特异性炎症，以睑板腺导管的阻塞或睑板腺分泌物异常为特征，是蒸发过强型干眼的主要原因。有临床研 究显示，69%—86%的干眼人群 ...

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11月30日 狀態: 新提交 致：香港交易及結算所有限公司 第 1 頁 共 10 頁 v 1.1.1 FF301 FF301 II. 已發行股份及/或庫存股份變動 公司名稱: 遠大醫藥集團有限公司 呈交日期: 2025年12月1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) | 00512 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 100,000,000,000 | HKD | | 0.01 | HKD | | 1,000,000,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 100 ...

Investment Rating - The industry investment rating is "Outperform the Market" [1][31]. Core Viewpoints - The report highlights the initiation of centralized procurement for electrophysiology and neuro-interventional medical consumables in Beijing, which is expected to promote the entry of domestic high-end products and accelerate domestic substitution [4]. - The procurement covers all public medical institutions in Beijing, with a two-year agreement period, and includes various categories of electrophysiology and neuro-interventional products [4]. - The report suggests focusing on leading companies with comprehensive layouts in the electrophysiology field, such as Huatai Medical and Microelectrophysiology [4]. Summary by Sections Industry Overview - The centralized procurement for electrophysiology and neuro-interventional consumables has officially started, with a deadline for submission set for December 1 [4]. - The procurement is led by six top-tier hospitals in Beijing and aims to enhance the availability of domestic products [4]. Investment Strategy - The report recommends attention to innovative drug companies with rich pipeline layouts, such as Heng Rui Medicine, BeiGene, and China Biopharmaceuticals [6]. - It also highlights companies with significant single-product potential and those leading in advanced technology platforms [6]. Market Performance - The pharmaceutical sector saw a 2.67% increase last week, outperforming the CSI 300 index, which rose by 1.64% [9][20]. - In the Hong Kong market, the pharmaceutical sector increased by 3.85%, leading among 11 sectors [30]. Notable Industry News - Abbott announced a $21 billion acquisition of Exact Sciences, enhancing its position in the cancer diagnostics field [13]. - Johnson & Johnson is acquiring Halda Therapeutics for $3.05 billion, focusing on prostate cancer treatments [14]. - A significant ophthalmic drug has been approved for market release, expanding treatment options for age-related macular degeneration [16]. - Novartis received approval for its oral drug Remibrutinib in China, targeting chronic spontaneous urticaria [17].