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 ...

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 ...

Group 1: Market Overview - Pluvicto has become a major topic in the nuclear medicine field, with sales projected to reach $1.392 billion in 2024, a 42% increase year-over-year [1] - The sales of Pluvicto for the first three quarters of this year reached $1.389 billion, reflecting a 33% year-over-year growth [1] - Novartis predicts that Pluvicto's peak sales will exceed $5 billion [1] Group 2: Competitive Landscape - Major pharmaceutical companies such as Eli Lilly, BMS, AstraZeneca, and Roche are actively entering the nuclear medicine market [2][5] - Domestic companies like Heng Rui and Chengdu Nuyret are also making significant strides in nuclear medicine research and development [2][6] - The market is experiencing a new wave of growth, particularly in radiolabeled drug conjugates (RDC) [2][5] Group 3: Clinical Developments - Novartis leads the nuclear medicine sector with multiple products, including Lutathera and Pluvicto, and is developing additional candidates like 177Lu-NeoB and 225Ac-PSMA-617 [5][6] - Several domestic companies have products in late-stage clinical trials, such as ITM-11 and NRT6003, targeting various cancers [6][11] - The clinical pipeline for 177Lu-based products is expanding, with 17 innovative drug products currently in clinical stages in China [9] Group 4: Supply Chain and Production - The supply chain for Lu-177 has seen significant improvements, with domestic production capabilities being established to meet market demand [13][14] - The launch of the core product Lu-177 by Hefu One on June 25, 2025, marks a major breakthrough in the domestic production of medical isotopes [13] - The integration of nuclear medicine production and supply chains is becoming more evident, particularly in regions like Sichuan and Haiyan [23] Group 5: Future Trends - Research is expanding into new alpha-emitting isotopes, with a focus on Ac-225, which has shown promise in treating various cancers [15][17] - The supply chain challenges for Ac-225 are more severe than those for Lu-177, with a significant gap between production and clinical demand [22] - The nuclear medicine sector is entering a new phase of rapid growth, driven by advancements in both research and production capabilities [24]

Core Insights - The ITP drug treatment market in China is projected to grow, reaching 2.4 billion yuan in 2024, an increase of 200 million yuan from 2023, and is expected to reach approximately 2.8 billion yuan in 2025 [1][3][4] - Eltrombopag, a novel oral small molecule TPO receptor agonist, has shown excellent efficacy in treating ITP, significantly expanding treatment options for patients [1][4][7] - The sales of Eltrombopag in hospitals reached 376 million yuan in 2023, with an estimated 430 million yuan for the entire year of 2024 [1][4] ITP Drug Treatment Industry Pathway - ITP, or Immune Thrombocytopenic Purpura, is primarily treated with corticosteroids as the first-line therapy, while second-line treatments include platelet-stimulating drugs [2][4] - The incidence of ITP in adults in China is estimated at 5 to 10 per 100,000, with a projected 130,400 patients in 2024 [2][3] ITP Drug Treatment Industry Development Status - The ITP drug treatment market has been expanding, with a notable increase in treatment options due to ongoing research into the disease's pathophysiology [4][6] - The market is characterized by a growing number of patients and an increasing demand for effective treatments [2][3] ITP Drug Treatment Industry Chain - The upstream of the ITP drug treatment industry includes active pharmaceutical ingredients (APIs), chemical raw materials, and related equipment, while the midstream focuses on drug manufacturing [4][6] ITP Drug Treatment Competitive Landscape - Major companies in the domestic ITP drug market include Jiangsu Aosaikang Pharmaceutical, Jiangsu Hengrui Medicine, and Shenyang Sanofi Pharmaceutical, among others [2][6] - Several companies have received approval for Eltrombopag, indicating a competitive environment for generic versions of the drug [6][7] ITP Drug Treatment Development Trends - The treatment of ITP is moving towards targeted and precision medicine, with new therapies showing potential in regulating key immune nodes [7] - Future research may explore the combination of Eltrombopag with existing therapies to enhance treatment outcomes and achieve long-term remission for patients [7]

Group 1 - The chairman of the board, Tang Weikun, increased his stake in Yuan Da Pharmaceutical (00512) by purchasing 50,000 shares at a price of HKD 8.28 per share, totaling HKD 414,000 [1] - After the purchase, the latest number of shares held by the chairman is 1,000,000, representing a holding percentage of 0.03% [1]

Core Viewpoint - The chairman of the board, Tang Weikun, has increased his stake in Yuan Da Pharmaceutical (00512) by purchasing 50,000 shares at a price of HKD 8.28 per share, totaling HKD 414,000, which reflects confidence in the company's future prospects [1] Summary by Category - **Shareholding Activity** - Tang Weikun acquired 50,000 shares of Yuan Da Pharmaceutical at HKD 8.28 each, amounting to HKD 414,000 [1] - Following this transaction, his total shareholding increased to 1,000,000 shares, representing a 0.03% ownership stake in the company [1]

Investment Rating - The report rates the industry as "Outperform" [2] Core Insights - The global market for Antibody-Drug Conjugates (ADC) is projected to exceed $100 billion, driven by the dual advantages of targeted therapy and potent cytotoxic effects [2][3] - ADCs are recognized as a promising new therapy in oncology, with the potential to redefine standard treatments for major cancers like lung and breast cancer [2][3] - China has emerged as a key player in ADC innovation, with over 50% of global ADC pipelines originating from Chinese companies, showcasing significant cost and efficiency advantages [2][3][5] Summary by Sections Section 1: ADC as a Targeted Prodrug - ADCs utilize a "Trojan horse" strategy for targeted delivery of cytotoxic agents to tumor cells, minimizing damage to normal tissues [11][13] - The mechanism involves several steps, including circulation, target binding, internalization, and release of the active drug within the tumor cell [11][13] Section 2: Market Growth and Trends - The ADC market is expected to enter a product explosion phase, with rapid growth anticipated in the coming years [2][3] - The global ADC market size is forecasted to reach $115.1 billion by 2032 [2] Section 3: Investment Opportunities - Investment in ADCs should focus on companies with innovative technology platforms and promising product candidates [2][3] - Key players to watch include those with leading ADC technology platforms and robust pipelines, such as Kelun-Biotech, Innovent Biologics, and WuXi AppTec [2][3] Section 4: Technological Advancements - ADC technology is characterized by modular upgrades and innovative combinations, with a variety of ADC types currently in development [2][3] - The report highlights the potential for ADC technology to extend into broader categories of conjugated drugs (XDC) [2][3] Section 5: Competitive Landscape - The report emphasizes the competitive nature of the ADC industry, with numerous players vying for market share and innovation [2][3] - Chinese ADC companies are recognized for their ability to lead in innovation and capture significant market opportunities [2][3][5]